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Reports on the results of clinical

studies of peptide bioregulators


of the CYTOMAX AND
CYTOGEN class.

CYTOMAXES AND
CYTOGENES

www.peptidesco.com
Reports on the results of clinical studies of
peptide bioregulators of the CYTOMAX AND
CYTOGEN class.

Introduction
The raging of the body is one of the most mysterious and relevant topics in modern medicine. For
centuries, scientists worldwide have been trying to answer these questions: how to prolong youth?
How to maintain good health? How to stay active for a long time? In Russia, this issue has been resolved
by the St. Petersburg Institute of Bioregulation and Gerontology under the guidance of Professor V.
Khavinson. As a result of numerous clinical studies, physiologically active proteins have been discovered
- peptides, which help the body naturally restore itself.

In the new edition, we combined all the scientifically proven results of the use of peptide bioregulators
of the Cytomax class (21 geroprotectors) and Cytogenes (6 geroprotectors). These studies confirm
that peptides of natural origin («Cytomaxes») harmonize metabolic processes in human cells. In the
long term, this reduces the risk of cancer, slows down premature aging, and increases life expectancy.
In turn, «Cytogenes», synthesized from natural amino acids, have a faster effect at the initial stage,
starting up the function of restoring internal organs. Physiologically active short peptides should be
used at any age to maintain a normal level of metabolic processes, prevent and treat various diseases,
for rehabilitation after serious illnesses, injuries, or surgeries, and for slowing down the body’s aging
process. Both classes of Peptides bioregulators have no side effects, as they contain peptides, which
are part of the human body.

For your convenience, we have added a section - recommendations for use.

With care,
Team Peptides
21 геропротектор
CYTOMAXES

The effectiveness of peptide bioregulators has been proven by many


years of clinical studies. Bioregulators based on natural peptides help slow
down premature aging and normalize metabolic processes in the body’s
cells, starting their natural renewal process and increasing life expectancy.
Cytomaxes are safe to use and have no side effects or withdrawal syndrome.
St. Petersburg Bonomarlot®

Report on the results of clinical studies of


the biologically active food supplement
BONOMARLOT®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Bonomarlot®

Biologically active food supplement BONOMARLOT® contains a complex of low molecular weight
peptides with a molecular weight of up to 5000 Da, extracted from bone marrow tissue of young
animals - calves not older than 12 months of age or pigs.
BONOMARLOT® is available in capsules with an active substance content of 10 mg.
BONOMARLOT® peptides regulate metabolic processes in the cells of the hematopoietic system,
increase its reserve capabilities, have a beneficial effect on the adaptation processes of the body in
extreme conditions, and have antioxidant properties regulating the processes of peroxidation in the
cells of the hematopoietic system. Experimental studies have shown that peptides have a tissue-
specific effect on the cells of those tissues from which they are isolated. This allows us to assume the
effectiveness of the use of BONOMARLOT® for restoring the functions of the hematopoietic system
in the case of its disorders of various origins, primarily in anemia.
Anemia is not an independent disease, but it occurs as a syndrome in a number of diseases that can
either be associated with a primary injury of the blood system or not depend on it. Therefore, anemia
is a widespread condition that requires targeted treatment, as the quality of life of people with anemia
is drastically reduced.
Any anemia leads to a decrease in the respiratory function of the blood and the development of oxygen
starvation of tissues, which is most often expressed by such symptoms as pallor of the skin, increased
fatigue, weakness, headaches, dizziness, rapid heartbeat, shortness of breath and others. A decrease
in hemoglobin concentration in the blood often occurs with a simultaneous reduction in the number
of red blood cells and their qualitative composition changes. In this case, it is essential to preserve
the ability of the bone marrow to regenerate, which is manifested by an increase in the number of
reticulocytes (young erythrocytes) in the peripheral blood (the norm is 0.5% -2%). Maintaining the
regenerative activity of the bone marrow helps to level the symptoms of anemia and improve the
patient’s general condition.
In general, the treatment tactics depend on the type of anemia and the severity of the patient’s
condition. Currently, vitamin B12 and iron supplements are mainly used to treat anemia. Also, with a
low hemoglobin level, red blood cell transfusions can be performed.

CLINICAL CHARACTERISTICS OF PATIENTS


A clinical study of the efficacy of BONOMARLOT® took place at the Medical Center of the Saint
Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of the Russian Academy
of Medical Sciences from April to November 2011.
The clinical study involved 26 women aged 35 to 56 years with signs of mild to moderate iron-
deficiency anemia due to malnutrition.
Patients complained of weakness, rapid fatigue, general malaise, decreased concentration, shortness
of breath after light or moderate physical activity, palpitations, headache, tinnitus, sleep, and appetite
disturbances.
An objective examination revealed pallor of the skin of visible mucous membranes and nail beds, as
well as the appearance of functional systolic murmurs in most patients.
During laboratory examinations, the patients showed a decrease in the hemoglobin content in the
blood to a level of 70-90 g/l, which indicates the presence of mild or moderate anemia.
All patients were divided into 2 groups. Patients in the control group (11 people) received conventional
therapy, including iron supplements, vitamin B12, and a special diet. In addition to conventional
treatment, patients of the primary group (15 people) received BONOMARLOT® 1 capsule 2 times a
day with meals for 30 days.

RESEARCH METHODS
We assessed the patients’ complaints and conducted general clinical blood tests during the study.

RESEARCH RESULTS
The use of BONOMARLOT® in patients with mild and moderate anemia improved the general condition,
Bonomarlot®

which was manifested in a decrease in weakness, rapid fatigue, general malaise, and shortness of breath
after light or moderate physical activity. The drug’s effect also decreased palpitations, headaches,
tinnitus, sleep disturbances, appetite, and increased concentration and performance (Table 1). It is
important to note that the improvement in the condition of patients of the primary group occurred in
a shorter time than in the control group, which used only conventional therapy. If in the patients of the
control group, the improvement in the condition occurred on average after 35.6 ± 2.7 days, then in the
patients of the primary group - after 26.2 ± 1.6 days. Thus, the time of improvement in patients with
anemia with the use of BONOMARLOT®, in addition to conventional therapy, was reduced by 24.4%.

Dynamics of subjective indicators in patients with anemia Table 1

Indicator Number of patients, %

Before treatment After treatment with After treatment with


conventional therapy (control BONOMARLOT® (primary
group) group)

Weakness 96,0 58,2* 25,4*#

Shortness of breath 78,2 48,5* 21,3*#

Rapid fatigability 82,2 63,2* 29,5*#

Reduced performance 92,4 67,3* 34,7*#

Tinnitus 74,1 42,1* 23,1*#

Decreased concentration of attention 89,5 57,5* 34,1*#

Headaches 68,4 41,8* 26,4*#

Palpitations 65,9 38,3* 21,7*#

Sleep disturbances 77,6 47,3* 29,1*#

* p <0.05 reliable in comparison with the indicator in patients before treatment;


#
p <0.05 reliable in comparison with the indicator in patients after treatment with conventional means.

Effect of BONOMARLOT® on the content of erythrocytes and hemoglobin in the Table 2


blood serum of patients with anemia

Indicator Norm Before After treatment with After treatment with


treatment conventional therapy BONOMARLOT®
(control group) (primary group)

Erythrocytes, (×10 12/l) 3,7-4,7 3,3±0,7 3,6±0,4 3,7±0,5

Hemoglobin, (g/l) 115-145 77,8±2,8 95,4±3,2* 112,6±4,2*#

* p <0.05 –reliable in comparison with the indicator in patients of the control group.
#
p <0.05 –reliable in comparison with the indicator in patients of the control group.

In the laboratory study, after the use of BONOMARLOT®, a significant improvement in the parameters
of the content of erythrocytes and hemoglobin in the blood was noted. As expected, it was more
pronounced than the indicators in the patients of the control group (Table 2).
The noted changes in the parameters in the peripheral blood of patients while taking BONOMARLOT®
correlate with clinical indicators. They indicate the restoration of an adequate response of the body’s
hematopoietic system in response to malnutrition.
Analysis of the data allows us to conclude that BONOMARLOT® has a normalizing effect on cellular
Bonomarlot®

metabolism in the tissues of the bone marrow, helps restore the functions of the hematopoietic system
in women with alimentary anemia.
Thus, the results obtained indicate the therapeutic efficacy of BONOMARLOT® and the practicality
of its use in the complex treatment of patients of different ages with anemia of various origins.
When using BONOMARLOT®, no side effects, complications, or drug dependence have been identified.
BONOMARLOT® can be used for therapeutic and prophylactic purposes in the form of a biologically
active food supplement combined with any means of symptomatic and pathogenetic therapy used to
treat anemia of various origins.

CONCLUSION
Biologically active food supplement BONOMARLOT® has a normalizing effect on the functional
activity of bone marrow cells.
BONOMARLOT® is well tolerated when taken orally, has no side effects, and can be used for
therapeutic and prophylactic purposes as a biologically active food supplement.
BONOMARLOT® is recommended for use to patients with anemia of various origins orally during
meals, 1-2 capsules 2 times a day for 30 days.
It is recommended to repeat the course of treatment after 3-6 months.

REFERENCES
1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. - M .: the Universe, 1993 .-- 398 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
3. Geriatric manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.
4. Pogorelov V.M., Kozinets G.I., Kovaleva L.G. Laboratory and clinical diagnostics of anemia. - M.,
2004 .-- 172 p.
5. Shiffman F.D. Clinical approach to patients with hematological profile. - In the book: Blood
pathophysiology. - SPb., 2001 .-- S. 43-71.

RECOMMENDATIONS FOR USE


BONOMARLOT® is a complex of peptides obtained from the bone marrow of young animals. The
extracted peptides have a selective effect on bone marrow cells, normalize metabolism in bone marrow
cells, and regulate the functions of the hematopoietic system.
Clinical studies established the effectiveness of BONOMARLOT® in the complex treatment of patients
with anemia of various origins when exposed to extreme environmental factors, malnutrition, and the
use of diets to reduce weight.
Bonomarlot® instructions: 1-2 capsules or tablets 1-2 times a day with meals. The duration of
administration is 30 days. It is advisable to repeat the course in 3-6 months.
Do not use if: you suffer from individual intolerance to the components, pregnancy, breastfeeding.
There were no side effects noticed when using BONOMARLOT®.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of BONOMARLOT®.
Expiration date: 3 years from the date of manufacture.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center Chief Physician of the LLC «Medical Center of
of the St. Petersburg Institute of Bioregulation the St. Petersburg Institute of Bioregulation and
and Gerontology, SZO RAMS» for clinical work, Gerontology, SZO RAMS», Candidate of Medical
Candidate of Medical Sciences (PhD in Medical Sciences (PhD in Medical Science)
Science), Associate Professor
St. Petersburg Bonothyrk®

Report on the results of clinical studies of the


biologically active food supplement
Bonothyrk®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Bonothyrk®

Biologically active food supplement BONOTHYRK® contains a complex of low molecular weight
peptides with a molecular weight of up to 5000 Da, isolated from the tissues of the parathyroid glands
of young animals - calves under 12 months of age or pigs.
BONOTHYRK® is available in capsules with an active substance content of 10 mg.
Experimental studies have shown that peptides have a tissue-specific effect on the cells of those
tissues from which they are isolated. BONOTHYRK® peptides regulate metabolic processes in the
cells of the parathyroid glands, increase their reserve capabilities while causing a beneficial effect on
the adaptation processes of the body in extreme conditions. They also possess antioxidant properties
and regulate the peroxidation processes in the tissues of the parathyroid glands. This allows us to
assume the effectiveness of BONOTHYRK® to restore the functions of bone tissue in case of injuries
of various origins, especially in women over 50 years old.
Bones become thinner, less solid, and elastic with age. This is partly because after you turn 35, calcium
escapes the bones more than it retains in bone tissue. This is common for everyone, but it is especially
pronounced in some people and leads to osteoporosis. Among all the factors that ensure the strength
of the skeleton, the ratio of calcium to magnesium is vital. When magnesium in the blood drops, the
kidneys regain balance, keeping less calcium in. When the concentration of magnesium increases, the
kidneys release less calcium. For this reason, the body primarily needs magnesium and vitamin B6,
which contributes to the retention of magnesium in the cells.
Osteoporosis affects the entire skeleton, especially hip- bones, bones of the forearm, and vertebrae.
Even a weak impact (for example, a fall in the street) can lead to a fracture. Moreover, in the case of
vertebrae, compression fractures can occur even in the absence of external influence - as a result of
the pressure created by the body’s own weight. This kind of damage, as well as the flattening of the
cartilaginous intervertebral discs due to their loss of elasticity, is the reason that in old age, a person
starts to shrink, and his posture deteriorates.
Osteoporosis is widespread in older women: after the age of 60, one in four suffers from it. In men, it
occurs four times less often. The fact is that before menopause (age-related cessation of menstruation),
the strength of the bones is maintained by estrogens, and after it, their level in the body decreases.
Estrogens are antagonists (agents with the opposite effect) of the parathyroid hormone, which
stimulates an increase in calcium concentration in the blood. This is due to the «washing out» of
calcium from the bones. Therefore, the deficiency of female sex hormones leads to a decrease in their
strength, that is, the likelihood of a fracture in elderly women increases.
To prevent osteoporosis, estrogens are prescribed, either to be taken orally or in the form of
subcutaneous implants. A balanced diet rich in natural vitamins, minerals (especially calcium), and
fiber, as well as regular exercise, also help maintain bone strength. The most effective prevention
of osteoporosis is the inclusion of whole grains in the diet (especially bread made from unrefined
wholemeal flour). The risk of developing osteoporosis increases with smoking, drinking, and a sedentary
lifestyle.
Given the significant number of contraindications and side effects when using hormone therapy,
it is important to continue the search for effective means that help prevent the development of
osteoporosis but do not cause side effects.

CLINICAL CHARACTERISTICS OF PATIENTS


A clinical study of BONOTHYRK® efficiency as part of the complex prevention of osteoporosis took
place at the Medical Center of the St. Petersburg Institute of Bioregulation and Gerontology in the
period from March to December 2011.
The clinical study involved 33 women aged 47 to 56 years with a mild to moderate climacteric syndrome
diagnosis, who showed a decrease in bone mineral density of more than 20% of the normal value,
which indicated an increased risk of osteoporosis.
The patients were divided into 2 groups. 13 people included in the control group did not take drugs
aimed at increasing bone mineral density. 20 patients in the primary group used BONOTHYRK® - 2
capsules 2 times a day for 30 days.
Bonothyrk®

The state of the bone tissue was determined by the method of X-ray densitometry and by observing
the dynamics of the decrease in bone mineral density - before the start of treatment and 3 months
after the end of the course of using BONOTHYRK®.

RESEARCH RESULTS
The use of BONOTHYRK® in patients with an initially reduced indicator of bone mineral density (BMD)
contributed to the prevention of the progression of bone tissue demineralization (table).

Dynamics of bone mineral density in patients with climacteric syndrome Table

Decreased BMD Number of patients,%

Initial level After 3 months. After 3 months using BONOTHYRK®


(control group) (main group)

15-20% 90,5 85,6 94,7

20-25% 9,5 14,4 5,3

* p <0.05 reliablein comparison with the indicator in patients before treatment;


#
p <0.05 reliable in comparison with the indicator in patients after treatment with conventional means.

As you can see from the data shown in the table, at the end of the course with BONOTHYRK®, the
progression of the decrease in bone mineral density in patients of the primary group slowed down. The
number of patients who had a decrease in BMD of no more than 20% increased from 90.5% (initially)
to 94.7% after the course of treatment, which indicates an emerging trend of inhibition of the process
of bone demineralization. In the control group patients who did not take drugs aimed at inhibiting the
process of bone demineralization, the number of patients with a decrease in bone mineral density of
more than 20% increased from 9.5% (initially) to 14.4% after 3 months, which creates an unfavorable
prognosis in terms of the development of osteoporosis.
Thus, the obtained results of the study indicate the preventive and therapeutic efficacy of
BONOTHYRK® and the advisability of its use in the complex treatment of patients of different ages
who are at risk of developing osteoporosis.
When using BONOTHYRK®, no side effects, complications, or drug dependence were observed.
BONOTHYRK® can be used for therapeutic and prophylactic purposes in the form of a biologically
active food supplement combined with any means of symptomatic and pathogenetic therapy used to
treat osteoporosis.

CONCLUSION
Biologically active food supplement BONOTHYRK® has a normalizing effect on the functional activ-
ity of bone cells.
BONOTHYRK® is well tolerated when taken orally, has no side effects, and can be used as a thera-
peutic and prophylactic biologically active food supplement.
BONOTHYRK® is recommended for the complex treatment of patients with early-stage osteoporo-
sis, orally during meals, 1-2 capsules 2 times a day for at least 30 days.
It is recommended to repeat the course of treatment after 3-6 months.
Bonothyrk®

REFERENCES
1. Benevolenskaya L.I. Osteoporosis - an urgent problem of medicine // Osteoporosis and Osteopa-
thy. - 1998. - №1 - 4-7pp.
2. Mikhailov E.E. Benevolenskaya L.N., Anikin S.G. et al. Osteoporosis and Osteopathy. 1999; 3: 2-6
3. RozhinskayaL.Ya. Systemic osteoporosis. M., 2001; with. 46-64
4. Chen XD, Shi S, Xu T, Robey PG, Young MF. Age-related osteoporosis in biglycan-deficient mice is
related to defects in bone marrow stromal cells. J Bone Miner Res. 2002Feb;17(2):331-40
5. Clarke H., Anderson H. An Antagonist of Osteoclast Integrins Prevents Experimental Osteoporosis
// J. Clin. Invest. Volume 99, Number 9, May 1997, 2059-2059
RECOMMENDATIONS FOR USE
BONOTHYRK® is a complex of peptides obtained from the parathyroid glands of young animals. The
extracted peptides have a selective effect on the cells of the parathyroid glands, normalize metab-
olism in the cells of the parathyroid glands, and regulate the functions of bone tissue, especially in
older women.
A clinical study established the effectiveness of BONOTHYRK® in the prevention and complex treat-
ment of patients with osteoporosis, including women over the age of 50.
Bonothyrk® instructions: 1-2 capsules or tablets with meals 1-2 times a day. The duration of admin-
istration is 30 days. It is advisable to repeat the course in 3-6 months.
Do not use if: you suffer from individual intolerance to the components, pregnancy, breastfeeding.
There were no side effects observed when using BONOTHYRK®.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of BONOTHYRK®.
Expiration date: 3 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Ventfort®

Report on the results of clinical studies of the


biologically active food supplement
Ventfort®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation and
Gerontology SZO RAMS, Corresponding Member of the Russian Academy
of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Ventfort®

The biologically active food supplement VENTFORT® contains a complex of low molecular weight
peptides with a molecular weight of up to 5000 Da, extracted from the tissue of the vessels (aorta) of
young animals - calves up to 12 months of age or pigs.
VENTFORT® is available in tablets or capsules with an active ingredient content of 10 mg.
Experimental studies have shown that peptides have a tissue-specific effect on the cells of those tis-
sues from which they are isolated. They improve the tropism of the cells of the tissues of the vascular
wall and have a regulatory effect on metabolic processes in them, contribute to the normalization of
functional and morphological changes in the vascular wall, regulate the content of cholesterol and
lipoproteins in the blood, reducing the risk of various vascular diseases. This suggests the effective-
ness of the use of VENTFORT® for the restoration of vascular function in various conditions, includ-
ing vascular atherosclerosis.
Atherosclerosis and its consequences are one of the leading causes of disability and death in devel-
oped countries. Changes in the vascular wall that increase with age and impaired hemodynamics lead
to decreased peripheral blood circulation, vascularization of organs and tissues, the development of
various components of oxygen deficiency, and trophic disorders (2, 3, 4, 6).
Drug treatment of atherosclerosis aims to normalize lipid metabolism, blood coagulation, and metab-
olism in the vascular wall (1, 5).

Medicines that normalize cholesterol and β-lipoprotein levels:


- Drugs, which prevent the absorption of cholesterol in the intestine (cholestyramine, β-sitosterol,
diosponin, polisponin);
- Drugs, which interrupt the synthesis of cholesterol in the body (clofibrate, miscleron, regardin, cet-
amifen, nicotinic acid, vitamin PP);
- Drugs, which enhance the splitting and excretion of cholesterol from the body (linetol, arachidene).
- Drugs, which improve microcirculation, normalize vascular permeability, reduce swelling of vascular
tissues and improve metabolic processes in the vascular wall (prodectin, dicinone, doxium, glivenol,
escuzan, etc.)
Clinical trials of VENTFORT® took place at the Medical Center of the Saint Petersburg Institute of
Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences
in patients with atherosclerosis of various arteries and senile purpura in the period from November
2005 to February 2006.

CLINICAL CHARACTERISTICS OF PATIENTS


The clinical trials involved 49 patients with atherosclerosis of the arteries and senile purpura, 27 of
whom made up the primary group (15 men, 12 women) - in addition to conventional drugs, they took
VENTFORT® orally 10-15 minutes before meals, 1-2 capsules 2-3 times a day for 10-15 days, de-
pending on the severity of the pathological process. Another 22 patients (11 men, 11 women) included
in the control group were prescribed only general-purpose drugs. The age of patients in both groups
ranged from 52 to 84 years (Table 1).
Patients of both groups had different clinical symptoms depending on the lesions of vessels of varying
caliber: hypertension, coronary heart disease, cerebrovascular disorders with impaired memory, con-
centration, and affective lability. All patients showed progressive dynamics of disease development.
All patients previously received symptomatic and pathogenetic therapy for specific clinical symptoms
of vascular pathology.
Ventfort®

Division of patients by nosological forms, sex and age Table 1

Diagnosis Age Male Female Total


(years)
Control Primary Control Primary Control Primary
group group group group group group

Atherosclerosis of the arteries 52-71 9 11 6 9 15 20

Senile purpura 72-84 2 4 4 3 7 7

Total 11 15 10 12 22 27

RESEARCH METHODS
The patients’ complaints were assessed in dynamics. A general clinical examination of blood and urine
and a biochemical study of blood on the «REFLOTRON» apparatus (Boehringer Mannheim, Germany)
were carried out. To study homeostasis, we assessed the blood coagulogram, and the Hess test was
carried out.

RESEARCH RESULTS
We found that the use of VENTFORT® in patients with arterial atherosclerosis contributed to the
improvement of general well-being, especially in patients with cerebrovascular disorders.
As can be seen from Table 2, the use of VENTFORT® contributed to a significant decrease in the lev-
el of total cholesterol in the blood. There was also a tendency towards a reduction of the content of
very-low-density lipoproteins, which are the most atherogenic.
The majority of patients have seen an improvement in skin and hair conditions. A significant increase
in the strength of the capillary walls was observed in patients with senile purpura after the use of
VENTFORT®, as evidenced by the results of the Hess test. The incidence of bleeding spots decreased.

Influence of VENTFORT® on lipid metabolism indicators Table 2

Indicator Before treatment After treatment with After treatment with


general-purpose drugs Ventfort®

Total cholesterol, 8,6±0,4 7,2±0,5* 6,0±0,7*


(mmol/l)

Very low-density lipoproteins, 1,32±0,05 1,13±0,07 0,91±0,07


(mmol/l)

Triglycerides, (mmol/l) 4,7±0,5 4,3±0,6 4,1±0,6

* P <0.05 –reliable in comparison with the indicator before treatment.

An improvement in the skin condition and an increase in the strength of the walls of the capillaries
were observed in patients with senile purpura after the application of VENTFORT®, as evidenced by
the results of the Hess test. The incidence of bleeding spots decreased.
Thus, the results of this study indicate the therapeutic efficacy of VENTFORT® and the viability of its
use in the complex treatment of atherosclerosis and vascular pathology.
When using VENTFORT®, no side effects, complications, contraindications, or drug dependence were
observed.
Ventfort®

The studied final form of VENTFORT® is convenient for in-hospital, outpatient, and home use.
VENTFORT® can be used for therapeutic and prophylactic purposes in the form of a biologically active
food supplement as a part of the complex therapy of vascular atherosclerosis and improvement of
microcirculation in various tissues in combination with any means of symptomatic and pathogenetic
treatment..

CONCLUSION
The biologically active food supplement VENTFORT® has a regulating effect on the content of
cholesterol and blood lipoproteins and improves the vascular wall condition.
VENTFORT® is well tolerated when administered orally, has no side effects, has no contraindications,
and can be used as part of the complex treatment and prevention of vascular diseases of various origins.
VENTFORT® is recommended to improve the functions of the vascular wall in atherosclerosis, impaired
microcirculation in organs and tissues in various diseases, and the effect of various extreme factors
on the body. It is also recommended for the elderly to maintain the function of the vascular system.
Recommended doses:
- For patients with vascular atherosclerosis - orally 10-15 minutes before meals, 1-3 capsules 2-3
times a day for 10-20 days;
- For patients with senile purpura - orally 10-15 minutes before meals, 1-3 capsules 2-3 times a day
for 10-30 days;
It is advisable to repeat the course of treatment every 3-6 months

REFERENCES
1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. - M .: the Universe, 1993 .-- 398 p.
2. Blood disorders in the elderly: Translation from English / Ed. M.J. Denham, I. Chanarin. - M.: Medicine,
1989 .-- 352 p.
3. Hormones and vascular diseases: Translation from English / Ed. R.M. Greenhalga. - M.: Medicine,
1984 .-- 344 p.
4. Korkushko O.V. Cardiovascular system and age. – M.: Medicine, 1983. – 176 p.
5. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
6. Geriatry manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.

RECOMMENDATIONS FOR USE


A complex of peptide fractions obtained from the vessels of young animals. The isolated peptides have
a selective effect on various vascular wall cells, normalize cell metabolism, and regulate the functions of
the vascular system. It is recommended to take 1-2 capsules of Ventfort® 1-2 times a day with meals.
The duration of admission is 30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of: individual intolerance to the components, pregnancy, or breastfeeding.
No side effects have been identified with the use of Ventfort®.
Store in a dry, dark place at a temperature of +2 to +25 oC. Release form: 20 or 60 capsules of 0.2 g.
Shelf life: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center Chief Physician of the LLC «Medical Center of
of the St. Petersburg Institute of Bioregulation the St. Petersburg Institute of Bioregulation and
and Gerontology, SZO RAMS» for clinical work, Gerontology, SZO RAMS», Candidate of Medical
Candidate of Medical Sciences (PhD in Medical Sciences (PhD in Medical Science)
Science), Associate Professor
St. Petersburg Visoluten®

Report on the results of clinical studies of the


biologically active food supplement
Visoluten®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Visoluten®

Biologically active food supplement VISOLUTEN® contains a complex of low molecular weight peptides
with a molecular weight of up to 5000 Da, isolated from the tissues of the eyes of young animals -
calves up to 12 months of age or pigs.
VISOLUTEN® is available in capsules with an active substance content of 10 mg.
VISOLUTEN® peptides regulate metabolic processes in the cells of the eye tissues, increase the reserve
capabilities of the organ of vision, have a beneficial effect on the adaptation processes of the body
in extreme conditions, have antioxidant properties, and regulate the processes of peroxidation in the
tissues of the eye. Experimental studies have shown that peptides have a tissue-specific effect on
the cells of those tissues from which they are isolated. This allows us to assume the effectiveness of
the use of VISOLUTEN® for the restoration of visual functions in case of disorders of various origins.
According to experimental data, VISOLUTEN® promotes the normalization of functional and
morphological disorders of the organ of vision.
The development of treatment tools that allow for the complete rehabilitation of patients with eye
injuries and their consequences, dystrophic diseases of various eyeball structures is an urgent and
complex problem in ophthalmology. Hereditary or post-traumatic insufficient vitality of eye tissues
often leads to their progressive destruction (1, 2).
Drug treatment of these diseases includes the use of the following drugs (1, 3):
- Vitayodurol, vitafacol;
- Vitamins B1, B6;
- Biostimulants (aloe, FiBS);
- etc.
The clinical study of VISOLUTEN® was carried out at the Medical Center of the St. Petersburg Institute
of Bioregulation and Gerontology from January to August 2011.
A clinical trial of VISOLUTEN® was carried out in patients with dystrophic diseases of the retina of
the eye of various etiologies and post-traumatic endothelial-epithelial corneal dystrophies. The study
involved 49 patients randomly divided into 2 groups - the control group (20 people) and the primary
group (29 patients). The distribution of patients by groups is shown in Table 1.
Patients in the control group received conventional therapy. In addition to conventional treatment,
patients of the primary group were prescribed VISOLUTEN® orally 10-15 minutes before meals, 1-3
capsules 2-3 times a day for 30 days, depending on the severity of the pathological process. For post-
traumatic visual impairments, VISOLUTEN® was prescribed in the rehabilitation period after surgery.
A progressive narrowing of the visual fields decreased visual acuity, degenerative changes in the retina
and narrowing of the retinal vessels were registered when examining patients.

Distribution of patients by diagnosis, sex and age. Table 1

Diagnosis Age Group Male Female Total

Retinal dystrophic diseases 51-70 Control 4 6 10

Primary 8 9 17

Posttraumatic endothelial-epithelial 20-43 Control 5 5 10


corneal dystrophies
Primary 7 5 12

Total: 24 25 49
Visoluten®

RESEARCH METHODS
All patients before and after the course of treatment were examined according to a comprehensive
clinical program, including, along with the obligatory - traditional methods, methods for diagnosing and
clarifying visual impairment, blood flow velocity, the state of the outer and inner layers of the retina,
the state of the retinal pigment epithelium.
Traditional examination methods included: a study of visual acuity and visual field, a study of dark
adaptation, a study of intracranial pressure, biomicroscopy of the anterior segment of the eyes, deep
optical media, biomicro-ophthalmoscopy, stereophthalmoscopy, direct ophthalmoscopy.
Diagnostic and clarifying examination methods included: visocontrastometry, static and multiple
central perimetry, color perception study, fundus fluorescence angiography, Doppler sonography,
electrophysiological studies.
A general clinical study of blood and urine, a biochemical study of blood on the apparatus «REFLOTRON»
(Boehringer Mannheim, Germany) were carried out.

RESEARCH RESULTS
Evaluation of clinical and laboratory functional parameters revealed changes in all parts of the eyeball
(iris, lens, vitreous body, optic nerve) in patients with degenerative diseases of the retina, which means
generalization of the pathological process with a tendency to progress as the disease progresses.
As a result of the studies, it was found that in the case of application of VISOLUTEN® in addition to
the conventional treatment, the maximum therapeutic effect was observed in patients with the initial
stages of degenerative changes in the retina. This was manifested in an increase in visual acuity and an
improvement in the electrophysiological parameters of the retina, the results of fluorescent angiography,
and changes in visual fields (expansion of the peripheral boundaries, reduction or disappearance of
paracentral scotomas). The research results are presented in tables 2 and 3.

Influence of VISOLUTEN® on the dynamics of visual acuity in patients Table 2


with degenerative diseases of the retina.

Visual acuity index Before treatment, (%) After Treatment with After Treatment with
Conventional Methods, (%) VISOLUTEN®, (%)

0,0 to 0,1 35,7 28,3 16,5

0,2 to 0,8 56,2 61,9 67,8

0,9 to 1,0 8,1 9,8 15,7

So, from the data in Table 2, it can be seen that when additional VISOLUTEN® was included in the
treatment regimen for patients of the primary group, visual acuity significantly increased in most
patients: the number of patients with visual acuity from 0.9 to 1.0 increased from 8.1% to 15, 7%, and
patients with visual acuity from 0.2 to 0.8 - from 56.2 to 67.8%, while the number of patients with
visual acuity below 0.1 - from 35.7% to 16.5 %. The pain indicators in the control group indicate the
insufficient effectiveness of the conventional treatment: the number of patients with visual acuity from
0.9 to 1.0 after the course of treatment remained practically unchanged, and the number of patients
with low visual acuity (from 0.0 to 0.1 ) decreased slightly - from 35.7% to 28.3%.
These data are consistent with the results of the electrophysiological study shown in Table 3. From
the data in Table 3, it can be seen that the electroretinography indices of both the «A» and «B»
waves, with the additional inclusion of VISOLUTEN®in the treatment regimen, significantly increase
Visoluten®

in comparison with the indicators before treatment and with indicators in the control group and
approaching the physiological norm. The indicators in the control group, whose patients received
conventional treatment, significantly differ from the before treatment but do not reach the boundaries
of the physiological norm.
The use of VISOLUTEN® in post-traumatic keratoconjunctivitis had a stimulating effect on the
cornea’s reparative regeneration, promoting the formation of more delicate corneal scars, increasing
the effectiveness of the treatment by 1.4 times and providing a more stable therapeutic effect in
comparison with the results in the control group. The phenomena of blepharospasm, photophobia, and
lacrimation in patients receiving VISOLUTEN® disappeared 2.4 times faster than in the control group.

The effect of VISOLUTEN® on electroretinography indicators in Table 3


patients with degenerative diseases of the retina

Indicators Norm Before Treatment After Treatment with After Treatment with
Conventional Methods Visoluten®

Wave «А» μV 30-60 18,6±1,0 24,6±1,6* 33,2±1,5*#

mS 15-25 19,7±1,3 22,5±2,7 23,1±1,9

Wave «В» μV 225-400 119,7±8,9 178,3±9,4* 216,3±10,3*#

mS 37-50 57,5±1,9 51,6±1,3 53,2±2,1

* p <0.05 - statistically significant in comparison with the indicator before treatment;


# p <0.05 - statistically significant in comparison with the indicator in the control group.

The appointment of VISOLUTEN® in the postoperative period after keratoplasty and vitreoretinal
operations made it possible in 86.7% of cases to prevent postoperative complications and shorten
the rehabilitation period.
VISOLUTEN® does not cause side effects, complications, or drug dependence.
The obtained results from the clinical study of the drug indicate the therapeutic efficacy of VISOLUTEN®
and the practicality of its use in the complex treatment of patients with dystrophic diseases of the retina
and post-traumatic epithelial-endothelial corneal dystrophies, keratoconjunctivitis, as well as in the
postoperative period in combination with symptomatic and pathogenetic drugs as an additional agent.

CONCLUSION
Biologically active food supplement VISOLUTEN®has a normalizing effect on the metabolism of the
eyeball tissues and helps restore the optical structures of the eye.
VISOLUTEN® is well tolerated when taken orally, has no side effects, and can be widely used as a
therapeutic and prophylactic biologically active food supplement.
VISOLUTEN® is recommended for use:
- To patients with degenerative diseases of the retina - orally 10-15 minutes before meals, 1-3 capsules
2-3 times a day for 15-30 days, depending on the severity of the pathological process;
- To patients with post-traumatic corneal dystrophies - orally 10-15 minutes before meals, 2-3 capsules
2-3 times a day for 15-30 days, depending on the severity of the pathological process;
- For prophylactic purposes in people whose professional activity is associated with eye strain, work in
dusty and smoky rooms - orally 10-15 minutes before meals, 1 capsule 2 times a day for 15-30 days.
According to indications, a second course of treatment is recommended after 3-6 months.
It is advisable to recommend VISOLUTEN® for therapeutic and prophylactic use and industrial
production.
Visoluten®

REFERENCES
1. Danilichev V.F., Khavinson V.Kh., Vasilieva L.A. Treatment of peripheral pigmentary tapetoretinal
abiotrophy // Ophthalmological journal. - 1992. - No. 3. - S. 174 - 178.
2. Maksimov I.B. Complex peptide correction in microsurgical treatment of eye injuries and their
consequences (experimental clinical study): Abstract of the thesis. diss. .... Dr. med. sciences. - M.,
1996 .-- 36 p.
3. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
RECOMMENDATIONS FOR USE
VISOLUTEN® is a complex of peptides obtained from the tissues of the eyes of young animals. The
isolated peptides have a selective effect on various cells of the eye’s tissues (retina, lens, cornea), nor-
malize metabolism in cells, and regulate their functions.
In the clinical study, the effectiveness of VISOLUTEN® was established for the complex restoration
of the functions of the organ of vision after diseases of various origins, including monetary-dystrophic,
in pathological conditions leading to impaired visual function, exposure to extreme environmental
factors, including occupational, malnutrition, as well as aging.
VISOLUTEN® instructions: 1-2 capsules or tablets of VISOLUTEN® 1-3 times a day with meals. The
duration of admission is 30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of: individual intolerance to the components, pregnancy, breastfeeding.
No side effects have been identified while using VISOLUTEN®.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of VISOLUTEN®.
Expiration date: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Vladonix®

Report on the results of clinical studies of the


biologically active food supplement
Vladonix®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Vladonix®

The biologically active food supplement VLADONIX® contains a complex of low molecular weight
peptides with a molecular weight of up to 5000 Da, extracted from the thymus tissue of young ani-
mals - calves up to 12 months of age or pigs.
VLADONIX® is available in tablets or capsules with an active ingredient content of 10 mg.
VLADONIX® peptides regulate metabolic processes in the cells of the immune system, restore im-
paired immunological reactivity, and stimulate regeneration processes if they are suppressed. Experi-
mental studies have shown that peptides have a tissue-specific effect on the cells of those tissues from
which they are isolated. This suggests the effectiveness of VLADONIX® for restoring the function of
the immune system in various pyoinflammatory and other diseases characterized by the suppression
of the immune status of patients.
We know that various physical, chemical, and biological factors, depending on the duration or intensity
of their impact on the human body, can weaken adaptive and compensatory mechanisms and cause
profound disorders in various links of the immune defense system (2, 3).
Pathological disorders in the immune system usually contribute to a long course of the underlying
disease with a tendency to relapse, a decrease in the body’s resistance to infection, and the develop-
ment of severe complications.
Among the means that contribute to the restoration of immunological reactivity, immunomodulators
of various origins are considered: enzyme preparations (trypsin, lysozyme), bacterial polysaccharides
(pyrogenal, prodigiosan), yeast polysaccharides (zymosan, glucans, propermil, dextrans), vaccines (BCG),
nucleic acid medication ( sodium nucleinate), purine and pyrimidine derivatives, levamisole, diucifon,
traditional medicine and many others (1, 2).
Clinical trials of VLADONIX® took place from November 2005 to February 2006 at the Medical Cen-
ter of the Saint Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of
the Russian Academy of Medical Sciences, in patients exposed to long-term influence of low doses of
ionizing radiation, including oncological patients after radiation and chemotherapy.
The primary group consisted of 42 patients (23 men, 19 women), who, in addition to conventional
treatments, were prescribed VLADONIX® 1-3 capsules 2-3 times a day before meals for 15-20 days,
depending on the severity of their immune status disorders. Patients in the control group received
only general-purpose drugs. The age of patients in both groups ranged from 34 to 65 years. The dis-
tribution of patients by nosological forms, sex, and age is presented in Table 1.
Distribution of patients by nosological forms, sex and age Table 1

Diagnosis Age (years) Male Female Total

Control Primary Control Primary Control Primary


group group group group group group

Condition after exposure to low 34-51 12 14 6 8 18 22


doses of ionizing radiation

Condition after radiation and 45-65 7 8 9 12 16 20


chemotherapy in cancer patients

Total 19 22 15 20 34 42

RESEARCH RESULTS
VLADONIX® efficiency was assessed by the changes in patients’ complaints and by a number of
objective indicators: general clinical examination of blood and urine, immunological examination of
peripheral blood (the number of T- and B-lymphocytes was determined by the method of immuno-
fluorescence with monoclonal antibodies obtained to the differentiation antigens of lymphocytes
CD3, CD4, CD8, CD20; the content of immunoglobulins of various classes - by the method of radial
immunodiffusion in gel according to Mancini; functional activity of T-lymphocytes - in the reaction of
inhibition of lymphocyte migration (RTML) with ConA).
Vladonix®

Studies have shown that 92% of people living in an ecologically unfavorable territory have disorders in
the immune status, manifested in a decrease in the number of CD3+, CD4+ cells, with a slight increase
in lymphocytes with the CD8+ phenotype, which indicates a reduction in the level of immunoreactiv-
ity (CD4+/CD8+). The results of RTML with ConA characterize a decrease in the functional activity of
T-lymphocytes (mainly CD8+, i.e., T-suppressors/killers). The content of CD20+ - cells, representing
a subpopulation of B-lymphocytes, did not significantly differ from normal values. Still, an increase in
the amount of immunoglobulins M and G in the blood serum was observed (Table 2).
It should be noted that the quantitative indicators of the content of CD3+ and CD4+ - cells are char-
acteristic of the lower limits of physiological fluctuations in their number in patients of this age, which
may indicate the weakening and premature aging of the immune system. As a rule, patients with a
secondary immunodeficiency state had a pronounced asthenic syndrome and significant changes in
the cardiovascular system.
Influence of VLADONIX® on indicators of cellular and humoral immunity in Table 2
individuals exposed to low doses of ionizing radiation
Indicators Before treatment After treatment with After treatment with

Leukocytes, х109/l 5,0±0,2 5,4±0,1 5,6±0,1

Lymphocytes, % 26,2±2,6 31,4±2,4 35,1±2,1


х109/l 1,51±0,08 1,64±0,05 1,87±0,05

CD3+, % 46,5±2,3 51,9±2,2 55,7±2,6*


х109/l 1,53±0,09 1,65±0,07 1,86±0,05*

CD4+, % 28,5±2,8 30,8±2,1 34,6±2,0*


х109/l 0,41±0,01 0,49±0,07 0,67±0,09*

CD8+, % 26,4±1,5 25,7±1,6 24,9±1,8


х109/l 0,43±0,05 0,42±0,03 0,46±0,07

CD4+/CD8+
1,1 1,2 1,4*

CD20+, %
х109/l 12,3±0,6 12,0±0,4 12,0±0,7
0,18±0,01 0,21±0,01 0,20±0,01

RTML, % 88,1±5,4 76,2±4,8* 70,4±4,9*

IgM, (g/l) 1,82±0,06 1,72±0,05 1,66±0,06

IgG, (g/l) 15,7±1,3 15,6±1,6 15,3±1,7

IgА, (g/l) 2,2±0,1 2,0±0,1 2,1±0,3

* P <0.05 –reliable in comparison with the indicator before treatment.

The results of the studies conducted convincingly indicate that VLADONIX® is an effective remedy for
correcting secondary immunodeficiencies that develop in response to exposure to extreme factors.
The use of VLADONIX® in combination with symptomatic agents made it possible to normalize the impaired
parameters of the immune system in 78% of cases.
As follows from the data presented above, the most significant effect from the use of VLADONIX® was
observed in relation to subpopulations of T-lymphocytes and their functional activity (a significant increase in
the content of CD3+ and CD4+ lymphocytes, normalization of the CD4+/CD8+ ratio). A less distinct reaction
took place on the part of the B-system of the immune system, probably due to its greater conservatism.
After the course of treatment with VLADONIX®, patients who received small doses of ionizing radiation
noted a significant improvement in their general condition and a decrease in the severity of the asthenic
syndrome, which always accompanies secondary immunodeficiencies.
In oncological patients, after radiation and chemotherapy, an accelerated normalization of immunological
parameters was noted compared to the control group, which led to an improvement in overall well-being
Vladonix®

and a decrease in the incidence of complications. It is noteworthy that the patients of the primary group
tolerated radiation and chemotherapy more easily. All were able to complete the entire course of radiation
therapy (in the control group - 79%).

CONCLUSION
Clinical trials have shown that VLADONIX® contributes to the normalization of cellular immunity indicators
and stimulates tissue regeneration processes in the event of their suppression. It does not cause side effects,
complications, or drug dependence. It can be used for therapeutic and prophylactic purposes in combination
with any means of symptomatic and pathogenetic therapy used to correct secondary immunodeficiency
states (immunomodulators, adaptogens, vitamins, etc.).
VLADONIX® is recommended to be used to accelerate the restoration of the functions of the immune
system after infectious diseases, radiation, and chemotherapy, exposure of the body to various extreme
factors (including ionizing and microwave radiation). It is also recommended for the elderly to maintain the
functions of the immune system.
It is recommended to take VLADONIX® 10-15 minutes before meals, 1-3 capsules 2-3 times a day for
20-30 days.
A second course is desirable in 3-6 months.
There were no side effects, complications, contraindications, or drug dependence observed during the
clinical study when using VLADONIX®.

REFERENCES
1. Drannik G.N., Grinevich Y.A., Disik G.M. Immunotropic medication. – Kiev Zdorov’ya, 1994. – 288 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
3. Novikov V.S., Smirnov V.S. Immune physiology of extreme conditions. – SPb.: Nauka, 1995. – 172 p.
4. Schek M.G., Kosinets A.N., Adamenko G.P. Immunological aspects of surgical infection. – Vitebsk: B. i.,
1994. – 140 p.
RECOMMENDATIONS FOR USE
The drug contains a complex of peptide compounds isolated from the thymus of healthy calves aged
between 6-12 months. The peptides included in VLADONIX® selectively act on the cells of the im-
mune system, regulating its functions and normalizing cell metabolism. The drug will help comprehen-
sively restore the immune system after past illnesses, after being exposed to extreme environmental
factors, unbalanced nutrition, aging, and pathological conditions, as a result of which the functions of
the immune system are impaired.
Depending on the goals (prevention, treatment) and the severity of pathological manifestations,
VLADONIX® is taken for 10-20 days.
Adults: 1-2 capsules 1-2 times a day with meals. The duration of admission is 30 days. Do not use in
case of: individual intolerance to the components, during pregnancy or breastfeeding. No side effects
have been identified.
It is recommended to repeat the course of treatment after 6 months. Store in a dry, dark place at a
temperature of +2 to +25 oC. Release form: 20 or 60 capsules of 0.2 g.
Shelf life: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center Chief Physician of the LLC «Medical Center of
of the St. Petersburg Institute of Bioregulation the St. Petersburg Institute of Bioregulation and
and Gerontology, SZO RAMS» for clinical work, Gerontology, SZO RAMS», Candidate of Medical
Candidate of Medical Sciences (PhD in Medical Sciences (PhD in Medical Science)
Science), Associate Professor
St. Petersburg Glandokort®

Report on the results of clinical studies of the


biologically active food supplement
Glandokort®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Glandokort®

Biologically active food supplement GLANDOKORT® contains a complex of low molecular weight
peptides with a molecular weight of up to 5000 Da, extracted from adrenal tissues of young animals
- calves notolder than 12 months of age or pigs.
GLANDOKORT® is available in capsules with an active substance content of 10 mg.
Experimental studies have shown that peptides have a tissue-specific effect on the cells of those
tissues from which they are isolated. GLANDOKORT® peptides regulate metabolic processes in the
adrenal cortex cells, increase their reserve capacity, and have a beneficial effect on the adaptation
processes of the body in extreme conditions. They also possess antioxidant properties and regulate the
peroxidation processes in the tissues of the adrenal glands. This allows us to assume the effectiveness
of GLANDOKORT® for restoring the functions of the endocrine system in case of their disorders of
various origins, including with prolonged exposure to stress factors, with aging.
Age-related or stress-induced decrease in the functional activity of the adrenal glands is one of the
causes of dyshormonal and maladaptive disorders (3, 4).
Drug treatment of these diseases and pathological conditions includes the use of the following drugs
(1, 2):
- Glucocorticoids - prednisolone, hydrocortisone;
- Mineralocorticoids;
- Adaptogens (ginseng, extracts of Eleutherococcus, Leuzea, Rhodiola rosea, tinctures of aralia, zamanihi,
saparal, pantocrine).

CLINICAL CHARACTERISTICS OF PATIENTS


A clinical study of the effectiveness of the use of GLANDOKORT® was carried out at the Medical
Center of the St. Petersburg Institute of Bioregulation and Gerontology in the period from April to
November 2011.
The study involved 36 patients aged 37 to 62 years, including 25 men and 11 women, with chronic
adrenal cortex insufficiency and conditions after prolonged exposure to occupational and psycho-
emotional stress. Patients of the primary group received complex treatment using adaptogens
(conventional medicine) and GLANDOKORT® 1 capsule 2 times a day with meals for 30 days.
The control groups consisted of 26 patients with similar diseases who were prescribed conventional
treatment with adaptogens. Patients receiving hormone therapy were excluded from the study.
Patients suffering from a chronic adrenal cortex insufficiency or under occupational or psycho-
emotional stress for a long time complained of general weakness, decreased appetite, headaches,
sleep disturbances, increased irritability, and apathy.

RESEARCH METHODS
The effectiveness of GLANDOKORT® was assessed subjectively by studying the dynamics of patients’
complaints and objective indicators. A biochemical blood test was carried out for a general clinical study
of blood and urine. The content of hormones (cortisol, insulin) in the blood serum was determined
by radioimmunological methods. Using various biochemical processes, we defined the content of
adrenaline and aldosterone in the blood plasma. The level of excretion of 17-ketosteroids was found
in the urine.

RESEARCH RESULTS
It was found that the use of GLANDOKORT® contributed to the improvement of the general condition
of patients in the studied group. Patients noted increased physical and mental performance, improved
mood, and sleep.
Glandokort®

Influence of GLANDOKORT® on the level of adrenal hormones in patients with ТTable 1


chronic adrenal cortex insufficiency

Indicator Norm Before treatment After treatment with After treatment with
conventional methods Glandokort®

Aldosterone in blood plasma, (pg/ml) 7,5-150 14,7±1,2 26,2±1,6 38,5±1,3*,**

17-ketosteroids common in urine, 17-70 19,8±1,6 38,2±2,4 46,3±2,1*


(μmol/day)

* p <0.05 - significant in comparison with the indicators before treatment;


** p <0.05 - significant in comparison with the indicators in the control group.

Patients with chronic adrenal cortex insufficiency, taking GLANDOKORT®, showed positive results.
There was a restoration of the metabolic activity of the reticular adrenal zone, accompanied by an in-
crease in the production of aldosterone and 17-ketosteroids, the content of which increased to the
average values of the norm (Table 1).

Effect of GLANDOKORT® on plasma levels of cortisol and adrenocorticotropic


hormone in subjects exposed to prolonged occupational or psycho-emotional stress. Table 2

Indicator Norm Before Treatment After treatment with After treatment with
conventional methods Glandokort®

Cortisol (nmol/L) 250-750 287,5±18,5 311,4±21,4 431,4±25,7*,**

ACTH (pg/ml) 10-80 14,2±1,1 17,4±1,3 28,6±1,1

* p<0.05 - significant in comparison with the indicators before treatment.

The use of GLANDOKORT® in persons exposed to prolonged exposure to professional or


psycho-emotional stress contributed to stabilizing the hormonal status, which indicates the
leveling of maladjustment disorders and catabolic reactions (Table 2). The content of cortisol and
adrenocorticotropic hormone (ACTH) before the start of treatment was noted at the lower limit of
the norm, which indicated the depletion of the reserves of the adrenal cortex—after complex therapy
using GLANDOKORT®, the level of cortisol and ATKG in the blood plasma returned to normal. These
changes were correlated with improvements in subjective scores.
No side effects, complications, or drug dependence were identified when using GLANDOKORT®.

CONCLUSION
Biologically active food supplement GLANDOKORT®has a normalizing effect on the functional activity
of adrenal cortex cells.
GLANDOKORT® is well tolerated when taken orally, has no side effects, and can be used as a
therapeutic and prophylactic biologically active food supplement.
GLANDOKORT® is recommended for use orally with meals, 1-2 capsules two times a day for 30 days,
for patients with impaired adrenal cortex function or prolonged exposure to professional or psycho-
emotional stress.
It is recommended to repeat the course in 3-6 months.

REFERENCES:
1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. - M .: the Universe, 1993 .-- 398 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
Glandokort®

1993.
3. Geriatric manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.
4. Tepperman J., Tepperman H. Physiology of metabolism and the endocrine system: Translation from
English - M .: Mir, 1989 .-- 656 p.

RECOMMENDATIONS FOR USE:


GLANDOKORT® is a complex of peptides obtained from the adrenal glands of young animals. The
isolated peptides have a selective effect on adrenal cells, normalize their metabolism, and regulate the
functions of the endocrine system.
The effectiveness of GLANDOKORT® was confirmed in a clinical study. It proved its usefulness in the
complex treatment of patients with dysfunction of the adrenal cortex, with prolonged exposure to
professional or psycho-emotional stress, to restore the functions of the endocrine system after diseas-
es of various origins, when exposed to extreme environmental factors, malnutrition, as well as aging.
Glandokort® instructions: 1-2 capsules or tablets with meals 1-2 times a day. The duration of admis-
sion is 30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of: individual intolerance to the components, pregnancy, breastfeeding.
No side effectshave been identified during the use of GLANDOKORT®.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of GLANDOKORT®.
Expiration date: 3 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Gotratiх®

Report on the results of clinical studies of the


biologically active food supplement
Gotratiх®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Gotratiх®

Biologically active food supplement GOTRATIХ® contains a complex of low molecular weight peptides
with a molecular weight of up to 5000 Da, isolated from the tissues of the triceps muscle of young
animals - calves notolder than 12 months of age or pigs.
GOTRATIХ® is available in capsules with an active substance content of 10 mg.
Experimental studies have shown that peptides have a tissue-specific effect on the cells of those
tissues from which they are extracted. GOTRATIХ® peptides regulate metabolic processes in muscle
cells, increase their reserve capacity, have a beneficial effect on the adaptation processes of the body
in extreme conditions, and have antioxidant properties, regulating the processes of peroxidation in
muscle tissues. This allows us to assume the effectiveness of the use of GOTRATIХ® for the restoration
of muscle functions during intense physical activity and sports.
To improve the physical performance of athletes and their adaptation to increased physical and psycho-
emotional stress, various means and methods of pharmacological and, more recently, genetic correction
are very actively used (Seifulla, 1999; Yakimov, 2001). It is incontrovertibly proven that athletes using
prohibited pharmacological drugs cannot demonstrate stable high athletic form for a long time since
they experience physiological breakdowns under increased pressure (Semenov et al., 2002). The danger
is aggravated by the fact that many new stimulating substances appear, the doping effect of which is
«masked» by various food and vitamin supplements (Mikhailov, 2006).
Therefore, the problem of early detection of the negative consequences of taking modern doping
substances is not the only issue. The development of a complex of methods for bioregulation of
physiological reserves of highly qualified athletes to effectively prevent physical maladjustment in the
dynamics of the training cycle also poses a problem.
Maintaining the reserve capacity of the muscular system is an urgent problem for people who are
engaged in a feasible physical culture, including the elderly.

CLINICAL CHARACTERISTICS OF PATIENTS


The effectiveness of using GOTRATIХ® was determined by the dynamics of changes in speed-strength
qualities using tests: measurement of maximum wrist dynamometry (right and left hand), long jump
from a standing position.
Endurance was determined using a test that is an interpretation of the Harvard step test. Flexibility
was determined using an exercise: bending forward while standing on a gymnastic bench.

RESEARCH RESULTS
The use of GOTRATIХ® contributed to improving the general condition of patients in the studied
group. Patients noted an increase in physical performance. The table presents a comparative analysis
of the indicators of the primary and control groups during two tests, in which the examined control
groups trained according to the usual plan, and the primary group took GOTRATIХ®in addition to the
usual workout. The interval between tests was two months.
The table shows that the indicators of speed-strength qualities of dynamometry and long jump in the
primary group significantly increased compared to the initial indicators. In contrast, they remained
at the same level in the examined control group. The indicators of the step test and flexibility in the
subjects taking GOTRATIХ® tended to increase in comparison with the initial data but did not differ
significantly.
While taking GOTRATIХ®, the subjects noted less fatigue during training than the initial level, better
workability, and faster muscle recovery after exercis
Gotratiх®

Influence of GOTRATIХ® on the dynamics of parameters of physical Table


qualities in men, M ± m

№ Test Dynamometry Long Jump, Step-Test, 1 step Flexibility Test, cm


Test Group cm

Right hand, Left hand, kg


kg

Control Group, n = 17
46±1,4 43±1,3 212±6 53±6,3 6,3±2,1
1 Primary Group, n = 22
47±2,1 42±1,7 215±4 55±3,1 7,0±1,1

Control Group, n = 17
47±1,6 45±1,8 219±6 57±7,5 7,5±1,7
2 Primary Group, n = 22
53±3,9* 48±1,4* 231±3* 58±6,8 9,2±2,1

* - The differences are statistically significant (p <0.05): the second test compared to the first in the corresponding group.

Thus, the use of GOTRATIХ® contributed to an increase in the effectiveness of physical exercises,
less fatigue.
In using GOTRATIХ®, no side effects, complications, or drug dependence were identified.

CONCLUSION
Biologically active food supplement GOTRATIХ® has a normalizing effect on the functional activity
of muscle cells.
GOTRATIХ® is well tolerated when taken orally, has no side effects, and can be used as a therapeutic
and prophylactic biologically active food supplement.
GOTRATIХ® is recommended for people of different ages with increased physical activity, including
sports. It is taken orally with meals, 1-2 capsules 2-3 times a day for 30 days.
According to indications, a second course of treatment should be carried out after 3-6 months.

REFERENCES
1. Buresh L., Bureshova O., Houston J. Methods and main experiments for the study of the brain and
behavior. - M., 1991. -- 399 p.
2. Verbitsky E.V. Psychophysiology of anxiety. - Rostov-on-Don: Publishing house of the Russian State
University. - 2003. - 192 p.
3. Vovk S.I. Features of long-term dynamics of fitness // theory and practice of physical culture. - 2001,
No. 2. - P. 28-31.
4. Ivko O.M. The influence of sports injuries on the quality of life of sports veterans in old and senile
age // Abstract of the thesis ... Candidate of Biological Sciences: 14.00.53- SPb, 2007. - 25 p.
5. Korkushko O.V., YaroshenkoYu.T. Maximum oxygen consumption in men depending on age and level
of physical activity // Human Physiology. - 1996. - T.22, No. 4. - P. 100-103.
6. Kulinenkov O.S. Pharmacological assistance to an athlete: correction of factors limiting sports
performance // M, 2006. - 240 p.
7. Lysenko A.V. Arguments in favor of the use of biologically active peptides in the practice of sports
pharmacology // Theory and practice of physical culture. - 2004. - No. 10. - P. 25-29.
Gotratiх®

RECOMMENDATIONS FOR USE


GOTRATIХ® is a complex of peptides obtained from the muscles of young animals. The isolated pep-
tides have a selective effect on muscle cells, normalize their metabolism, and regulate the functions
of the muscular system.
In a clinical study, the use of GOTRATIХ® was established to increase the effectiveness of intense
physical activity, including during sports, to restore the functions of the muscular system after diseases
of various origins, under the influence of extreme environmental factors, malnutrition, as well as aging.
GOTRATIХ® is recommended: 1-2 capsules or tablets 2-3 times a day with meals. The duration of
admission is 30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of: individual intolerance to the components, pregnancy, breastfeeding.
No side effectshave been identified when using GOTRATIХ®.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of GOTRATIХ®.
Expiration date: 3 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Zhenoluten®

Report on the results of clinical studies of the


biologically active food supplement
Zhenoluten®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Zhenoluten®

Biologically active food supplement ZHENOLUTEN® contains a complex of low molecular weight
peptides with a molecular weight of up to 5000 Da, isolated from the tissues of the triceps muscle of
young animals - calves notolder than 12 months of age or pigs.
ZHENOLUTEN® is available in capsules with an active substance content of 10 mg.
ZHENOLUTEN® peptides regulate metabolic processes in ovarian cells, increase their reserve ca-
pacity, have a beneficial effect on the body’s adaptation processes in extreme conditions, and have
antioxidant properties, regulating the peroxidation processes in ovarian tissues. Experimental studies
have shown that peptides have a tissue-specific effect on the cells of those tissues from which they
are isolated. This allows us to assume the effectiveness of the use of ZHENOLUTEN® to restore the
functions of the reproductive system in women with disorders of various origins.
Age-related or pathological changes in ovarian function are characterized by the development of a
complex symptom-complex with the manifestation of neuropsychic, vasomotor, and metabolic-endo-
crine disorders, combined into the concept of «climacteric syndrome» (1, 4, 5). These disorders occur
in women over the age of 45; they significantly reduce their quality of life.
Currently, non-hormonal and hormonal medications are used to treat menopause and ovarian wasting
syndrome, many of which have severe contraindications and side effects (2, 3):
- Sympatholytics - reserpine, obsidan;
- Anticholinergics - belladonna tincture;
- Antihistamines - tavegil, suprastin;
- Tranquilizers - tazepam;
- Vitamins B1, B6, E;
- Steroid estrogens - estradiol dipropionate, folliculin, ethinylestradiol, estriol;
- Gestagens (progestins) - progesterone, turinal, norkolut, premalut-nor, pregnin;
- Combined estrogen-gestagenic drugs - biseurin, non-ovlon;
- etc.

CLINICAL CHARACTERISTICS OF PATIENTS


A clinical study of the efficacy of ZHENOLUTEN® was carried out at the Medical Center of the St.
Petersburg Institute of Bioregulation and Gerontology from April to November 2011.
The clinical study involved 39 women aged 45 to 53 years with a mild to moderate climacteric syn-
drome diagnosis and 28 women aged 38 to 43 years diagnosed with the ovarian wasting syndrome
(early climacteric syndrome).
Patients complained of hot flashes to the head and upper body, accompanied by increased sweating,
headache, and surges in blood pressure, pain in the heart, chills, tachycardia attacks at rest, a tendency
to fainting, nausea, a feeling of «sinking» of the heart, dizziness, and weakness. Psychoemotional dis-
orders were most often manifested by irritability, tearfulness, anxiety, sleep disturbances, decreased
memory and attention, rapid fatigue, and decreased physical and mental performance. Patients noted
an increase in the incidence of respiratory infectious diseases.
During laboratory examination, the patients were found to have hormonal disorders characterized by
increased levels of FSH and LH in the peripheral blood in patients with climacteric syndrome. More-
over, in patients diagnosed with ovarian wasting syndrome, an increase in the level of FSH and LH was
noted several times. It was accompanied by a significant decrease in estradiol content in the periph-
eral blood. General clinical and biochemical parameters in the blood did not go beyond the age norm.
All patients were divided into 4 groups: 2 control and 2 primary in accordance with the diagnoses. Pa-
tients in both control groups received conventional therapy, which did not include hormonal drugs. In
addition to conventional treatment, patients of both main groups received ZHENOLUTEN® 1 capsule
2 times a day with meals for 30 days.
All patients were divided into 4 groups: 2 control and 2 primary following the diagnoses. Patients in
both control groups received conventional therapy, which did not include hormonal drugs. In addi-
tion to conventional treatment, patients of both primary groups received ZHENOLUTEN® 1 capsule
2 times a day with meals for 30 days.
Zhenoluten®

RESEARCH METHODS
The patients’ complaints were assessed in progression, a general clinical examination of blood and
urine, a biochemical study of blood on the REFLOTRON apparatus (Boehringer Mannheim, Germany)
were carried out. Ultrasound examination of the ovaries was performed using an ultrasound machine
(ALOKA, Japan). The content of hormones (FSH, LH, and estradiol) in the blood serum was determined
by radioimmunoassay. The radioactivity of the samples was counted on a «Tracor Analytic 1285»
counter (USA-Holland).

RESEARCH RESULTS
It was found that the use of ZHENOLUTEN® in patients with mild and moderate climacteric syndrome
contributed to an improvement in the general condition, which was manifested in a decrease in the
number of hot flashes, improved sleep, appetite, and increased efficiency (Table 1).

Dynamics of subjective indicators in patients with climacteric Table 1


syndrome.

Indicator Number of Patients. %

Before Treatment After Treatment with Conventional After Treatment with


Methods (Control Group) ZHENOLUTEN® (Primary
Group)

Hot flushes in the head and 72,0 55,1* 31,8*#


upper body.

Increased sweating. 67,8 50,7* 29,6*#

Fast fatiguability. 68,8 51,3* 31,4*#

Reduced performance. 81,6 53,1* 32,6*#

Irritability. 91,8 54,2* 33,3*#

*p <0.05 compared with the indicator in patients before treatment;


# p <0.05 compared with the indicator in patients after treatment with conventional methods.

In laboratory studies, after the application of ZHENOLUTEN®, a significant decrease in the content of
FSH and LH was noted, which caused an increase in the LH / FSH index to the lower limits of age-re-
lated physiological fluctuations (Table 2).
The noted changes in the hormonal status of patients while taking ZHENOLUTEN® correlate with
clinical indicators. They indicate the restoration of the adequate adaptive response of the aging or-
ganism in response to an age-related decrease in ovarian function.

Effect of ZHENOLUTEN®on the content of pituitary hormones in blood serum Table 2


of patients with climacteric syndrome.

Indicator Norm Before Treatment After Treatment with After Treatment with
Conventional Drugs (Control ZHENOLUTEN®
Group) (Primary Group)

FSH, (IU / ml) 1,5-45 89,3±3,5 71,6±6,3* 46,8±3,9*#

LH, (IU / ml) 2-17 28,1±1,9 25,7±2,4 16,4±1,4*#

* p <0.05 - statistically significant compared with the indicator before treatment.


# p <0.05 - statistically significant in comparison with the indicator in patients of the control group.
Zhenoluten®

In patients with ovarian depletion syndrome, the use of ZHENOLUTEN® and conventional therapy in
67% of cases normalized the menstrual cycle and helped reduce the astheno-neurotic manifestations
of the disease.

Effect of Zhenoluten®on the content of pituitary hormones in blood serum of Table 3


patients with ovarian wasting syndrome.

Indicator Norm Before Treatment After Treatment with After Treatment with
Conventional Drugs (Control Zhenoluten® (Primary
Group) Group)

FSH, (IU / ml) 1,5-45 114,6±7,8 87,2±5,4* 56,4±2,9*#

LH, (IU / ml) 2-17 47,3±2,6 38,6±3,9 28,5±2,1*#

Estradiol, (pmol / l) 110-734 51,1±2,6 68,3±3,1* 88,2±4,1*#

* p <0.05 - significant compared with the indicator before treatment;


# p <0.05 - significant compared with the indicator in patients of the control group.

Laboratory data indicate a trend towards normalization of the ratio of hormones FSH, LH, and estra-
diol (Table 3).
Analysis of this data allows us to conclude that ZHENOLUTEN® has a normalizing effect on cellular
metabolism in ovarian tissues, promotes the formation and maturation of follicles, and the restoration
of the reproductive system functions in women.
Thus, the results obtained indicate the therapeutic efficacy of ZHENOLUTEN® and the advisability
of its use in the complex treatment of patients of different ages with menopause and ovarian deple-
tion syndrome.
When using ZHENOLUTEN®, no side effects, complications, or drug dependence were revealed.
ZHENOLUTEN® can be used for therapeutic and prophylactic purposes in the form of a biologically
active food supplement combined with any means of symptomatic and pathogenetic therapy used to
treat menopausal syndrome and ovarian wasting syndrome.

CONCLUSION
Biologically active food supplement ZHENOLUTEN® has a normalizing effect on the functional ac-
tivity of ovarian cells.
ZHENOLUTEN® is well tolerated when taken orally, has no side effects, and can be used as a thera-
peutic and prophylactic biologically active food supplement.
ZHENOLUTEN® is recommended for use in patients with menopausal syndrome and ovarian deple-
tion syndrome orally with meals, 1-2 capsules 2 times a day for 30 days.
According to indications, a second course of treatment should be carried out after 3-6 months.

REFERENCES
1. Bodyazhina V.I., Smetnik V.P., Tumilovich L.G. Non-Operative Gynecology: A Guide for Physicians.
- M.: Medicine, 1990. -- 544 p.
2. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. - M.: the Universe, 1993. -- 398 p.
3. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
4. Geriatric manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.
5. Tepperman J., Tepperman H. Physiology of metabolism and the endocrine system: Translation from
English - M.: Mir, 1989. -- 656 p.
Zhenoluten®

RECOMMENDATIONS FOR USE


ZHENOLUTEN® is a complex of peptides obtained from the ovaries of young animals. The isolated
peptides have a selective effect on ovarian cells, normalize metabolism in ovarian cells, and regulate
the functions of the reproductive system in women.
In a clinical study, the effectiveness of ZHENOLUTEN® was established in the complex treatment of
patients with the climacteric syndrome, ovarian depletion syndrome, and to restore the functions of
the reproductive system in women after diseases of various origins under the influence of extreme
environmental factors, malnutrition, as well as aging.
It is recommended to take ZHENOLUTEN® 1-2 capsules or tablets 1-2 times a day with meals. The
duration of admission is 30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of:individual intolerance to the components, pregnancy, breastfeeding.
No side effectshave been identified when using ZHENOLUTEN®.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of ZHENOLUTEN®.
Expiration date: 3 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Libidon®

Report on the results of clinical studies of the


biologically active food supplement
Libidon®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Libidon®

Biologically active food supplement LIBIDON® contains a complex of low molecular weight peptides
with a molecular weight of up to 5000 Da, isolated from the tissues of the triceps muscle of young
animals - mature bulls.
LIBIDON® is available in the form of capsules with an active substance content of 10 mg.
LIBIDON® peptides regulate metabolic processes in the prostate gland cells, increase their reserve
capacity, have a beneficial effect on the adaptation processes of the body in extreme conditions, have
antioxidant properties, and regulate the processes of peroxidation in the tissues of the prostate. Ex-
perimental studies have shown that peptides have a tissue-specific effect on the cells of those tissues
from which they are isolated. This allows us to assume the effectiveness of the use of LIBIDON® to
restore the functions of the prostate gland in men of different ages with disorders of various origins.
Diseases of the prostate gland currently occupy an important place among urological pathology, tend to
increase the incidence, and acquire an ever-increasing social significance (1, 3). According to a number
of authors, more than 70% of men over the age of 50 suffer from prostate diseases, including benign
prostatic hyperplasia and oncological diseases. Thus, the search for new effective and safe agents for
preventing and treating prostate diseases is an urgent task.
In the conservative treatment of patients with prostate diseases, taking into account the pathoge-
netic mechanisms, the following traditional drugs of various directions of action are mainly used (2):
- Antibacterial and anti-inflammatory action - antibiotics and sulfa drugs;
- Normalization of microcirculation - trental, galidor, escuzan;
- Stimulation of metabolic processes - streptokinase, raveron;
- Antispasmodic action - no-shpa, baralgin;
- Normalization of the level of sex hormones - methyltestosterone, sustanon-250;
- Correction of immunopathological reactions - prodigiosan, pyrogenal, levamisole, tavegil, fenkarol.
- etc.

CLINICAL CHARACTERISTICS OF PATIENTS


A clinical study of the effectiveness of the use of LIBIDON®was carried out at the Medical Center of
the St. Petersburg Institute of Bioregulation and Gerontology in the period from March to November
2011.
Distribution of patients by nosological forms and age. Table 1

Diagnosis Age Number of Patients

Chronic prostatitis 38-49 28

Benign prostatic hyperplasia 51-65 20

Total: 48

* p <0.05 - significant compared with the indicator before treatment;


# p <0.05 - significant compared with the indicator in patients of the control group.

Clinical trials were carried out in 48 patients aged 38 to 65 years with a diagnosis of benign prostatic
hyperplasia (BPH) and chronic prostatitis (Table 1), who, in addition to conventional therapy, were
prescribed LIBIDON®: orally 1 capsule 2 times a day with meals for 30 days. The control groups
consisted of 22 similar patients who received only conventional treatment.

RESEARCH METHODS
The effectiveness of treatment was assessed based on the dynamics of patients’ complaints, general
clinical examination of blood and urine, biochemical blood study on the REFLOTRON apparatus
(Boehringer Mannheim, Germany), and blood coagulograms before and after the end of treatment.
Using the device «UROFLOUKOMPAKT» (Wiest, Germany), the maximum, average rate and time of
urination, the time to reach the maximum rate of urination, and the fluorometric index were assessed.
The degree of abdominal pressure during urination and the nature of the urine stream was expressed
Libidon®

in points from 1 to 5 (1 - the norm, 5 - the most significant changes in the indicator).
A palpation assessment of the prostate gland, a laboratory study of its secretion, and a more in-
depth analysis of the state of copulatory function were performed along with the studies mentioned
above. Ultrasound examination of the prostate was conducted using a portable ultrasound machine
(SHIMADZU, Japan).

RESEARCH RESULTS
When evaluating the treatment results with LIBIDON® for chronic prostatitis, the primary attention
was paid to clinical criteria. At the end of treatment, the pain completely disappeared in 64.0%
and significantly decreased in 32.7% of patients presenting corresponding complaints. In 3.3%
of patients, the treatment did not give the expected effect, and the dynamics of pain were not
observed.
Of the number of patients suffering from sexual dysfunction, 44.4% indicated their complete
recovery, and 41.8% noted an improvement. The positive effect of the drug was manifested in
improving the quality of erection, enhancing orgasms, and eliminating their pain. An increase in the
duration of intercourse was also noted. By the end of treatment, 37.1% of patients reported libido
recovery.
Pollakiuria (increased frequency of urination) altogether ceased to bother 87.5% of patients. The
need to urinate at night has disappeared.
Stranguria (difficulty urinating) ceased to bother 80.7% of patients, 15.9% noted an increase in the
urine stream and relief of the act of urination.
Summary information on the change in the act of urination in patients with chronic prostatitis after
treatment with LIBIDON® is presented in Table 2.
Palpation of the prostate gland through the rectum revealed a tendency to restore its size and
consistency after complex treatment with LIBIDON®. At the same time, areas of compaction
disappeared, and the study itself became painless. The observed decrease in the prostate gland
size, regarded as a result of a decrease in the edema of the interstitial tissue and indicating the
elimination of the activity of the inflammatory process in it, was also confirmed by the results of
ultrasound diagnostics.
Thanks to the restoration of the function of the prostate gland under the influence of LIBIDON®,
an improvement in the properties of its secretion was observed. This provided an increase in the
content of motile spermatozoa in the ejaculation by 11.8%. Decreased leukocytes confirmed a
decrease in the inflammatory process activity in the ejaculation, prostate secretions, and urine. At
the same time, a reduction in the content of cells of desquamated epithelium in the test material
was observed.
The dynamics of the study results in patients with prostate adenoma before and after the course of
treatment with LIBIDON® is presented in Table 3.

The influence of LIBIDON® on the state of urodynamics in patients Table 2


with chronic prostatitis
Indicator Before After Treatment with After Treatment with
Treatment Conventional Methods Libidon®

Average urination rate, (ml/sec) 17,3±1,2 19,8±1,6 23,5±2,4*

Maximum speed of 22,1±2,3 24,4±2,1 26,5±3,1


urination, (ml/sec)

Time to reach the maximum 3,6±0,2 2,8±0,1 1,5±0,1*


urination rate, (ml/sec)

* p <0.05 - significant compared with the indicator before treatment.


Libidon®

The influence of LIBIDON® on the state of urodynamicsin patients with benign Table 3
prostatic hyperplasia.

Indicator Before After Treatment with After Treatment with


Treatment Conventional Methods Libidon®

Time of urinary retention 4,6±0,3 3,2±0,1* 2,5±0,1*

Number of urinations:
- daytime 8,4±0,5 7,1±0,2* 6,3±0,1*
- nighttime 3,1±0,1 2,8+0,1 2,6+0,1

Abdominal pressure 3,2 2,8 2,4


(measured in points)

The nature of the stream of urine, (measured in points) 3,3 2,6* 2,3*

Average urination rate, (ml/sec) 11,3±1,2 14,2±1,4 17,5±1,6*

Maximum speed of 16,1±2,3 18,2±1,9 20,5±2,1


urination, (ml/sec)

Time to reach the maximum 6,6±0,3 5,3±0,1* 4,5±0,2*


urination rate, (ml/sec

* p <0.05 — significant compared to the values before treatment.

The condition of patients with BPH after treatment with LIBIDON® was characterized by an improve-
ment in subjective and objective indicators of urodynamics. An increase in libido was noted in 37.3%
of patients.
After treatment in patients with BPH stages I and II,uroflograms recorded the restoration of the basic
parameters of urination to normal values. At stage III of the disease, this was prevented by a decrease
in the elasticity of the bladder neck due to sclerotic changes in the tissue of the prostate gland. Still, a
noticeable increase in the urine stream was observed in such patients.
Thus, the results of this study indicate the therapeutic efficacy of LIBIDON® and its use in the complex
treatment of inflammatory diseases of the prostate and dysuric disorders.
LIBIDON® does not cause side effects, complications, or drug dependence and can be used for thera-
peutic and prophylactic purposes, including in combination with any means of symptomatic therapy used
in urological practice (antibacterial agents, antispasmodics, vascular and hormonal drugs, vitamins, etc.)
CONCLUSION
Biologically active food supplement LIBIDON® has a normalizing effect on the functional activity of
prostate cells.
LIBIDON® is well tolerated when taken orally, has no side effects, and can be used as a therapeutic
and prophylactic biologically active food supplement.
LIBIDON® is recommended to patients with chronic prostatitis and prostatic hyperplasia orally with
meals, 1-2 capsules 2 times a day for 30 days.
According to indications, a second course of treatment should be carried out after 3-6 months.

REFERENCES
1. Lyulko A.V., Yunda I.F., Sernyak P.S. and others.- Diseases of the prostate gland. - Kiev: Zdorov’ya,
1984. -- 280 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gam-
ta”, 1993.
3. Tkachuk V.N., Gorbachev A.G., Agulyansky L.I. Chronic prostatitis. - L .: Medicine, 1989 .-- 208 p.
Libidon®

RECOMMENDATIONS FOR USE


LIBIDON® is a complex of peptides obtained from the prostate gland of young animals. The isolated
peptides have a selective effect on prostate cells, normalize metabolism in prostate cells, and regulate
the functions of the reproductive system in men.
In a clinical study, the effectiveness of LIBIDON® in the complex treatment of patients with chronic
prostatitis and prostatic hyperplasia, for the restoration of the functions of the reproductive system
in men after diseases of various origins, under the influence of extreme environmental factors, mal-
nutrition, as well as aging, has been established.
It is recommended to take LIBIDON® 1-2 capsules or tablets 1-2 times a day with meals. The dura-
tion of admission is 30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of individual intolerance to the components.
Side effects when using LIBIDON® have not been identified.
It is recommended to store it in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of LIBIDON®.
Expiration date: 3 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Pielotax®

Report on the results of clinical studies of the


biologically active food supplement
Pielotax®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Pielotax®

Biologically active food supplement PIELOTAX® contains a complex of low molecular weight peptides
with a molecular weight of up to 5000 Da, isolated from kidney tissues of young animals - calves up
to 12 months of age or pigs.
PIELOTAX® is available in capsules with an active substance content of 10 mg.
PIELOTAX® peptides regulate metabolic processes in kidney tissue cells, increase the reserve ca-
pacity of the urinary system, have a beneficial effect on the body’s adaptation processes in extreme
conditions, and have antioxidant properties, regulating the processes of peroxidation in the kidneys.
Experimental studies have shown that peptides have a tissue-specific effect on the cells of those tis-
sues from which they are isolated. This allows us to assume the effectiveness of PIELOTAX® for the
restoration of kidney function in case of disorders of various origins.
Metabolic disorders, hypertension, infectious and autoimmune lesions, especially with age, often lead
to kidney damage (3).
Drug treatment of kidney disease includes the use of the following drugs (1, 2):
- Drugs of the 4-aminoquinoline range - delagil, plaquenil;
- Immunomodulators - thymalin, levamisole;
- Antihypertensive drugs;
- Vitamins C and E (antioxidants);
- etc.

The clinical study of PIELOTAX® was carried out at the Medical Center of the St. Petersburg Institute
of Bioregulation and Gerontology from February to August 2011.
Clinical trials of PIELOTAX® were carried out in patients with gouty nephropathy. A total of 42 patients
took part in the study. The distribution of patients by sex and age is presented in Table 1. Patients
with gouty nephropathy complained of recurrent pain in the joints. In connection with the prolonged
course of the disease in a number of patients, the inflammatory changes carried obliterated traits.
All patients previously received symptomatic and pathogenetic therapy for the disease, which con-
tributed to a temporary decrease in the severity of symptoms.
The patients were randomized into 2 groups - the control group (15 people) and the primary group
(27 people). Patients in the control group received only conventional therapy.
In addition to conventional therapy, patients of the primary group received PIELOTAX® orally 10-
15 minutes before meals, 1-2 capsules 3 times a day for 30 days, depending on the severity of the
pathological process.

Distribution of patients by diagnosis, sex and age. Table 1

Diagnosis Age Group Male Female Total

Gouty nephropathy 43-67 Control 9 6 15

42-68 Primary 19 8 27

Total: 28 14 42

RESEARCH METHODS
The patients’ complaints were assessed in dynamics, a general clinical examination of blood and urine, a
biochemical study of blood on the REFLOTRON apparatus (Boehringer Mannheim, Germany) were carried
out. Ultrasound examination of the kidneys was performed using an ultrasound machine (ALOKA, Japan).
Pielotax®

RESEARCH RESULTS
As a result of the studies, it was found that the use of PIELOTAX® helped to smooth the clinical
manifestations of gouty nephropathy in 78% of cases. However, the most revealing was the data
of laboratory research. While taking the drug, the activation of the metabolism of renal tissues was
observed, accompanied by an increase in the secretory function of the kidneys, which is reflected in
the dynamics of the biochemical parameters of the patients’ blood (Table 2).
As can be seen from the data shown in Table 2, in the control group, after treating patients with
conventional methods, an improvement in blood biochemical parameters, reflecting renal function,
was observed. However, these indicators did not reach normal values. In patients of the primary
group, blood biochemical parameters were close to normal values for men and women. Thus,
the residual nitrogen in the control group was on average 35.4 ± 0.8 mmol/l before treatment,
and after treatment - 30.5 ± 0.6 mmol/l (p <0.05), however, in patients of the primary group, this
indicator decreased to 27.1 ± 0.4 mmol/l, which is significantly lower compared to the indicator in
the control group and corresponds to the lower limit of the norm (28.6 mmol/l). The same trend
can be traced in the dynamics of the urea content in the blood: a decrease in the initially increased
indicator is observed in patients of both groups. However, in the primary group, the indicator was
9.2 ± 0.3 mmol/l, which brings its normal value closer to its average value (8.3 mmol/l). Changes in
the content of uric acid are also characteristic: in both men and women of the primary group, after
further use of the study drug, the indicators returned to normal - in men, the content of uric acid
decreased to 0.44 ± 0.02 mmol/l (in the control group, 0.56 ± 0.01 mmol/l, the norm is up to 0.50
mmol/l); in women of the primary group - up to 0.37 ± 0.03 mmol/l (in the control group 0.48 ±
0.02 mmol/l, the norm is up to 0.40 mmol/l).

Influence of PIELOTAX®on the biochemical parameters of the blood of Table 2


patients with gouty nephropathy.

Indicators Before Treatment After Treatment

Control Group Primary Group Control Group Primary Group

Residual nitrogen, (mmol/l) 35,4±0,8 34,1±0,7 30,5±0,6* 27,1±0,4*#

Residual nitrogen, (mmol/l) 14,7±0,5 13,8±0,6 11,8±0,5* 9,2±0,3*#

Uric acid, (mmol/l)


- women 0,57±0,01 0,55±0,02 0,48±0,02* 0,37±0,03*#
- men 0,75±0,03 0,78±0,04 0,56±0,01* 0,44±0,02*#

* - p <0.05 compared with the indicator in the same group before treatment.
# - p <0.05 compared to the same indicator in the control group

Thus, the results obtained indicate the therapeutic effectiveness of PIELOTAX®and the advisability
of its use in the complex treatment of patients with gouty nephropathy and other diseases associated
with impaired renal function.
PIELOTAX®does not cause side effects, complications, or drug dependence.
PIELOTAX®can be used for therapeutic and prophylactic purposes in the form of a biologically active
food supplement combined with any means of symptomatic and pathogenetic therapy used to treat
patients with gouty nephropathy and other kidney diseases.
Pielotax®

CONCLUSION
Biologically active food supplement PIELOTAX® has a normalizing effect on metabolism in kidney
tissues.
PIELOTAX® is well tolerated when administered orally. It has no side effects and can be widely used
as a therapeutic and prophylactic biologically active food supplement.
PIELOTAX® is recommended to patients with gouty nephropathy and other kidney diseases to
be administered orally 10-15 minutes before meals, 1-2 capsules 2-3 times a day for 15-30 days,
depending on the severity of the pathological process.
It is possible to repeat the course of treatment in 3-6 months.
It is advisable to recommend PIELOTAX® for therapeutic and prophylactic use and industrial production.

REFERENCES
1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. - M.: the Universe, 1993. -- 398 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
3. Geriatric manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.

RECOMMENDATIONS FOR USE


PIELOTAX®is a complex of peptides obtained from the kidneys of young animals. The isolated pep-
tides have a selective effect on various cells of kidney tissues, normalize metabolism in cells, and reg-
ulate their functions.
In the clinical study, the effectiveness of PIELOTAX®has been established for the complex resto-
ration of the functions of the urinary system after diseases of various origins, in pathological condi-
tions leading to impaired renal function, exposure to extreme environmental factors, malnutrition, as
well as aging.
Take 1-2 capsules or tablets of PIELOTAX®1-2 times a day with meals. The duration of admission is
30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of: individual intolerance to the components, pregnancy, or breastfeeding.
No side effectshave been identified when using PIELOTAX®.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of PIELOTAX®.
Expiration date: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center Chief Physician of the LLC «Medical Center of
of the St. Petersburg Institute of Bioregulation the St. Petersburg Institute of Bioregulation and
and Gerontology, SZO RAMS» for clinical work, Gerontology, SZO RAMS», Candidate of Medical
Candidate of Medical Sciences (PhD in Medical Sciences (PhD in Medical Science)
Science), Associate Professor
St. Petersburg Svetinorm®

Report on the results of clinical studies of the


biologically active food supplement
Svetinorm®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Svetinorm®

Biologically active food supplement SVETINORM® is a complex of low molecular weight peptides with
a molecular weight of up to 5000 Da, obtained from the liver of young animals - calves not older than
12 months of age or pigs. The isolated peptides have a tissue-specific effect on liver cells, restoring
metabolism and normalizing their functional activity.
SVETINORM® is available in tablets or capsules containing 10 mg of active peptides.
Clinical trials of SVETINORM® were carried out at the Medical Center of the St. Petersburg Institute
of Bioregulation and Gerontology, SZO RAMS, in patients with chronic hepatitis and cancer after a
course of radiation or radiation chemotherapy in the period from October 2005 to January 2006.
SVETINORM® was taken by patients orally 10-15 minutes before meals, 1-2 capsules 2 times a day
for 10-20 days, depending on the severity of the pathological process.
Chronic hepatitis is considered not an outcome of an acute infectious process but as a form of the
course of the infectious process (2, 3). Currently, there is an increase in the number of patients
with chronic liver lesions, which are prevalent mainly in people of working age. Adverse social and
environmental factors play a significant role in increased morbidity.
In the treatment of patients with chronic hepatitis, taking into account the pathogenetic mechanisms,
mainly the following conventional means are used (1):
- Drugs that improve the exchange of liver cells (hepatoprotectors) - Essentiale, Legalon, Sirepar;
- Stimulants of bile secretion - Liv-52;
- Vitamins of group B (B1, B6, B12), ascorbic acid;
- etc.

CLINICAL CHARACTERISTICS OF PATIENTS


Clinical trials were carried out in 47 patients with chronic hepatitis and cancer after a course of
chemotherapy, including 30 men and 17 women aged 35 to 68 years (Table 1). In addition to
conventional treatments, patients of the primary group received Svetinorm® 2 capsules 2 times a
day before meals for 15-20 days. The duration of the disease ranged from 3 to 10 years.
The control groups consisted of 38 similar patients prescribed only conventional drugs.

Distribution of patients by nosological forms, sex and age. Table 1

Diagnosis Age Male Female Total

Chronic persistent hepatitis 35-56 21 13 34

Condition after a course of chemotherapy in cancer 53-68 9 4 13


patients

Total: 30 17 47

Most patients complained of pain in the right hypochondrium, general weakness, and rapid fatigability.
In 73% of patients, dyspeptic disorders were noted. In 53% of patients, hyperbilirubinemia, an increase
in the level of alanine aminotransferase, an increase in the globulin fraction of blood proteins, mainly
due to the fraction of immunoglobulins M, were noted, which indicates a certain activity of the chronic
inflammatory process.

RESEARCH METHODS
Patients’ complaints were assessed subjectively in dynamics. A general clinical examination of blood
and urine, biochemical and immunological blood tests (determination of immunoglobulins according
to Mancini), and ultrasound examination of the liver were performed.
Svetinorm®

RESEARCH RESULTS
After treatment with SVETINORM®, most patients noted the disappearance of weakness, an increase
in appetite and performance. In 53% of patients, the intensity of pain syndrome significantly decreased.
Cancer patients noted an improvement in their well-being, a decrease in weakness, and decreased
intensity of dyspeptic disorders

Influence of SVETINORM® on the biochemical parameters of peripheral Table 2


blood of patients with chronic hepatitis.

Indicator Before After Treatment with After Treatment with


Treatment Conventional Means Svetinorm®

Cholesterol, (mmol/l) 4,6±0,2 5,2±0,3 5,0±0,4

Bilirubin, (μmol/l) 27,1±1,2 23,6±1,4 20,1±0,8*

AST, (mmol /h•l) 41,0±2,5 39,1±2,7 38,8±2,6

ALT, (mmol/h•l) 52,5±4,1 46,1±3,8* 43,5±3,5*

ƴ-HT, (mmol / h•l) 44,7±4,3 42,6±4,0 41,4±4,1

Triglycerides, (mmol/l) 2,3±0,1 2,1±0,4 1,7±0,6*

* P <0.05 - significant compared with the indicator before treatment.

When analyzing the effectiveness of SVETINORM®, particular attention was paid to assessing the
results of the biochemical studies characterizing the aminotransferase activity, pigment, and protein-
forming functions of the liver. Objectively, after the use of SVETINORM®, the stabilization of the
biochemical parameters was observed in most patients: the level of bilirubin, alanine aminotransferase
(Table 2). The study of peripheral blood immunoglobulins, an essential criterion for the inflammatory
process activity, after a course of treatment with SVETINORM®, showed a decrease in IgM level
(Table 3).

Influence of SVETINORM® on immunological parameters in patients with Table 3


chronic hepatitis.

Indicators Before After Treatment with After Treatment with Svetinorm®


Treatment Conventional Means

IgA, (g/l) 2,20±0,1 2,30±0,04 2,10±0,06

IgM, (g/l) 3,90±0,05 2,30±0,07* 1,60±0,04*

IgG, (g/l) 14,5±1,0 13,7±1,1 14,0±1,2

* P <0.05 - significant compared with the indicators before treatment.


Svetinorm®

RECOMMENDATIONS FOR USE


SVETINORM® is recommended to accelerate the recovery of liver function in acute or chronic liver
damage, in the treatment of antibiotics and other drugs that adversely affect the liver, malnutrition,
in cancer patients after radiation or chemotherapy, and when the body is exposed to various extreme
factors. Also, it is recommended for the elderly to maintain liver function.
It is recommended to take SVETINORM® 10-15 minutes before meals, 1-2 tablets or capsules 2-3
times a day for 15-20 days.
It is advisable to repeat the course in 3 - 6 months.

REFERENCES
1. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
2. Podymova S.D. Liver diseases. – M.: Medicine, 1984. – 480 p.
3. Rakhmanova A.G., Prigozhina V.K., Neverov V.A. Infectious diseases: Manual for general practitioners.
– M.-SPb.: Pub. “SSZ”, 1995. – 304 p.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Sigumir®

Report on the results of clinical studies of the


biologically active food supplement
Sigumir®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Sigumir®

Biologically active food supplement SIGUMIR® contains a complex of low molecular weight peptides
with a molecular weight of up to 5000 Da, isolated from the cartilage tissue of young animals - calves
up to 12 months of age or pigs.
SIGUMIR® is available in tablets or capsules with an active ingredient content of 10 mg.
Experimental studies have shown that peptides have a tissue-specific effect on the cells of those tis-
sues from which they are isolated. They improve the trophism of cartilage cells and have a regulatory
effect on its metabolic processes, reducing the risk of various lesions of the joints and spine. This sug-
gests the effectiveness of the use of SIGUMIR® to restore the function of cartilage tissue in inflam-
matory and dystrophic-degenerative diseases of the musculoskeletal system.
Clinical trials of SIGUMIR® were carried out at the Medical Center of the St. Petersburg Institute of
Bioregulation and Gerontology in patients with osteoarthritis of the joints, osteochondrosis of the
spine, and osteoporosis in the period from November 2005 to February 2006.
SIGUMIR® was administered to patients orally 10-15 minutes before meals, 1-3 capsules 2-3 times
a day for 30-45 days, depending on the severity of the pathological process.
The treatment and rehabilitation of patients with degenerative-dystrophic diseases of the joints and
spine, occurring with irreversible, progressive manifestations, is a complex problem that is most ur-
gent in geriatric practice (2, 3).
Drug therapy for degenerative-dystrophic diseases of the joints and spine includes the use of various
drugs of symptomatic and pathogenetic action (1):
- Analgesics and anti-inflammatory drugs (analgin, novocaine blockade, rheopyrin, indomethacin,
brufen);
- Antihistamines (diphenhydramine, pipolfen);
- Drugs that improve peripheral blood circulation (pachikarpin, platifillin);
- Biostimulants (rumalon, aloe, vitreous body, ATP);
- Enzyme medication (lidase, ronidase);
- Anabolic steroids (nerabol, retabolil);
- etc.

CLINICAL CHARACTERISTICS OF PATIENTS


Treatment with SIGUMIR® was carried out in 33 patients with diagnoses of osteoarthritis of the knee
joints (10 people, including 7 men, 3 women), osteochondrosis of the spine (15 people, including 6
men, 9 women), osteoporosis ( 8 women). The patients’ age ranged from 45 to 78 years.
The control group included 31 patients with similar diagnoses, gender, and age. The distribution of
patients by diagnosis, sex, and age is shown in Table 1.
Osteoporotic patients complained of frequent bone fractures arising from minor trauma or even for
no apparent reason.
The duration of the course of the disease ranged from 5 to 20 years. There were progressive dynam-
ics of the development of the pathological process.
In patients of the primary and control groups, the duration of the disease ranged from 5 to 20 years,
and there were progressive dynamics of the development of the pathological process.
All patients had previously received analgesics and anti-inflammatory drugs for a long time, the use
of which caused a short-term therapeutic effect, requiring an increase in the dose of drugs for the
course of treatment and their prolonged use.
Patients in the control group received treatment using conventional means. In addition to conven-
tional means, patients of the primary group were prescribed SIGUMIR® 2-3 capsules 2-3 times a day
before meals for 30-45 days.
Sigumir®

Distribution of patients by diagnosis, sex and age. Table 1

Diagnosis Age Male Female Total

Control Primary Control Primary Control Primary


Group Group Group Group Group Group

Knee osteoarthritis 59-78 6 7 3 3 9 10

Osteochondritis of the spine 45-69 7 6 8 9 15 15

Osteoporosis 45-65 - - 7 8 7 8

Total: 13 13 11 12 31 33

RESEARCH METHODS
To assess the effectiveness of the use of SIGUMIR®, we analyzed the dynamics of patients’ complaints
and objective indicators: general clinical examination of blood and urine, biochemical blood test, and
X-ray.

RESEARCH RESULTS
It should be noted that the radiology symptoms of degenerative-dystrophic diseases of the joints and the
spine are not only objective diagnostic criteria for the stage of development of the pathological process
but also have a great prognostic value in drug therapy.
It was found that the use of SIGUMIR® in patients with osteoarthritis of the knee joints contributed
to a decrease in pain syndrome and an increase in joint mobility in 68.5% of cases. At the same time,
pain symptoms disappeared almost entirely at the radiologically determined initial stages of the disease:
narrowing of the joint space between the patella and the thigh, lateral osteophytes of the patella, and
femoral condyle. No significant dynamics of radiological symptoms were observed during this period.
In patients in the advanced stage of arthrosis, a similar but less pronounced dynamics of subjective
indicators was observed. Since this stage of the disease was diagnosed in persons of the older age group,
such subjective sensations were characterized as very favorable.
In patients with osteochondrosis of the lumbar spine, the use of SIGUMIR® against the background of
complex therapy helped reduce pain in 53.7% of cases. A progressive course of the disease with age,
accompanied by characteristic X-ray symptoms (narrowing of the lumen between adjacent vertebral
bodies due to flattening of degeneratively altered intervertebral discs; the formation of anterior and
posterior osteophytes of the vertebral bodies, the presence of arthritic changes in the posterior and
lateral intervertebral joints in the form of narrowing of the crevices, unevenness development of
osteophytes along the edges of the articular ends; changes in the configuration of the intervertebral
foramen), contributed to the development of spondylosis and spondyloarthrosis and the formation of
neurodystrophic and neurovascular syndromes. These dynamics were most typical for middle-aged
people. In these cases, long-term (at least 45-60 days) use of SIGUMIR® smoothed out pain symptoms
arising from stress on the spine and lower extremities and increased the spine’s mobility.
In patients with osteoporosis, with prolonged use of the drug, the stabilization of metabolic processes in
the bone tissue was noted: the number of characteristic fractures decreased, the process of restoration
of the function of the musculoskeletal system was significantly accelerated, and the time spent in the
hospital decreased.
All patients showed a significant smoothing of the main symptoms of this group of diseases, characterized
by substantial conservatism.
Sigumir®

SIGUMIR® does not cause side effects, complications, or drug dependence.


Thus, the results of this study indicate the therapeutic efficacy of SIGUMIR® and the practicality of
its use in the complex treatment and prevention of degenerative-dystrophic diseases of the joints and
spine in combination with any means of symptomatic and pathogenetic therapy used to treat this group
of diseases (analgesics, anti-inflammatory, antihistamines, and vascular agents, biostimulants, enzyme
preparations, anabolic steroids, vitamins, etc.).

CONCLUSION
The biologically active food additive SIGUMIR® promotes the normalization of metabolic processes in
the cartilaginous tissue and slows down its involutive changes.
SIGUMIR® can be used for therapeutic and prophylactic purposes as a biologically active food supplement
combined with any means of symptomatic and pathogenetic therapy used to treat degenerative-
dystrophic diseases of the joints and spine - osteoarthritis, osteochondrosis, osteoporosis, etc.

REFERENCES
1. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
2. V.A. Nasonova, M.G. Astapenko Clinical Rheumatology: A Guide for Physicians. - M.: Medicine,
1989. -- 592 p.
3. Geriatric manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.

RECOMMENDATIONS FOR USE


A complex of peptides isolated from cartilage and bone tissues. The isolated peptides have a selec-
tive effect on various cells of cartilage and bone tissues, normalize cell metabolism, and regulate the
functions of the joints and spine.
In a clinical study, the effectiveness of Sigumir® was established for the complex restoration of the
functions of the musculoskeletal system after suffering diseases of various origins in pathological
conditions leading to dysfunction of cartilage and bone tissues, exposure to extreme environmental
factors, malnutrition, and also during aging.

SIGUMIR® is well tolerated by patients when taken orally, has no side effects, and can be widely used
as a therapeutic and prophylactic biologically active food supplement.
SIGUMIR® is recommended:
- To patients with osteoarthritis of the joints - orally 10-15 minutes before meals, 2 tablets or capsules
3 times a day for 45 days;
- To patients with osteochondrosis of the spine - orally 10-15 minutes before meals, 2 tablets or cap-
sules 3 times a day for 45 days;
- To patients with osteoporosis - orally 2 tablets or capsules 2 times a day 10-15 minutes before meals
for 30 days.
It is recommended to repeat the course of treatment in 3-6 months.
It is advisable to recommend SIGUMIR® for therapeutic and prophylactic use and industrial production.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center Chief Physician of the LLC «Medical Center of
of the St. Petersburg Institute of Bioregulation the St. Petersburg Institute of Bioregulation
and Gerontology, SZO RAMS» for clinical work, and Gerontology, SZO RAMS», Candidate of
Candidate of Medical Sciences (PhD in Medical Medical Sciences (PhD in Medical Science)
Science), Associate Professor
St. Petersburg Stamakort®

Report on the results of clinical studies of the


biologically active food supplement
Stamakort®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Stamakort®

Biologically active food supplement STAMAKORT® contains a complex of low molecular weight pep-
tides with a molecular weight of up to 5000 Da, isolated from the gastric mucosa tissues of young
animals - calves up to 12 months of age or pigs.
STAMAKORT® is available in capsules with an active substance content of 10 mg.
STAMAKORT® peptides regulate metabolic processes in the gastric mucosa cells, increase the reserve
capacity of the gastrointestinal tract, have a beneficial effect on the adaptation processes of the body
in extreme conditions, have antioxidant properties, and regulate the processes of peroxidation in the
tissues of the gastric mucosa. Experimental studies have shown that peptides have a tissue-specific
effect on the cells of those tissues from which they are isolated. This allows us to assume the effec-
tiveness of the use of STAMAKORT® to restore the functions of the gastrointestinal tract with dis-
orders of various origins.
Chronic inflammatory diseases of the stomach and duodenum and postoperative complications are
the cause of the formation of functional insufficiency and disorders of the secretory and motor func-
tions of various parts of the gastrointestinal tract (1, 2, 3), which significantly reduce the quality of life
of people of different ages.
Medical treatment of these diseases includes the use of the following drugs (2, 3):
- Enzyme drugs that improve digestion (pepsin, panzinorm, mezim-forte, festal);
- Bitters (centaury grass, wormwood herb, dandelion root);
- Ganglion blockers (hexonium, metacin);
- Multivitamins;
- Biostimulants (aloe);
- etc.
The clinical study of STAMAKORT® was carried out at the Medical Center of the St. Petersburg In-
stitute of Bioregulation and Gerontology from February to August 2011.
In clinical trials of STAMAKORT®, 47 patients with chronic gastritis took part, who complained of a
feeling of heaviness and fullness in the epigastric region, bloating, belching with food or air, rumbling
in the abdominal cavity, stool disturbance, and general weakness. At times the patients were disturbed
by a dull, aching pain in the epigastric region after eating. The distribution of patients by sex and age
is shown in Table 1.
All patients previously received symptomatic and pathogenetic therapy for these diseases.
The patients were randomized into 2 groups. The control group included 17 patients who received
conventional therapy.
In addition to conventional therapy, patients of the primary group (30 people) received STAMAKORT®
orally 10-15 minutes before meals, 1-2 capsules 3 times a day for 30 days, depending on the severity
of the pathological process.

Distribution of patients by sex and age. Table 1

Diagnosis Age Group Male Female Total

Chronic gastritis with secretory 36-72 Control 10 7 17


insufficiency
35-70 Primary 19 11 30

Total: 29 18 47

RESEARCH METHODS
The patients’ complaints were assessed in dynamics, a general clinical examination of blood and urine,
and a biochemical study of blood on the REFLOTRON apparatus (Boehringer Mannheim, Germany)
were carried out. Determination of the secretory function of the stomach and fibrogastroscopywere
carried out as well.
Stamakort®

RESEARCH RESULTS
As a result of the studies, it was found that the use of STAMAKORT® helped to smooth the clinical
manifestations of chronic gastritis in 86% of cases, and the most significant effect was observed in
persons of the older age group, in whom signs of atrophic changes in the gastric mucosa were noted
during the fibrogastroscopy.
The laboratory examination of gastric juice showed insufficiency of the secretory function of the stom-
ach in the examined patients of both groups before treatment (Table 2).
The indices of total acidity and free hydrochloric acid in patients of both groups were at the lower
limit of the norm before treatment, which was clinically manifested by symptoms of hypoacidity. Af-
ter treatment with conventional means in patients of the control group, the indicators of total acidity
and free hydrochloric acid increased, respectively, from 24.2 ± 2.1 mmol/l to 31.4 ± 2.4 mmol/l, and
in patients of the primary group - up to 37, 1 ± 1.8 mmol/l, which is significantly higher than in the
control group (p <0.05). The same trend was observed when studying the dynamics of changes in the
indicator of the content of free hydrochloric acid. As a result of the action of STAMAKORT®, there
was an optimization of indices of gastric secretory function in patients of the primary group since the
index of total acidity, and the content of free hydrochloric acid approached normal values.

Influence of STAMAKORT®on gastric secretory function in patients with Table 2


chronic gastritis.

Indicators Before Treatment After Treatment

Control Group Primary Group Control Group Primary Group

Total acidity on an empty stomach, (mmol/l) 24,2±2,1 22,6±1,7 31,4±2,4* 37,1±1,8*#

Free HCl, (mmol/l) 11,3±1,1 14,3±1,7 15,9±1,3* 19,2±1,5*

HCl flow rate, (mmol/h) 1,21±0,08 1,13±0,01 1,57±0,05 1,86±0,03

Free HCl flow rate, (mmol/h) 0,56±0,03 0,72±0,04 0,79±0,07 0,96±0,04

* - p <0.05 compared with the indicator in the same group before treatment.
# - p <0.05 compared to the same indicator in the control group.

When examining the contents of the gastric juice in patients of the primary group in the process of
taking STAMAKORT®, there was an increase in gastric acidity, a decrease in inflammatory changes in
the gastric mucosa, and a reduction in mucus and food debris in the test portions taken on an empty
stomach, which indicate an increase in the secretory and evacuation functions of the stomach.
Clinical patients noted a decrease in the manifestations of dyspeptic disorders, a decrease in pain syn-
drome, and improved well-being.
The normalization of digestion in patients with chronic disease is associated with the regulatory ef-
fect of STAMAKORT®, not only on the function of the gastric and duodenal mucosa cells but also by
stimulating the enzymatic activity of the duodenal contents.
Thus, the results obtained indicate the effectiveness of STAMAKORT® and the advisability of its use
in the complex treatment of chronic gastritis.
STAMAKORT® does not cause side effects, complications, or drug dependence.
STAMAKORT® can be used for therapeutic and prophylactic purposes in the form of a biologically
active food supplement and in combination with any means of symptomatic and pathogenetic thera-
py used to treat chronic gastritis.

CONCLUSION
Biologically active food additive STAMAKORT®has a normalizing effect on metabolism in the gastric
mucosa tissues.
Stamakort®

STAMAKORT® is well tolerated when taken orally, has no side effects, and can be widely used as a
therapeutic and prophylactic biologically active food supplement.
STAMAKORT® is recommended for oral administration in patients with chronic gastritis 10-15 min-
utes before meals, 1-2 capsules 2-3 times a day for 15-30 days, depending on the severity of the
pathological process.
It is recommended to carry out repeated courses of treatment in 3-6 months.

REFERENCES
1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. - M.: the Universe, 1993. -- 398 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO
“Gamta”, 1993.
3. Geriatric manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.

RECOMMENDATIONS FOR USE


STAMAKORT®is a complex of peptides obtained from the gastric mucosa of young animals. The iso-
lated peptides have a selective effect on various cells of the gastric mucosa tissues, normalize metab-
olism in the corresponding cells, and regulate their functions.
In the clinical study, the effectiveness of STAMAKORT®for the complex restoration of the functions
of the digestive system after diseases of various origins, in pathological conditions leading to dysfunc-
tion of the stomach, exposure to extreme environmental factors, malnutrition, as well as aging, has
been established.
Take 1-2 capsules or tablets of STAMAKORT®1-2 times a day with meals. The duration of admission
is 30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of: individual intolerance to the components, pregnancy, or breastfeeding.
No side effects when using STAMAKORT®have been identified.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of STAMAKORT®.
Expiration date: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Suprefort®

Report on the results of clinical studies of the


biologically active food supplement
Suprefort®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Suprefort®

Biologically active food supplement SUPREFORT® is a complex of low molecular weight peptides with
a molecular weight of up to 5000 Da, obtained from the pancreas of young animals - calves not older
than 12 months of age or pigs. The isolated peptides have a tissue-specific effect on the pancreas cells,
restoring metabolism and normalizing their functional activity.
SUPREFORT® is available in tablets or capsules containing 10 mg of active peptides.
SUPREFORT® was administered to patients orally 10-15 minutes before meals, 1-2 capsules 2 times a
day for 10-20 days, depending on the severity of the pathological process.
Clinical trials of SUPREFORT® were carried out at the Medical Center of the St. Petersburg Institute of
Bioregulation and Gerontology, SZO RAMS in patients with chronic pancreatitis in remission and pa-
tients with type II diabetes mellitus in the period from November 2005 to January 2006.
Dysregulation of physiological functions and pathological changes in the pancreas causes diseases with
digestive and metabolic disorders manifestations.
The consequence of a progressive inflammatory process in the pancreas is, as a rule, dystrophic pro-
cesses, accompanied by a violation of the formation and secretion of pancreatic digestive enzymes,
characteristic of chronic pancreatitis. In the presence of disorders of insulin secretion, the symptoms of
«secondary» diabetes develop.
Diabetes is one of the most common endocrine diseases: it affects about 1-2% of the world’s popula-
tion. In addition, there is almost the same number of patients with latent diabetes and genetically pre-
disposed to this disease. The manifestations of diabetes in each case represent an integrated reaction
to the combined action of numerous factors in different combinations (genetic predisposition, chemical
and infectious agents of the external environment, autoimmune processes, nutrition, physical activity,
psychological stress, etc.). The discovery of new syndromes (diabetes caused by the formation of an-
tibodies to insulin receptors; diabetes caused by a genetic defect in the structure of insulin, etc.) justi-
fies the constant need to supplement the existing classifications of the disease. The disease’s potential
latent and asymptomatic forms, occurring without clinical manifestations, draw particular attention to
prognosis, prevention, and treatment (1, 3, 6, 7, 8).
For the treatment of chronic pancreatitis, diet therapy and enzyme preparations (pancreatin, panzinorm),
and others are mainly used (5)
Treatment of diabetes without clinical manifestations includes diet therapy and herbal medicine (2, 4).

CLINICAL CHARACTERISTICS OF PATIENTS


The distribution of patients who took part in the study by sex and age is presented in Table 1. Treatment
with SUPREFORT® was carried out in 34 patients (18 men and 16 women) with diagnoses of «Chronic
pancreatitis,» latent form (12 people), and «Diabetes mellitus type II, latent form» (22 people). Patients
with chronic pancreatitis complained of loss of appetite, belching, flatulence, rumbling in the abdomen,
and stool disorders. By random distribution, two groups of patients were formed, equal in sex, age, di-
agnosis: the primary group included 12 patients (8 men, 4 women), the control group - 8 patients (4
men, 4 women).
Distribution of patients by diagnosis, sex and age.
Table 1
Diagnosis Age Male Female Total

Control Primary Control Primary Control Primary


Group Group Group Group Group Group

Chronic pancreatitis 39-68 4 8 4 4 8 12

Type II diabetes mellitus 42-64 6 10 11 12 17 22

Total: 10 18 15 16 25 34

Patients in the control group received conventional treatment. In addition to conventional drugs, patients
of the primary group were prescribed SUPREFORT® 1-2 capsules 2 times a day before meals for 15 days.
Suprefort®

Diabetes mellitus type II occurred in patients without any clinical manifestations and was diagnosed
based on an increase in glucose level in the peripheral blood, taking into account an unbalanced diet.
The control group consisted of 17 patients prescribed medication using conventional treatment. 22
patients included in the primary group, in addition to traditional therapy, including antihyperglycemic
agents, received 1 capsule of SUPREFORT® 2 times a day before meals for 15 days.

RESEARCH METHODS
The patients’ complaints were assessed in dynamics, a general clinical examination of blood and urine,
and a biochemical study of blood on the REFLOTRON apparatus (Boehringer Mannheim, Germany) were
carried out. The duodenal contents were examined. A glucose tolerance test was performed.

RESEARCH RESULTS
It was found that the use of SUPREFORT® in patients with chronic pancreatitis promoted an increase
in appetite and a decrease in the frequency of dyspeptic disorders.

Influence of SUPREFORT® on the activity of digestive enzymes in Table 2


patients with chronic pancreatitis.

Indicator Before Treatment After Treatment with Conventional After Treatment with
Means Suprefort®

Trypsin, (mmol/l) 2,14±0,09 2,72±0,12 2,9±0,1

α-amylase, kg / (h•l) 5,2±0,4 5,7±0,3 6,1±0,4

In a laboratory study of the duodenal contents, an initial decrease in the activity of pancreatic enzymes
was noted (Table 2). As a result of the use of SUPREFORT®, there was a tendency to an increase in the
activity of pancreatic enzymes, which correlated with an improvement in clinical symptoms.
In patients with type II diabetes mellitus, SUPREFORT® was used under the control of a glucose tolerance
test. After the sugar load, it was found that the patients had a characteristic glycemic curve. In addition
to the conventional treatment, patients of the primary group were prescribed SUPREFORT® 1 capsule
2 times a day before meals for 10 days. It was shown that after the use of SUPREFORT®, when the test
was performed in the second hour of the study, a gradual decrease in blood glucose levels was observed.
Normalization of blood glucose levels was achieved in all patients 5-10 days after starting the drug. None
of the patients received an increase in the dosage of antihyperglycemic drugs, 12 patients (54.5%) had
a reduced dose of conventional medications, and in 7 patients (31.8%), the blood glucose level did not
exceed normal values without the use of antidiabetic drugs. The indicators remained at the initial level
in 3 patients (13.6%). It should be noted that the indicator of glucose in the blood of patients of the
primary group stabilized during the next 2-3 months after the end of the course of treatment (Table 3).

Influence of SUPREFORT® on blood glucose after carbohydrate load in patients Table 3


with type II diabetes mellitus.

Blood glucose Control Group Primary Group


(mmol/l)
Before Treatment After Treatment Before Treatment After Treatment with
with Conventional Suprefort®
Methods

On an empty stomach 8,2±0,9 6,6±0,4* 7,9±1,1 5,8±0,3*

2 hours after glucose intake 12,7±0,4 9,4±0,5 11,6±0,3 7,0±0,8* **

* P <0.05 - significant compared with the indicator before treatment;


** P <0.05 - significant compared with the indicator in patients of the control group.
Suprefort®

CONCLUSION
Biologically active food supplement SUPREFORT® has a normalizing effect on the functional activity
of pancreatic cells.
SUPREFORT® is well tolerated when administered orally, has no side effects, and can be used as a ther-
apeutic and prophylactic biologically active food supplement in the complex treatment of pancreatic
dysfunction.
- To patients with chronic pancreatitis - orally 10-15 minutes before meals, 1-2 tablets or capsules 2
times a day for 15 days;
- To patients with diabetes mellitus - orally 10-15 minutes before meals, 1 tablet or capsule 2 times a
day for 15 days under the control of blood glucose.
It is advisable to repeat the course of treatment in 3-6 months

REFERENCES
1. Balabolkin M.I. Diabetes Mellitus / Endocrine Diseases / / Diagnosis and Treatment of Internal Dis-
eases: A Guide for Physicians. Ed. F.I. Komarova. - M.: Medicine, 1991. - T. 2. - S. 465-492.
2. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide for
Physicians. - M.: the Universe, 1993. -- 398 p.
3. Internal Diseases / Ed. A.S. Smetnev, V.G. Kukes. - M.: Medicine, 1982. -- 496 p.
4. Yordanov D., Nikolov P., Boychinov Asp. Phytotherapy. - Sofia: Medicine and Physical Education,
1972. -- 346 p.
5. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gam-
ta”, 1993.
6. Geriatric manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.
7. Tepperman J., Tepperman H. Physiology of metabolism and the endocrine system: Translation from
English - M. Mir, 1989. -- 656 p.

RECOMMENDATIONS FOR USE


A complex of peptides isolated from the pancreas. The isolated peptides have a selective effect on var-
ious cells of the pancreas, normalize metabolism in cells, and regulate the functions of the pancreas.
In a clinical study, the effectiveness of SUPREFORT® was established for the complex restoration of
pancreatic functions after past pancreatic diseases of various origins, in pathological conditions leading
to pancreatic dysfunction, exposure to extreme environmental factors, impaired carbohydrate metabo-
lism, malnutrition, and also during aging.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center Chief Physician of the LLC «Medical Center of
of the St. Petersburg Institute of Bioregulation the St. Petersburg Institute of Bioregulation
and Gerontology, SZO RAMS» for clinical work, and Gerontology, SZO RAMS», Candidate of
Candidate of Medical Sciences (PhD in Medical Medical Sciences (PhD in Medical Science)
Science), Associate Professor
St. Petersburg Taxorest®

Report on the results of clinical studies of the


biologically active food supplement
Taxorest®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Taxorest®

Biologically active food supplement TAXOREST® contains a complex of low molecular weight pep-
tides with a molecular weight of up to 5000 Da, isolated from the tissues of the bronchial mucosa of
young animals - calves not older than 12 months of age or pigs.
TAXOREST® is available in capsules with an active substance content of 10 mg.
TAXOREST®’s peptides regulate metabolic processes in the bronchial mucosa cells, increase their re-
serve capacity, have a beneficial effect on the adaptation processes of the body in extreme conditions,
have antioxidant properties, and regulate the processes of peroxidation in the tissues of the bronchial
mucosa. Experimental studies have shown that peptides have a tissue-specific effect on the cells of
those tissues from which they are isolated. This allows us to assume the effectiveness of the use of
TAXOREST® to restore the functions of the respiratory system in case of disorders of various origins,
including a decrease in the reserve capacity of the bronchi when aging.
Chronic bronchitis is a severe medical and social problem due to the high prevalence, growing inci-
dence, and substantial economic damage to society. Chronic bronchitis is the main form in the struc-
ture of chronic nonspecific lung diseases (3, 4).
Medical treatment of chronic bronchitis includes the use of the following drugs (1, 2):
- Antibiotics (penicillin, kanamycin, oleandomycin);
- Sulfa drugs (biseptol, madribone);
- Bronchodilators (aminophylline, ephedrine, salbutamol, phentolamine);
- Expectorants (bromhexine, thermopsis);
- Immunomodulators (thymalin, taktivin);
- Glucocorticoids (hydrocortisone, prednisolone, dexamethasone), etc.

CLINICAL CHARACTERISTICS OF PATIENTS


A clinical study of the effectiveness of TAXOREST® was carried out at the Medical Center of the St.
Petersburg Institute of Bioregulation and Gerontology in the period from April to November 2011.
The study involved 52 patients aged 35 to 73 years, including 35 men and 17 women, with a diagno-
sis of chronic bronchitis and remission phase, divided into 2 groups. In addition to the conventional
treatment, patients of the primary group received TAXOREST® 1 capsule 2 times a day with meals
for 30 days.
The control group included 21 people comparable in diagnosis, sex, and age with the patients of the
primary group. Patients in the control group received only conventional therapy.
Patients in both groups complained of coughing up phlegm, mainly in the morning, general weakness,
sweating, shortness of breath during physical exercises, recurrent attacks of suffocation, sleep distur-
bances, and headaches. All examined patients had severe smoking habits.

RESEARCH METHODS
General clinical examination of blood and urine, biochemical blood study using the REFLOTRON appa-
ratus (Boehringer Mannheim, Germany) were carried out. Also, radiography of the lungs, microscopic
examination of sputum, and analysis of the function of external respiration were performed. Patients’
complaints were assessed in dynamics.

RESEARCH RESULTS
It was found that the use of TAXOREST® in addition to conventional therapy in patients with chronic
bronchitis in 82% of cases contributed to an improvement in well-being, a decrease in the frequency
of coughing attacks, asthma attacks, and a decrease in the amount of sputum secreted. Positive dy-
namics of subjective indicators in the control group were observed in 57% of patients.
Auscultation of the lungs in dynamics showed a decrease in dry and buzzing wheezing.
During the use of TAXOREST®, a decrease in the microscopic structures of sputum was observed:
leukocytes, epithelial cells, Kurshman’s coils, which indicates a decrease in the inflammatory and bron-
chospastic manifestations of the disease.
Taxorest®

The study of the function of external respiration showed that against the background of treatment
with TAXOREST®, the indices of bronchial patency improved (Table 1).

The influence of TAXOREST® on the indicators of external respiration in Table 1


patients with chronic bronchitis.

Indicator Before Treatment After Treatment with After Treatment with


Conventional Methods Taxorest®

Lung vital capacity 3654,1 ±231,9 3876,5±215,4 4220,7 ±243,1*


(VC), ml

Total lung capacity (TLC), ml 4730,2±276,5 5075,4±211,6 5246,1±223,6

Expiratory forced vital capacity of the lungs 2767,8±134,7 3225,6±148,2 3940,5±123,6*


(EFVCL), ml

* - p <0.05 compared to the indicator before treatment.

The results of the study of the function of external respiration indicate a sufficiently compensated
pathological process in the lungs, but, at the same time, there are phenomena of impaired bronchial
patency, mainly due to spasm of small bronchioles. The use of TAXOREST® had a positive impact on
the dynamics of the development of this process.
Thus, the results of this study indicate the therapeutic efficacy of TAXOREST® and the practicality of
its use in the complex treatment of chronic bronchitis, including the bronchitis of smokers.
In the process of using TAXOREST®, no side effects, complications, contraindications, or drug
dependence were identified.
TAXOREST® can be used for therapeutic and prophylactic purposes in the form of a biologically active
food supplement and in combination with any means of symptomatic and pathogenetic therapy used
to treat chronic bronchitis.

CONCLUSION
Biologically active food additive TAXOREST® has a normalizing effect on the functional activity of
the bronchial mucosa cells.
TAXOREST® is well tolerated when taken orally, has no side effects, and can be used as a therapeutic
and prophylactic biologically active food supplement.

REFERENCES
1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. - M.: the Universe, 1993. -- 398 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
3. Paleev N.R., Tsarkova L.N., Borokhov A.I. Chronic nonspecific lung diseases. - M.: Medicine, 1985.
-- 240 p.
4. Tsarkova L.N., Ilchenko V.A. Chronic nonspecific lung diseases / Diagnostics and treatment of internal
diseases: A guide for doctors. Ed. F.I. Komarova. - M.: Medicine, 1991. - T. 2. - S. 106-250.
Taxorest®

RECOMMENDATIONS FOR USE


TAXOREST® is a complex of peptides obtained from the bronchial mucosa of young animals. The iso-
lated peptides have a selective effect on the bronchial mucosa cells, normalize their metabolism, and
regulate the functions of the respiratory system.
A clinical study established the effectiveness of TAXOREST® in the complex treatment of patients with
chronic bronchitis of various origins to restore the functions of the respiratory system after diseases of
multiple origins, under the influence of extreme environmental factors, malnutrition, as well as aging.
Instructions for TAXOREST®: take 1-2 capsules or tablets 1-2 times a day with meals. The duration
of admission is 30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of:individual intolerance to the components, pregnancy, breastfeeding.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Testoluten®

Report on the results of clinical studies of the


biologically active food supplement
Testoluten®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Testoluten®

The biologically active food supplement TESTOLUTEN® contains a complex of low molecular weight
peptides with a molecular weight of up to 5,000 Da, isolated from the tissues of the testes of young
animals - mature bulls.
TESTOLUTEN® is available in capsules with an active substance content of 10 mg.
TESTOLUTEN® peptides regulate metabolic processes in testicular cells, increase the reserve capac-
ity of the male reproductive system, have a beneficial effect on the adaptation processes of the body
in extreme conditions, and have antioxidant properties, regulating the processes of peroxidation in
testis tissues. Experimental studies have shown that peptides have a tissue-specific effect on the cells
of those tissues from which they are isolated. This allows us to assume the effectiveness of the use of
TESTOLUTEN® to restore the functions of the male reproductive system in case of its malfunctions
of various origins.
The climax is a transitional period of qualitative restructuring of the body in new age-related condi-
tions of the dynamic interaction of organs and systems to maintain the relative stability of homeo-
stasis. Essentially it is a physiological syndrome caused by age-related shifts in hormonal and general
metabolism and, above all, age-related extinction of the function of the gonads. In men, it occurs lat-
er than in women. It proceeds less noticeably and merges with the signs of old age. Symptoms of the
male physiological climax can be observed in different age groups and varying degrees of severity.
Changes in the functional state of the male reproductive glands play an important role for the male
body in this period. It is generally accepted that involutionary processes primarily affect the endocrine
function of the testicles.
The onset of atrophic processes in the interstitial tissue of the testicles with the involvement of glan-
dulocytes in the process can be detected already at the age of 30-40 years. At the age of 50-60 years
and older, the concentration of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testos-
terone, and estradiol ratios change significantly. Changes in the hormonal background and the associ-
ated restructuring of the mental and neurohumoral components of the copulatory cycle underlie the
extinction of the copulative function, which is manifested by a decrease in the frequency of sexual
intercourse, a reduction in libido, and weakening of erections. In this case, the increase in pathologi-
cal symptoms from the nervous, vascular and reproductive systems in men of the older age group are
accompanied by pathological male climax (2, 3). Medical treatment of the climax is necessary only for
those men in whom its manifestations significantly go beyond the physiological framework, leading to
a disorder of critical functional systems of the body. In such cases, treatment should be comprehen-
sive and include etiological, pathogenetic, and symptomatic components (1, 2, 3).
For the treatment of male climax, the following drugs are used:
- Hormonal drugs (methyltestosterone, testosterone propionate, sustanon-250, ambosex);
- Adaptogens (ginseng, extracts of Eleutherococcus, Leuzea, Rhodiolarosea, tinctures of aralia, zamani-
hi, saparal, pantocrine);
- Tranquilizers (elenium, seduxen, phenazepam, meprobamate, trioxazine);
- Antidepressants (clomipramine, melipramine);
- Vitamin therapy (vitamins B1, B6, B12);
- etc.

A clinical study of the effectiveness of TESTOLUTEN® was carried out at the Medical Center of the
St. Petersburg Institute of Bioregulation and Gerontology in the period from May to November 2011.
The clinical study involved 36 men aged 47 to 65 years with a diagnosis of male climax.
Patients complained of rapid fatigue, decreased physical and mental performance, weakened memo-
ry, emotional instability, increased sweating, irritability, and surges in blood pressure. Still, most men
paid particular attention to the appearance of sexual weakness.
Most of the patients did not previously seek medical help and independently took various medications
that help to level pathological reactions.
The patients were divided into 2 groups (Table 1). Patients in the control group (14 people) received
conventional therapy, excluding hormonal drugs.
Testoluten®

In addition to conventional therapy, patients in the primary group (22 people) received TESTOLUTEN®
1 capsule 2 times a day with meals for 30 days.

Distribution of patients by groups. Table 1

Diagnosis Control Group Primary Group

Age Number of Age Number of


Patients Patients

Male Climax 47-64 14 49-65 22

RESEARCH METHODS
Patients’ complaints were assessed in dynamics, and general clinical examination of blood and urine,
biochemical blood study using the REFLOTRON apparatus (Boehringer Mannheim, Germany) were
carried out. Using a radioimmunological method, the content of sex hormones in the blood serum
was determined. The radioactivity of the samples was counted on the «Tracor Analytic 1285» counter
(USA-Holland). In addition, palpation of the prostate gland, laboratory examinations of secretion and
ejaculation were performed.

RESEARCH RESULTS
The studies showed that in the examined patients, the manifestations of male climax result from
predominantly hormonal changes in the body, characteristic of this age group. The severity of these
manifestations in younger people is also due to various unfavorable environmental and occupational
factors. An increase in blood glucose was noted in some patients, which probably indicates a “break-
down” of the insulin regulation system.
Changes in the concentration of sex hormones in the blood were characteristic (Table 2).
In almost all patients, genetic changes in the prostate gland were determined by palpation.
The use of TESTOLUTEN® against the background of complex treatment helped improve the general
well-being of patients and increase libido.
It is imperative to note that TESTOLUTEN® had a regulatory effect on the content of sex hormones
in the blood (Table 2). As can be seen from the data in Table 2, before treatment, the ratio of sex hor-
mones was disrupted in all patients, while the content of all hormones, including testosterone, was at
the lower limit of the norm. The use of TESTOLUTEN® led to a significant increase in the content of
luteinizing hormone (LH) and follicle-stimulating hormone (FSH) compared with the indicators both
before treatment and in patients in the control group who received conventional therapy without
hormonal drugs.
It is important to note that as a result of the use of TESTOLUTEN®, the testosterone content in the
blood of patients of the primary group significantly increased compared to the indicator before treat-
ment. No significant increase in testosterone content was observed in the patient’s blood in the con-
trol group.
Testoluten®

Effect of TESTOLUTEN®on the content of sex hormones in the peripheral Table 2


bloodin patients with male climax.

Indicator Norm Before Treatment After Treatment After Treatment with


with Conventional Testoluten®
Methods

LH, mU/ml 4,0-11,0 3,12±0,07 3,88±0,05* 4,65±0,07**

FSH, mU/ml 1,5-7,0 1,67±0,05 2,15±0,05* 2,96±0,09**

Testosterone, mU/ml 2,0-10,0 3,2±0,2 3,5±0,4 5,4±0,12*, **

* - p <0.05 compared with the indicator before treatment;


** - p <0.05 compared with the indicator in the control group.

As can be seen from the data in Table 2, the content of LH, FSH, and testosterone in the blood serum
of patients in the control group increased compared to the indicators before treatment; however, it
remained at the lower limit of the norm. In patients of the primary group, the testosterone content
increased to normal values - 5.4 ± 0.12 ng/ml, which correlated with a significant improvement in
well-being and the leveling of psychophysiological disorders - emotional instability, irritability, memory
impairment, decreased physical and mental performance, as well as vegetative violations - increased
sweating, headaches, and surges in blood pressure.
All patients of the primary group who took TESTOLUTEN® noted an increase in libido.
Microscopic examination of the ejaculate was indicative. There was an increase in the number of
sperm and their mobility, a decrease in the pathological forms of sperm, and a decrease in the number
ofleukocytes.
Thus, the results of this study indicate the therapeutic efficacy of TESTOLUTEN®and the advisability
of its use in the complex treatment of male climax.
When using TESTOLUTEN®, no side effects were detected, no complications and drug dependence
were registered.
TESTOLUTEN®can be used for therapeutic and prophylactic purposes in the form of a biologically
active food supplement combined with any means of etiological, symptomatic, and pathogenetic
therapy used to treat male climax.

CONCLUSION
The biologically active food additive TESTOLUTEN® has a regulating effect on the functional activity
of testis cells and helps to normalize reproductive function in men.
TESTOLUTEN® is well tolerated when taken orally, has no side effects, and can be used as a therapeutic
and prophylactic biologically active food supplement.
TESTOLUTEN® is recommended for use: to patients with male climax - orally 10-15 minutes before
meals, 1 capsule 2 times a day for 30 days.
According to indications, a second course of treatment should be carried out after 3-6 months.
It is advisable to recommend TESTOLUTEN® for therapeutic and prophylactic use and industrial
production.

REFERENCES
1. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
2. Guide to Andrology / Ed. O. L. Tiktinsky. - L.: Medicine, 1990. -- 416 p.
3. Sexopathology: A Handbook / Ed. G.S. Vasilchenko. - M.: Medicine, 1990. -- 576 p
Testoluten®

RECOMMENDATIONS FOR USE


TESTOLUTEN® is a complex of peptides obtained from the testes of young animals. The isolated pep-
tides have a selective effect on testicular cells, normalize cell metabolism, and regulate the functions
of the reproductive system in men.
In the clinical study, the effectiveness of TESTOLUTEN® was established for the complex restoration
of the functions of the reproductive system in men after diseases of various origins, in pathological
conditions leading to impaired reproductive function in men, exposure to extreme environmental fac-
tors, malnutrition, as well as aging.

It is recommended to take TESTOLUTEN® 1-2 capsules or tablets 1-2 times a day with meals. The
duration of admission is 30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of individual intolerance to the components.
No side effects have been identified when using TESTOLUTEN®.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of TESTOLUTEN®.
Expiration date: 3 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Thyreogen®

Report on the results of clinical studies of the


biologically active food supplement
Thyreogen®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Thyreogen®

The biologically active food supplement THYREOGEN® is a complex of low molecular weight peptides
with a molecular weight of up to 5000 Da, obtained from the thyroid gland of young animals - calves
not older than 12 months of age or pigs. The isolated peptides have a tissue-specific effect on thyroid
cells, restoring metabolism and normalizing their functional activity.
THYREOGEN® is produced in tablets or capsules containing 10 mg of active peptides.
THYREOGEN® was administered to patients orally 10-15 minutes before meals, 1-2 capsules 2 times
a day for 20 days, depending on the severity of the pathological process.
Clinical trials of THYREOGEN® were carried out at the Medical Center of the St. Petersburg Institute
of Bioregulation and Gerontology, SZO RAMS, in patients with primary hypothyroidism in the period
from November 2005 to January 2006.
Primary hypothyroidism is one of the age-related disorders of the thyroid gland. In the pathogenesis
of primary hypothyroidism, a change in the gland tissue or inhibition of the synthesis of thyroid hor-
mones due to infectious diseases, trauma, or spontaneous destruction of the thyroid gland comes to
the fore (3, 4).
Drug treatment of primary hypothyroidism includes the use of the following drugs (1, 2):
- Thyroid hormones - thyroidin, thyroxine, triiodothyronine;
- Vitamins B6, B12;
- etc.

CLINICAL CHARACTERISTICS OF PATIENTS


The study involved 25 patients with primary hypothyroidism, including 11 men and 14 women aged
56 to 67 years. The control group consisted of 19 patients, including 7 men and 12 women. Patients
in both groups complained of rapid fatigue, drowsiness, memory impairment, frequent headaches, and
dizziness. In most cases, signs of thyroid atrophy were detected by palpation.
All patients previously received symptomatic therapy for the clinical manifestations of this disease.
Patients in the control group were prescribed conventional means. In addition to conventional drugs,
patients of the primary group received THYREOGEN® 1-2 capsules 2 times a day before meals for
20 days.

RESEARCH METHODS
The patients’ complaints were assessed in dynamics, a general clinical examination of blood and urine,
and a biochemical study of blood on the REFLOTRON apparatus (Boehringer Mannheim, Germany)
were carried out. Ultrasound examination of the thyroid gland was performed using an ultrasound
machine (ALOKA, Japan), electrocardiography - using a CARDIOTEST EK-51 apparatus (Hellinge, Ger-
many).
The content of hormones T3 and T4 in blood serum was determined by radioimmunoassay. The ra-
dioactivity of the samples was counted on a Tracor Analytic 1285 counter (USA-Holland).

RESEARCH RESULTS
As a result of the studies, it was found that the use of THYREOGEN® contributed to the improve-
ment of the clinical manifestations of the disease in 78% of cases, and the most significant effect was
observed in persons of the older age group with pronounced signs of thyroid atrophy. While taking
THYREOGEN®, the patients noted increased working capacity, decreased frequency and intensity of
headaches, and decreased pain in the heart region.
Thyreogen®

Influence of THYREOGEN® on the level of thyroid hormones in blood Table 1


serum in patients with primary hypothyroidism.

Indicators Before Treatment After Treatment with Conventional After Treatment with
Means Thyreogen®

Т3, (nmol/l) 0,38±0,03 1,12±0,06 1,58±0,07*

Т4, (nmol/l) 38,8±5,4 55,1±4,3 87,5±6,2*

* P <0.05 - significant compared with the indicator in the control group patients.

In the study of objective indicators, normalization of ECG parameters was observed. Attention is drawn
to the fact that the indicators of the secretory function of the thyroid gland remained at the achieved
level for 3-5 months after the course of treatment with the use of THYREOGEN®. The restoration
of the level of thyroid hormones within the physiological norm was noted (Table 1), which indicates a
stabilizing effect of the drug on the cellular metabolism of the gland and a regulatory effect on met-
abolic processes.
Thus, the obtained results of a clinical study of the drug indicate the effectiveness and appropriate-
ness of the use of THYREOGEN® in the complex treatment and prevention of thyroid dysfunctions
of various origins.
Clinical study of THYREOGEN® revealed no side effects or contraindications. The drug does not cause
complications or drug dependence.
The studied ready-made form of THYREOGEN® is convenient for inpatient, outpatient, and at-home
use.
THYREOGEN® can be used for therapeutic and prophylactic purposes in the form of a biologically
active food supplement as an adjuvant in combination with any means of symptomatic and patho-
genetic therapy used to treat diseases caused by dysfunction of the thyroid gland of various origins.

CONCLUSION
The biologically active food supplement THYREOGEN® has a normalizing effect on the metabolism
of thyroid cells.
THYREOGEN® is well tolerated by patients when taken orally, has no side effects, has no contraindi-
cations, and can be used as a therapeutic and prophylactic biologically active food supplement.

REFERENCES
1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. - M.: the Universe, 1993. -- 398 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gam-
ta”, 1993.
3. Geriatric manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.
4. Tepperman J., Tepperman H. Physiology of metabolism and the endocrine system: Translation from
English - M.: Mir, 1989. -- 656 p.
Thyreogen®

RECOMMENDATIONS FOR USE


THYREOGEN® is recommended to restore thyroid function in acute and chronic thyroid lesions. As a
prophylactic agent, it is advisable to use in areas endemic to thyroid diseases. It is also recommended
for the elderly to maintain thyroid function.
The drug is taken 10-15 minutes before meals, 1-2 tablets or capsules 2 times a day for 20 days.
It is recommended to repeat the course of treatment in 3-6 months.
It is advisable to recommend THYREOGEN® for therapeutic and prophylactic use and industrial pro-
duction.
Store in a dry place protected from light at a temperature of +2 to +25 oC.
Release form: 20 or 60 capsules of 0.2 g.
Expiration date: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Cerluten®

Report on the results of clinical studies of the


biologically active food supplement
Cerluten®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Cerluten®

Biologically active food supplement CERLUTEN® contains a complex of low molecular weight peptides
with a molecular weight of up to 5000 Da, isolated from the brain tissue of young animals - calves up
to 12 months of age or pigs.
CERLUTEN® is available in capsule form with an active ingredient content of 10 mg.
CERLUTEN® peptides regulate metabolic processes in brain cells, increase the brain’s reserve capac-
ity, have a beneficial effect on the adaptation processes of the body in extreme conditions, have an-
tioxidant properties, and regulate the processes of peroxidation in the cerebral cortex. Experimental
studies have shown that peptides have a tissue-specific effect on the cells of those tissues from which
they are isolated. This allows us to assume the effectiveness of the use of CERLUTEN® to restore the
functions of the central nervous system in case of disorders of various origins.
Treatment of diseases of the central nervous system is of particular relevance since they entail a vio-
lation of social adaptation and disability of patients (2).
Currently, in the treatment of patients with diseases of the central nervous system, taking into account
the pathogenetic mechanisms, the following traditional therapeutic agents of various directions of
action are mainly used (1, 3):
- Influence on metabolism and integrative functions of the brain - cerebrolysin, piracetam, encepha-
lolysate;
- Normalization of cerebral and systemic circulation - stugeron, cavinton;
- Relief of psychopathological manifestations - meridin, amitriptyline;
- Correction of changes in the bioelectric activity of the brain - phenobarbital, Konvulex;
- Impact on liquorodynamic disturbances - veroshpiron, furosemide;
- Prevention and inhibition of the development of adhesions - aloe, lidase;
- Correction of immunopathological reactions - levamisole, tavegil.
Clinical trials of CERLUTEN® were carried out in the period from October 2005 to February 2006 at
the Medical Center of the St. Petersburg Institute of Bioregulation and Gerontology, SZO RAMS, in
48 patients with various diseases of the central nervous system: long-term consequences of traumatic
brain injury (the duration of the trauma was from 1 to 10 years), conditions after a stroke, vascular en-
cephalopathy, and decreased mental performance, memory, and attention. In addition to conventional
drugs, patients of the primary group received CERLUTEN® 1-2 capsules 2-3 times a day before meals
for 10-20 days, depending on the severity of the pathological process. The distribution of patients by
nosological forms, sex, and age is shown in Table 1.
The control group consisted of 37 similar patients who received only conventional treatment.
All patients had previously received drugs of symptomatic and pathogenetic action, with the use of
which a short-term therapeutic effect was noted, requiring an increase in the dose of drugs for the
course of treatment and their prolonged use.
Cerluten®

Distribution of patients by nosological forms, sex and age. Table 1

Diagnosis Age Total: Total: Total:

Control Primary Control Primary Control Primary


Group Group Group Group Group Group

Long-term consequences of 32-58 5 8 2 2 7 10


traumatic brain injury

Conditions after a stroke 51-68 4 4 4 5 8 9

Vascular encephalopathy 52-73 5 6 7 11 12 17

Manifestations of reduced mental 43-65 6 7 4 5 10 12


performance, memory, and
attention

Total: 20 25 17 23 37 48

RESEARCH METHODS
The effectiveness of CERLUTEN® was assessed by the dynamics of subjective indicators and objec-
tively using the methods of correction test and electroencephalography (EEG).

RESEARCH RESULTS
After using CERLUTEN® in patients of the primary group, an excellent clinical result was observed in
64.6% of cases, satisfactory - in 22.9%, no positive effect - in 12.5% of cases (in the control group -
Table 2). There was no negative effect from CERLUTEN® on the condition of the patients.

The efficacy of CERLUTEN® in patients with diseases of the central nervous Table 2
system.

Treatment Results Patient Group

Treatment Using Conventional Means Treatment Using CERLUTEN®

Abs. % Abs. %

Good 10 27,0 31 64,6*

Satisfactory 15 40,5 11 22,9

Unsatisfactory 12 32,5 6 12,5*

Total: 37 100 48 100

* P <0.05 compared with the indicator in patients after treatment with conventional means.

When comparing the subjective indicators of the state of patients before and after the use of CER-
LUTEN®, it was found that the number of health complaints decreased by 2-3 times. Patients noted
an improvement in memory, intelligence, a decrease in the intensity and duration of headaches, the
appearance of emotional balance, volitional qualities, and a sense of rest after a night’s sleep (Table 3).
Cerluten®

In patients with the consequences of traumatic brain injury and stroke, there was a moderate re-
gression of focal symptoms, improved speech function with motor and sensory aphasia, and de-
creased muscle spasticity.
Comparative assessment of the influence of CERLUTEN® and other treatment methods on the
integral function of the brain - attention and bioelectrical activity of the brain were studied using a
corrective test and electroencephalography, respectively.

Influence of CERLUTEN® on the subjective indicators of the health Table 3


status of patients.

Indicator Before Treatment, % After Treatment using After Treatment using


Conventional Means, % Cerluten®

Headaches 76,6 47,2# 34,1#

Sleep disturbance 54,9 34,0# 24,3#

Emotional lability 75,8 43,0# 21,4*#

Memory impairment 54,5 45,2 28,5*#

Absent-mindedness 48,7 43,9 14,6*#

Fast fatiguability 72,0 53,2# 32,4*#

#
P <0.05 compared with the indicator in patients before treatment;
* P <0.05 compared with the indicator in patients after treatment with conventional means..

Influence of CERLUTEN® on the dynamics of indicators of performing the Table 4


correction test by patients with diseases of the central nervous system.

Examined group Quantity of viewed characters Quantity of mistakes

Healthy 1835,2±83,7 7,15±1,01

Patients before treatment 1143,7±75,4 18,12±0,93

Patients after treatment with conventional means 1573,8±67,5* 11,1±0,86*

Patients after treatment with CERLUTEN®


1682,6± 62,8*# 8,67± 0,96*#

* Р<0.05 compared with the indicator in the group of patients before treatment;
#
P<0.05 compared with the indicator in the group of patients after treatment with conventional means.
Cerluten®

The results of performing a correction test by patients after treatment by various methods are pre-
sented in Table 4. The best results were obtained in the primary group patients when analyzing the
dynamics of performing the correction test before and after treatment compared to patients in the
control group. As can be seen from the table, in patients after treatment with CERLUTEN®, the num-
ber of viewed signs significantly increased, and the number of errors decreased. This was expressed in
the absence of sharp fluctuations in the number of viewed characters for equal periods, the presence
of a period of «workability» by the middle of the task, and a gradual decrease in the curve by the end
of the task, which indicates greater stability of attention after treatment.
To assess the effect of CERLUTEN® on the bioelectrical activity of the brain, a visual analysis of EEGs
was performed with their distribution by type and the calculation of the alpha index before and after
treatment. EEG was performed selectively in patients with the most pronounced manifestations of
pathological processes. The research results are presented in Table 5.

The influence of CERLUTEN® on the characteristics of the types of Table 5


electroencephalograms in patients with diseases of the central nervous system.

Surveyed Group Type of EEG

III IV V

Before After Before After Before After


Treatment Treatment Treatment Treatment Treatment Treatment

After Treatment with Conventional 9 7 11 9 13 9


Means

After Treatment with Cerluten® 11 7 10 6 15 7

Before treatment, pathological (III, IV, V) types of EEG prevailed in the examined patients in different
groups. Type III EEG was characterized by the presence of a so-called non-dominant curve at a low
amplitude level (no higher than 30-35 μV), the presence of irregular alpha activity, or even its absence.
The IV type of EEG was characterized by a highly emphasized regularity of rhythms, blurring of zonal
differences. The V type of EEG was characterized by irregular slow activity with an amplitude above
35 μV, sharp waves, paroxysmal discharges.
The most pronounced changes in the brain’s bioelectric activity were observed in patients after treat-
ment with CERLUTEN®. First of all, this was manifested on the EEG in a clearer modulation and res-
toration of zonal differences in the alpha rhythm, a weakening of the severity of irritative processes,
in some cases - the disappearance of paroxysmal discharges.
Influence of CERLUTEN® on the dynamics of changes in the alpha-index in Table 6
patients with diseases of the central nervous system.

Examined Group Alpha Index

Before Treatment After Treatment

Healthy 55,1±3,9 -

Patients Treated with Conventional Means 33,6±3,7 41,3±4,2

Patients Treated with Cerluten® 34,0±4,1 47,9±3,7*#

* Р<0.05 compared with the indicator in the group of patients before treatment;
#
P<0.05 compared with the indicator in the group of patients after treatment with conventional means.
Cerluten®

In addition to visual EEG assessment, the alpha index was calculated in patients before and after treat-
ment (Table 6). It was found that under the influence of the treatment, there was a significant increase
in the alpha index in the patients of the study groups. The value of the alpha index was significantly
higher in the group of patients after treatment with CERLUTEN® as compared to the values in other
groups. However, the degree of change in the alpha index in patients receiving different treatments
was not the same.

CONCLUSION
Based on the data obtained, it is legitimate to conclude that the inclusion of reserve capacities of the
cerebral cortex with the help of CERLUTEN® improves the integral functions of the brain.
Thus, the clinical study results indicate the effectiveness and feasibility of using CERLUTEN® in the
complex treatment and prevention of diseases of the central nervous system of various origins.
CERLUTEN® does not cause side effects, complications, or drug dependence; clinical trials have iden-
tified no contraindications.
CERLUTEN®can be used for therapeutic and prophylactic purposes, combined with any means of
symptomatic therapy used in neurological practice (vascular, nootropic, absorbable, anticonvulsant,
vitamins, etc.).

REFERENCES
1. Kovalev G.V. Nootropic medicines. – Volgograd: Nizh.-Volzh. Publishing house, 1990. – 368 p.
2. Treatment of nervous diseases: Translated from English/ Edited by V.K.Viderholt. – M.: Medicine,
1984. – 560 p.
3. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gam-
ta”, 1993.

RECOMMENDATIONS FOR USE


CERLUTEN® is recommended to accelerate the recovery of brain functions after traumatic brain in-
jury, strokes, intellectual-mnestic disorders, exposure of the body to various extreme factors. It is also
recommended for the elderly to maintain mental performance.
CERLUTEN® is recommended to be taken 10-15 minutes before meals, 1-3 tablets or capsules 2-3
times a day for 10-20 days.
A second course is advised in 3 - 6 months.
There were no contraindications or side effects observed when using CERLUTEN®.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center Chief Physician of the LLC «Medical Center of
of the St. Petersburg Institute of Bioregulation the St. Petersburg Institute of Bioregulation
and Gerontology, SZO RAMS» for clinical work, and Gerontology, SZO RAMS», Candidate of
Candidate of Medical Sciences (PhD in Medical Medical Sciences (PhD in Medical Science)
Science), Associate Professor
St. Petersburg Chelohart®

Report on the results of clinical studies of the


biologically active food supplement
Chelohart®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Chelohart®

Biologically active food supplement CHELOHART® contains a complex of low molecular weight pep-
tides with a molecular weight of up to 5000 Da, isolated from the tissues of the heart of young ani-
mals - calves not older than 12 months of age or pigs.
CHELOHART® is available in capsules with an active substance content of 10 mg.
CHELOHART®’s peptides regulate metabolic processes in myocardial cells, increase the reserve ca-
pacity of myocardiocytes, have a beneficial effect on the adaptation processes of the body in extreme
conditions, and have antioxidant properties, regulating the processes of peroxidation in the myocardi-
um. Experimental studies have shown that peptides have a tissue-specific effect on the cells of those
tissues from which they are isolated. This allows us to assume the effectiveness of using CHELOHART®
to restore the functions of the heart in case of disorders of various origins.
Disorders of myocardial metabolism associated with oxygen deficiency underlie the development of
various forms of ischemic heart disease, is a common link in the pathogenesis of cardiomyopathies and
causes various cardiac disorders. The pathological process is based on a violation of the correspondence
between the heart’s need for blood supply and the functioning of the vascular system. Insufficient
blood supply to the myocardium is most often caused by atherosclerosis of the coronary vessels, one
of the most common age-related pathologies (1). Of particular concern to clinicians in recent decades
is the emergence of this age-related pathology in people of an increasingly young age, which leads to
the «rejuvenation» of myocardial infarction and an increase in the risk of developing its complications.
Ischemic heart disease is one of the most common causes of disability of patients and mortality among
the population of developed countries.
In the conservative treatment of patients with coronary heart disease, taking into account the patho-
genetic mechanisms, the following traditional therapeutic agents of various directions of action are
mainly used (1, 2):
- Vasodilators (nitroglycerin, nitrong, erinit);
- Calcium antagonists (verapamil, fenigidin);
- β-blockers (anaprilin, trazikor);
- Drugs that weaken adrenergic effects on the heart (cordaron);
- etc.

CLINICAL CHARACTERISTICS OF PATIENTS


A clinical study of the effectiveness of using CHELOHART® was carried out at the Medical Center of
the St. Petersburg Institute of Bioregulation and Gerontology from May to November 2011.
The clinical study involved 32 patients with ischemic heart disease - exertional angina of functional
class I and II - aged 46 to 72 years, including 18 men and 14 women. Disease duration ranged from
2 to 9 years.
Patients complained of rapid fatigability, decreased performance, weakness, tinnitus, dizziness, palpita-
tions, shortness of breath, recurrent pain in the heart, limited physical activity, and the onset of chest
pain attacks with characteristic irradiation to the left shoulder, left arm, and interscapular space. 19
patients (59.4%) diagnosed with exertional angina pectoris of the Ist class noted the development of
seizures only with great physical activity; the attacks were quickly stopped after the use of nitroglyc-
erin. In 10 patients (31.2%) diagnosed with exertional angina pectoris of the IInd class, pain attacks
behind the sternum occurred when walking at a distance of more than 500 m and climbing stairs. At
the same time, the patients noted a gradual increase in the frequency of attacks, which required an
increase in the dose of nitro drugs.
On the electrocardiogram, an objective examination in 26 patients (81.2%) revealed signs of impaired
coronary circulation during stress tests: a decrease in the S-T segment, a smoothed or negative T wave
in the standard and corresponding chest areas.
Analysis of the general clinical and biochemical blood tests did not reveal significant deviations from
normal values in each age group.
The patients were divided into 2 groups. The primary group included 22 patients, including 14 men
aged 46 to 64 years old and 8 women aged 51 to 72 years old, who, in addition to conventional meth-
Chelohart®

ods of treatment, were prescribed a course of CHELOHART®, 1 capsule 2 times a day with meals for
30 days.
The control group consisted of 10 patients (6 men aged 47 to 66 years and 4 women aged 50 to 69
years) who were prescribed only conventional treatment: long-acting nitrates, β-blockers, corinfar,
corvalol, motherwort tincture, and other sedatives (2, 3).

RESEARCH METHODS
The study of the effectiveness of the use of CHELOHART® was carried out based on generally accept-
ed research methods. Patients’ complaints were assessed in dynamics, general clinical and biochemical
blood tests, ultrasound examination of the heart, electrocardiography, a dosed exercise test on a bicycle
ergometer were carried out according to the method of step-by-step increasing intermittent activity.

RESEARCH RESULTS
The study results of the dynamics of changes in subjective indicators showed that in patients taking
CHELOHART®, the number of complaints about the general condition, shortness of breath, recurring
pain in the heart, and a feeling of rapid heartbeat decreased. The frequency and duration of angina
attacks significantly reduced. In 56% of patients, it was possible to reduce by half the daily dose of
nitrates of prolonged action against the background of a persistent decrease in the attacks of chest
pain in comparison with the initial level before treatment (Table 1).

Dynamics of subjective indicators in patients with coronary heart disease. Table 1

Complaints Patient Groups

After treatment with conventional means, After treatment with CHELOHART®, abs. (%)
abs. (%)

Improvement Without Improvement Without


Improvements Improvements

Recurrent pain in the heart region 4 (40%) 6 (60%) 15 (68,2%)* 7 (31,8%)*

Dyspnea 6 (60%) 4 (40%) 16 (72,7%)* 6 (27,3%)*

Weakness 7 (70%) 3 (30%) 16 (72,7%)* 6 (27,3%)*

Dizziness 6 (60%) 4 (40%) 12 (54,5%) 10 (45,5%)

Headaches 5 (50%) 5 (50%) 15 (68,2%)* 7 (31,8%)*

Noise in ears 5 (50%) 5 (50%) 14 (63,6%) 8 (36,4%)

Palpitations 6 (60%) 4 (40%) 17 (77,3%)* 5 (22,7%)*

* p <0.05 compared with the indicator in patients after treatment with conventional means.

The study of the dynamics of changes in mineral metabolism showed that in patients of both groups,
the potassium content in the blood plasma and calcium in the blood serum increased, approaching
normal values. There was no significant difference in indicators in patients of the primary and control
groups. However, the indicators after treatment were better in patients of the primary group who took
CHELOHART®than in patients in the control group. The magnesium content in the blood serum re-
mained within the normal range before and after treatment in patients of both groups (Table 2).
Chelohart®

Dynamics of changes in the indicators of mineral metabolism in the blood of Table 2


patients with coronary heart disease.

Indicator Norm Patients Treated with Conventional Patients who additionally received
Means Chelohart®

Before After Treatment Before After Treatment


Treatment Treatment

Potassium, mmol/l 3,4-5,3 3,13±0,6 3,48±0,4 3,10±0,4 3,52±0,5

Calcium, mmol/l 2,3-2,75 2,22±0,03 2,36±0,06 2,23±0,05 2,41±0,06

Magnesium, mmol/l 0,7-1,2 0,83±0,04 0,88±0,06 0,84±0,07 0,90±0,05

According to veloergometry data, the appearance of an attack of angina pectoris at the height of activity
after using CHELOHART® was observed reliably 1.9 times less often than before treatment, while in
patients of the control group - only 1.4 times (Table 3). After complex treatment with CHELOHART®,
54.5% of patients achieved a submaximal heart rate (HR) at the height of the threshold activity, while
in the control group - only 40% (before treatment - 21.9% of patients in both groups).
The tolerance assessment was carried out according to the threshold power value and the total amount
of work performed. As an indicator of positive antianginal treatment, tolerance to physical activity
was significantly higher in patients of the primary group after taking CHELOHART® compared with
indicators before treatment. However, the difference with indicators in patients in the control group
was insignificant.
To assess the efficiency of the cardiovascular system, the energy expenditure index was calculated.
A 1.6-fold decrease in the index after using CHELOHART® testified to a more economical expendi-
ture of energy reserves of the heart due to a decrease in myocardial oxygen demand during work (in
patients of the control group - by a factor of 1.3), which was reflected in a significant increase in the
index of maximum oxygen consumption by 16% in patients of the primary group (in the control group
- by 11%) compared with the indicator before treatment.

Dynamics of veloergometry indicators in patients with ischemic heart Table 3


disease.

Indicator Before Treatment After Treatment with After Treatment with


Conventional Means Chelohart®

The frequency of angina attacks,% 68,8 50* 36,4*#

Achievement of submaximal heart rate,%


21,9 40* 54,5 *#

Veloergometry threshold power, W/min 96,9±4,6 115,2±5,4 119,3±4,6*

Total work, kgm 2830±118 3457±110* 3673±119*

Energy cost index, units 15,8±1,4 11,9±2,4* 9,6±2,1*

Maximum oxygen consumption index, units 1,3±0,03 1,44±0,05* 1,49±0,04*

* p <0.05 compared with the indicator in patients before treatment;


#
p <0.05 compared with the indicator in patients after treatment with conventional means.
Chelohart®

CONCLUSION
Thus, as a result of the study, it was found that CHELOHART® has a pronounced effect on the con-
tractile function of the myocardium in patients with ischemic heart disease. An increase in patients’
tolerance to stress tests indicates the anti-ischemic effect of the drug and an improvement in mineral
metabolism indicators - a positive impact on metabolic processes in myocardial cells. In addition, we
observed a significant decrease in the index of energy costs due to an increase in the index of max-
imum oxygen consumption.
When conducting a clinical study of CHELOHART®in the elderly, no side effects, complications, or
drug dependence were observed. Do not use the product in case of individual intolerance to its com-
ponents.
Thus, the results of the study indicate the advisability of including CHELOHART® in the complex treat-
ment of patients with angina pectoris of the I-II functional classes, as well as its use for the prevention
of age-related pathology of the cardiovascular system, which should be carried out in courses of 1-2
capsules 2 times a day during 30 days. The course should be repeated 2-3 times a year.

REFERENCES
1. O. V. Korkushko- Age-related changes in the autonomic regulation of the heart rate in healthy el-
derly and senile people / O.V. Korkushko, V.B. Shatilo, G.M. Butenko // Physiol. zhurn. - 1988. - Issue.
34, No. 1. - S. 12-17.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gam-
ta”, 1993.
3. Metelitsa V.I. - Cardiologist’s Guide to Clinical Pharmacology. - M .: Medicine, 1980 .-- 304 p

RECOMMENDATIONS FOR USE


CHELOHART® is a complex of peptides obtained from the heart of young animals. The isolated pep-
tides have a selective effect on myocardial cells, normalize metabolism in myocardiocytes, and regu-
late the functions of the heart.
In a clinical study, the effectiveness of CHELOHART® was established in the complex treatment of
patients with cardiovascular pathology, including ischemic heart disease, for the restoration of myo-
cardial functions after diseases of various origins, under the influence of extreme environmental fac-
tors, malnutrition, as well as aging.
Take1-2 capsules or tablets of CHELOHART® 1-2 times a day with meals. Duration of admission is
30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of individual intolerance to the components, pregnancy, breastfeeding.
No side effectswere observed when using CHELOHART®.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of CHELOHART®.
Expiration date: 3 years from the date of manufacture.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center Chief Physician of the LLC «Medical Center of
of the St. Petersburg Institute of Bioregulation the St. Petersburg Institute of Bioregulation
and Gerontology, SZO RAMS» for clinical work, and Gerontology, SZO RAMS», Candidate of
Candidate of Medical Sciences (PhD in Medical Medical Sciences (PhD in Medical Science)
Science), Associate Professor
St. Petersburg Chitomur®

Report on the results of clinical studies of the


biologically active food supplement
Chitomur®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Chitomur®

Biologically active food supplement CHITOMUR® contains a complex of low molecular weight pep-
tides with a molecular weight of up to 5000 Da, isolated from the tissues of the bladder wall of young
animals - calves notolder than 12 months of age or pigs.
CHITOMUR® is available in capsules with an active substance content of 10 mg.
Experimental studies have shown that peptides have a tissue-specific effect on the cells of those tis-
sues from which they are isolated. CHITOMUR® peptides regulate metabolic processes in the bladder
wall cells, increase their reserve capacity, have a beneficial effect on the body’s adaptation processes
in extreme conditions, have antioxidant properties, and regulate the processes of peroxidation in the
tissues of the bladder wall. This allows us to assume the effectiveness of the use of CHITOMUR® to
restore the functions of the bladder in case of disorders of various origins.
Among the diseases most common in the elderly, the pathology of the bladder and urinary system
stands out, significantly impairing the quality of life of patients and aggravating the course of concom-
itant pathology. With age, the number of patients with various disorders of the lower urinary tract
function increases significantly, especially in the case of an overactive bladder (OAB). The diagnosis
is made without any hormonal, metabolic, or other apparent diseases (urinary tract infection, bladder
cancer, prostate adenoma, etc.) that can cause the symptoms.
The risk of overactive bladder syndrome increases with age. The critical age is over 60 - among older
people of this age, the prevalence of OAB is at its maximum. The increased risk of OAB for men is ex-
plained, in addition, by benign prostatic hyperplasia, signs of which are present to one degree or an-
other in about half of men aged 60+ years. Nevertheless, the absence of hyperplasia does not exclude
the presence of age-related changes in the bladder, which are almost identical in men and women.
It is believed that the postmenopausal period is also associated with an increased risk of develop-
ing OAB. More than 60% of postmenopausal women suffer from urinary dysfunction. However, the
role of sex hormones is not clear. The results of the use of hormone replacement therapy in these
patients are ambiguous, and instead of improvement, it can lead to a worsening of OAB symptoms.
Thus, a number of anatomical and physiological changes accompanying aging may predispose to the
development of OAB symptoms. Regardless, urinary incontinence should not be considered a natural
sign of aging. In addition, specific functional impairments such as limited mobility, dysfunction of the
upper limbs, and decreased vision can aggravate the course of OAB. It should be kept in mind that
pharmacological drugs used for concomitant diseases can also play a role. For example, diuretics can
significantly increase urinary frequency and mimic OAB symptoms.
Treatment of dysfunction of the bladder depends on the etiology of the pathological condition. In
chronic cystitis, antibiotic therapy is prescribed; with detrusor dysfunction, drugs of the atropine
group are prescribed; in case of neurogenic dysfunction of the bladder, M-anticholinergics (oxybutin,
tolterodine, darifenacin) are prescribed.

CLINICAL CHARACTERISTICS OF PATIENTS


A clinical study of the effectiveness of the use of CHITOMUR® was carried out at the Medical Center
of the St. Petersburg Institute of Bioregulation and Gerontology in the period from March to Novem-
ber 2011. The study involved 28 men aged 45 to 62 with a diagnosis of benign prostatic hyperplasia
(BPH) and 31 women aged 48 to 56 with a diagnosis of overactive bladder (OAB). All patients com-
plained of dysfunction of urination.
Chitomur®

Distribution of patients by nosological forms and age. Table 1

Diagnosis Age Number of Patients

Control Group Primary Group

Benign prostatic hyperplasia 45-62

Overactive bladder 48-56 9 22

Total: 19 40

* p <0.05 - significant compared to the indicator before treatment.

In addition to conventional means, patients of the primary groups (18 men and 22 women) were pre-
scribed CHITOMUR® 1 capsule 2 times a day with meals for 30 days. Patients in the control groups
(10 men and 9 women) received only conventional treatment. The distribution of patients by groups
is shown in Table 1.
The effectiveness of the use of CHITOMUR®was assessed based on the dynamics of complaints of
patients, general clinical examination of blood and urine, the biochemical study of blood, the degree
of abdominal pressure during urination, and the nature of the urine stream, fluorometric index.

RESEARCH RESULTS
The results of a clinical study of CHITOMUR® showed that pollakiuria (increased frequency of uri-
nation) altogether ceased to bother 88.3% of patients with BPH. In 93.2% of patients, the need for
nocturnal urination disappeared. Stranguria (difficulty urinating) ceased to bother 74.8% of patients,
26.7% of patients noted an increase in the urine stream and relief during the act of urination.
The dynamics of the study results in patients with BPH before and after the course of treatment with
CHITOMUR® is presented in Table 2.

Influence of CHITOMUR® on the state of urodynamics in patients Table 2


with benign prostatic hyperplasia.

Indicator Before After Treatment with Conventional After Treatment with


Treatment Methods Chitomur®

Time of urinary retention 4,5±0,6 3,4±0,4* 2,2±0,3*

Number of urinations:
- in the daytime 8,7±0,2 7,2±0,3* 6,3±0,1*
- in nighttime 3,7±0,3 2,9+0,2 2,0+0,4

Abdominal pressure, (points) 3,2 2,7 2,3

The nature of the stream of urine, (points) 3,4 2,5* 2,2*

Average urination rate, (ml/s) 13,5±1,3 15,1±1,6 19,4±1,4*

Maximum speed of urination, (ml/s) 17,2±1,8 19,1±1,5 21,4±1,6

Maximum speed of urination, (ml/s) 6,4±0,1 5,4±0,2* 4,4±0,4*

* p <0.05 - significant compared to the indicator before treatment.


Chitomur®

The condition of patients with BPH after treatment with CHITOMUR® was characterized by an im-
provement in subjective and objective indicators of urodynamics.
It should be noted that uroflograms recorded after treatment in patients with BPH stages I and II
showed the restoration of the basic parameters of urination to normal values. At stage III of the dis-
ease, this was prevented by a decrease in the elasticity of the bladder neck due to sclerotic changes
in the tissue of the prostate gland. Still, a noticeable increase in the urine stream was observed in
such patients.
The patients’ assessment of their bladder condition significantly improved. In women with climacteric
syndrome, accompanied by an overactive bladder, the use of CHITOMUR® achieved a 38% reduction
in urgency and incontinence episodes by 43%. The degree of discomfort due to imperative symptoms
decreased 1.8 times, the degree of anxiety decreased by 57%, and satisfaction with treatment reached
78%. Thus, according to the patients’ self-esteem, the decrease in anxiety caused by the symptoms
of urinary dysfunction is 1.8 times, comes ahead of the very positive dynamics of these symptoms,
which indicates a predominant improvement in the quality of life of women as a result of treatment.
A month after the course of treatment using CHITOMUR®, all patients retained the improvement in
symptoms. After discontinuation of the drug, the bladder capacity increased by 10-20% with various
urges to urinate, which is explained by a decrease in detrusor ischemia, which plays a significant role
in the pathogenesis of OAB.
Thus, the results of this study indicate the therapeutic efficacy of CHITOMUR® and the practicality
of its use in the complex treatment of dysuric disorders of various origins, including in diseases of the
prostate gland in men and women with symptoms of an overactive bladder.
CHITOMUR® does not cause side effects, complications, or drug dependence and can be used for
therapeutic and prophylactic purposes, combined with any means of symptomatic therapy used in
urological practice (antibacterial agents, antispasmodics, vascular and hormonal drugs, vitamins, etc.)

CONCLUSION
Biologically active food supplement CHITOMUR® has a regulating effect on the functional activity of
the cells of the wall and detrusor cells of the bladder and helps normalize urination function.
CHITOMUR®is well tolerated when taken orally, has no side effects, and can be used as a therapeutic
and prophylactic biologically active food supplement.
CHITOMUR®is recommended for patients with impaired urination function of various origins - oral-
ly during meals, 1-2 capsules or tablets 2 times a day for 30 days. It is recommended to repeat the
course of treatment in 3-6 months.

REFERENCES
1. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gam-
ta”, 1993.
2. Guide to Andrology / Ed. O. L. Tiktinsky. - L.: Medicine, 1990. -- 416 p.
3. Sexopathology: A Handbook / Ed. G.S. Vasilchenko. - M.: Medicine, 1990. -- 576 p.
Chitomur®

RECOMMENDATIONS FOR USE


CHITOMUR® is a complex of peptides obtained from the bladder wall of young animals. The isolated
peptides have a selective effect on the cells of the bladder wall, normalize their metabolism, and reg-
ulate the functions of the bladder.
In a clinical study, the effectiveness of CHITOMUR® was determined in the complex treatment of
patients with dysfunction of urination of various origins, including in men with chronic prostatitis and
prostatic hyperplasia and women with overactive bladder syndrome, to restore the functions of the
bladder after past diseases of various origins, with exposure to extreme environmental factors, mal-
nutrition, and aging.
Take 1-2 capsules or tablets of CHITOMUR® 1-2 times a day with meals. Duration of admission is 30
days. It is advisable to repeat the course in 4-6 months.
Do not use in case of individual intolerance to the components, pregnancy, breastfeeding.
No side effects have been identified when using CHITOMUR®.
Store it in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets each containing 10 mg ofCHITOMUR®.
Expiration date: 3 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Endoluten®

Report on the results of clinical studies of the


biologically active food supplement
Endoluten®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Endoluten®

Biologically active food supplement ENDOLUTEN®contains a complex of low molecular weight pep-
tides with a molecular weight of up to 5000 Da, isolated from the pineal gland tissues of young ani-
mals - calves up to 12 months age or pigs.
ENDOLUTEN® is available in capsules with an active substance content of 10 mg.
ENDOLUTEN®’s peptides regulate metabolic processes in neuroendocrine cells of various tissues, in-
cluding the pineal gland, increasing the neuroendocrine system’s reserve capacity, having a beneficial
effect on the adaptation processes of the body in extreme conditions, and have antioxidant proper-
ties, which regulate the processes of peroxidation in various tissues. Experimental studies have shown
that peptides have a tissue-specific effect on the cells of those tissues from which they are isolated.
This allows us to assume the effectiveness of the use of ENDOLUTEN® for the restoration of neuro-
endocrine regulation in case of disorders of various origins.
According to experimental data, ENDOLUTEN® contributes to the normalization of neuroendocrine
regulation of the body’s main functions.
It is known that the age-related decrease in the functional activity of the pineal gland causes a dis-
turbance of the mechanisms of interaction of the nervous, endocrine, and immune systems and con-
tributes to the development of various diseases and pathological conditions. The impact of extreme
environmental, climatic-geographical, professional, and psycho-emotional factors on the human body
leads to neuroendocrine and immunological disorders that cause maladjustment disorders and psy-
chosomatic diseases (3, 4, 5, 6).
The medical treatment of these diseases and pathological conditions includes the use of a wide vari-
ety of drugs, depending on the symptoms of the disease. However, the correction of these disorders
is based on the prescription of certain medications (1, 2):
- Adaptogens (ginseng, extracts of Eleutherococcus, Leuzea, Rhodiolarosea, tinctures of aralia, zamani-
hi, saparal, pantocrine);
- Peptide immunomodulators (thymalin, taktivin, thymogen, myelopid);
- Pineal gland hormone - melatonin;
- Pineal gland peptides - epithalamin;
- Multivitamins;
- etc.
However, drugs have side effects and cannot be prescribed to prevent the listed pathological condi-
tions. In this regard, developing new effective and safe means for prevention and increasing the ef-
fectiveness of treating patients with pathological conditions associated with impaired neuroendocrine
regulation is an urgent problem.
Clinical trials of ENDOLUTEN® were carried out in 163 patients (including 48 men, 115 women)
with dyshormonal myocardial dystrophy, physiogenic asthenia, and climacteric syndrome of mild and
moderate severity in women, as well as in cancer patients after courses of radiation and chemother-
apy, treated at the St. Petersburg Medical Center of the Institute of Bioregulation and Gerontology,
SZO RAMS from January to August 2011. The distribution of patients by nosological forms, sex, and
age is presented in Table 1.
Endoluten®

Distribution of patients by nosological forms, sex and age. Table 1

Diagnosis Age Group Male Female Total

Dyshormonal myocardial dystrophy 40-59 Control - 10 10

Primary - 18 18

Physiogenic asthenia 18-42 Control 9 - 9

Primary 14 - 14

Conditions after radiation and chemotherapy in 48-76 Control 11 18 29


cancer patients
Primary 14 26 40

Severe manifestations of climacteric syndrome 42-63 Control - 16 16

Primary - 27 27

Total: 48 115 163

The patients were randomized into 2 groups for each nosological form: control groups consisted of
64 people who received conventional treatment for their diseases (1, 2). Patients receiving hormone
replacement therapy were not included in the study.
In addition to the conventional treatment, patients of the primary groups were prescribed ENDO-
LUTEN® 1-3 capsules before meals 2-3 times a day for 15-30 days, depending on the severity of the
pathological process.

RESEARCH METHODS
The study of the effectiveness of the use of ENDOLUTEN® was carried out based on generally accept-
ed research methods. Patients’ complaints were assessed in dynamics, general clinical examination of
blood and urine, biochemical blood test, and electrocardiographic study were conducted. Peripheral
blood lymphocytes’ number and functional activity were assessed using immunological methods. The
content of hormones (FSH and LH) in blood serum was determined by radioimmunoassay. A correc-
tion test and Luscher’s test were used to assess psychophysiological parameters.

RESEARCH RESULTS
Negative manifestations of the climacteric period significantly reduce the working capacity of wom-
en of the most working-age. Therefore, the problem of finding new effective means that can reduce
or completely neutralize pathological conditions in women in the postmenopausal period, preserving
their health and high quality of life, is of particular relevance.
Endoluten®

Influence of ENDOLUTEN®on the content of pituitary hormones in blood serum Table 2


of patients with dyshormonal myocardial dystrophy.
Indicator Norm Before Treatment After Treatment with After Treatment with
Conventional Methods Endoluten® (Primary Group)
(Control Group)

FSH, (IU/ml) 1,5-45 89,3±3,5 71,6±6,3* 46,8±3,9*#

LH, (IU/ml) 2-17 28,1±1,9 25,7±2,4 16,4±1,4*#

Estradiol, (pmol/l) 110-734 65,4±5,2 79,1±4,2* 101,3±7,2*#

* p <0.05 - statistically significant compared with the indicator before treatment.


# p <0.05 - statistically significant in comparison with the indicator in patients of the control group.

In the process of using ENDOLUTEN® in patients with dyshormonal myocardial dystrophy, an im-
provement in the subjective indicators of the disease was noted, which was manifested in a decrease
in pain attacks in the heart area, an increase in working capacity, and a normalization of the psy-
choemotional state.
While taking ENDOLUTEN®, there was a positive dynamics of the ECG. The study of the level of
hormones in the blood serum of the patients of the primary group revealed a decrease in the initially
elevated FSH content from 89.3 ± 3.5 lU/ml to 46.8 ± 3.9 lU/ml with a norm of 1.5-45 lU/ml, and in
patients of the control group only up to 71.6 ± 6.3 lU/ml, which is significantly less than the indicator
before treatment, but considerably higher than the norm (Table 2). The same tendency was found in
the dynamics of changes in the LH content: in the patients of the primary group, under the influence
of ENDOLUTEN®, the indicator decreased to a normal value, while in the control group, it signifi-
cantly decreased compared to the indicator before treatment, but remained substantially higher than
the norm. The estradiol content, initially reduced considerably in patients of both groups, increased
from 65.4 ± 5.2 pmol/l to 101.3 ± 7.2 pmol/l and approached the normal value (110-734 pmol/l). In
contrast, in the control group patients, this indicator increased only to 79.1 ± 4.2 pmol/l.
The study made it possible to reveal the corrective effect of ENDOLUTEN® on hormonal imbalance,
contributing to the normalization of metabolism in myocardial tissues, which correlated with an im-
provement in the clinical picture of the disease.
The same tendencies in the normalization of the hormonal status were observed in patients with mild
and moderate climacteric syndrome: under the influence of ENDOLUTEN®, the balance of pituitary
hormones was restored, which correlated with the leveling of the main symptoms. The results of a
study of the effectiveness of the use of ENDOLUTEN® for the treatment of women with climacteric
syndrome are shown in Table 3.
As can be seen from the data in Table 3, in the process of using ENDOLUTEN® in patients with the
climacteric syndrome, an improvement in subjective indicators was noted, which was manifested in a
significant decrease in pain attacks in the heart, dizziness, a feeling of «fading» of the heart, and im-
proved sleep compared to those in patients before treatment. In addition, the number of complaints
of tachycardia attacks, sweating, hot flushes to the head and upper body, and fluctuations in blood
pressure decreased significantly compared with the indicators in patients before treatment and with
those in patients after treatment using conventional means (Table 3). Patients noted a significant in-
crease in performance after using ENDOLUTEN®, which they associated with the normalization of the
psychoemotional state. It is noteworthy that a stable aftereffect characterized the effect of the drug.
So, 1-2 months after the end of the course of ENDOLUTEN®, symptoms such as dizziness, tinnitus,
general weakness, increased fatigue, and sleep disturbance did not return.
Endoluten®

Dynamics of subjective indicators in patients with climacteric Table 3


syndrome.

Indicator Number of patients, (%)

Before Treatment After Treatment with After Treatment with


Conventional Means (Control Endoluten® (Primary Group)
Group)

Hot flushes in the head and upper body 78,0 59,4* 26,2*#

Increased sweating 72,6 54,1* 23,2*#

Headaches 63,4 48,3 35,2*

Changes in blood pressure 53,1 37,3 26,2*#

Pain in theheart region 59,4 38,8* 23,5*#

Tachycardia attacks 68,4 45,1* 22,4*#

Dizziness 43,8 31,2* 26,3*

Weakness 61,5 46,4 30,0*

Feeling of "sinking" heart 52,8 27,2* 24,6*

Fast fatiguability 85,2 53,9* 32,6*#

Reduced performance 86,8 56,2* 38,4*#

Irritability 93,1 62,5* 36,1*#

Tearfulness 54,2 34,8* 22,3*#

Sleep disturbance 76,8 47,6* 22,1*#

Decreased memory and attention 57,1 43,2 32,7*

* p <0.05 compared with the indicator in patients before treatment;


#p <0.05 compared with the indicator in patients after treatment with conventional means.

ENDOLUTEN® was also used in the complex therapy of men with physiogenic asthenia. The
drug had a pronounced corrective effect on the dynamics of subjective indicators. Men suffering
from physiogenic asthenia complained of general weakness, dizziness, increased fatigue, reduced
efficiency, and sleep disturbance. The additional inclusion of ENDOLUTEN® in the treatment
regimen of this category of patients led to the relief of subjective symptoms, which contributed
to a rapid and effective improvement in the general condition, while in the control group patients
who received only conventional therapy, the improvement in their condition occurred exceptionally
slowly, and after the cessation of the course of treatment subjective neurological symptoms
returned. It is important to note that when ENDOLUTEN® was used, a pronounced aftereffect was
observed: after discontinuation of the drug, the improvement in the patients’ condition continued
and persisted during the observation period - at least 1-3 months.
Thus, the use of ENDOLUTEN® is a promising direction in the treatment of pathological conditions
associated with impaired neurovegetative regulation, including climacteric syndrome, physiogenic
asthenia, vegetative-vascular dystonia, and other psychovegetative disorders.
ENDOLUTEN® was also used in cancer patients, mainly in hormone-dependent tumors (breast
cancer, cervical cancer, other localizations), after surgical treatment, and courses of radiation
Endoluten®

and chemotherapy as an adjunct to conventional complex treatment. Before treatment, all


patients showed a change in the blood count, which was expressed primarily in leukopenia and
lymphocytopenia. Patients complained of poor health, decreased muscle tone, reduced appetite,
and apathy.

Influence of Endoluten®on immunological blood parameters of cancer Table 4


patients.

Indicator Norm БPatients

Before After Treatment with After Treatment with


Treatment Conventional Means Endoluten® (Primary
(Control Group) Group)

Leukocytes, x109/l 4,0-8,8 3,14±0,11* 4,14±0,21 4,87±0,32#

Lymphocytes, x109/l 1,96±0,06 0,89±0,14* 1,42±0,18# 1,78±0,13#^

T-lymphocytes,x109/l 1,05±0,05 0,39±0,02* 0,61±0,05*# 0,79±0,04#^

"Active" T-lymphocytes (A-ROCK),x109/l 0,59±0,04 0,29±0,07* 0,35±0,06* 0,39±0,01*

RTML with KonA,% 59,1±1,7 91,5±3,8* 74,7±4,3*# 64,6±4,3#^

B-lymphocytes (EAC-ROCK), x109/l 0,53±0,04 0,30±0,06* 0,34±0,07 0,37±0,02

* p <0.05 - statistically significant compared with the normal indicator;


# p <0.05 - statistically significant compared with the indicator before treatment;
^p <0.05 - statistically significant compared with the indicator in the control group.

When ENDOLUTEN® was used in cancer patients of the primary group, a significant increase in the
total number of leukocytes, lymphocytes, and T-lymphocytes in the blood was noted, as well as an
improvement in the functional activity of T-cells (Table 4). These changes correlated with the positive
dynamics of the subjective state, expressed in improved appetite, sleep, increased muscle tone, and
decreased feelings of apathy.
As a result of the study, it was shown that ENDOLUTEN® is advisable to use in cancer patients after
courses of radiation and chemotherapy to improve the general condition, maintain hematological and
immunological parameters in the peripheral blood at the optimal level, and prevent the development
of infectious complications.
When ENDOLUTEN® was included in the complex treatment regimens for various diseases associated
with impaired neuroendocrine regulation, no side effects, complications, or drug dependence were
identified.
Thus, the results obtained indicate the therapeutic and prophylactic efficacy of ENDOLUTEN® and the
practicality of its use for prevention and in the complex treatment of various pathological conditions
and diseases associated with impaired neuroendocrine regulation of the main functions of the body.

CONCLUSION
The biologically active food supplement ENDOLUTEN® has a normalizing effect on metabolism in
the neuroendocrine system cells, particularly the pineal gland (pineal gland), and helps restore the
neuroendocrine regulation of the body’s main functions.
ENDOLUTEN® is well tolerated when taken orally, has no side effects, and can be widely used as a
therapeutic and prophylactic biologically active food supplement.
ENDOLUTEN® is recommended for use:
- To patients with dyshormonal myocardial dystrophy - orally 10-15 minutes before meals, 1-3 capsules
2-3 times a day for 15-30 days, depending on the severity of the pathological process;
Endoluten®

- To patients with mild and moderate climacteric syndrome - orally 10-15 minutes before meals, 1-2
capsules 2-3 times a day for 30-60 days, depending on the severity of the pathological process;
- To patients with physiogenic asthenia - orally 10-15 minutes before meals, 1-3 capsules 2-3 times a
day for 15-30 days, depending on the severity of the pathological process;
- To cancer patients after radiation or chemotherapy - orally 10-15 minutes before meals, 1-3 capsules
2-3 times a day for 30 days, depending on the severity of the pathological process;
- For prophylactic purposes in people whose professional activities are associated with psychoemotional,
increased physical and emotional stress - orally 10-15 minutes before meals, 1 capsule 2 times a day
for 15-30 days.
It is recommended to repeat a second course of treatment after 3-6 months.
It is advisable to recommend ENDOLUTEN®for therapeutic and prophylactic use and industrial
production.

REFERENCES
1. Karpov R.S., Slepushkin V.D., Mordovin V.F., KhavinsonV.Kh., Morozov V.G., Grishchenko V.I. - The
use of pineal gland preparations in clinical practice. - Tomsk: Publishing house of Vol. University, 1985.
-- 152 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
3. Novikov V.S., Smirnov V.S. Immune physiology of extreme conditions. – SPb.: Nauka, 1995. – 172 p.
4. Pierpaoli V., Regelson W. The Miracle of Melatonin: Per. from English - M.: Eastern Book Company,
1997. -- 256 p.
5. Slepushkin V.D., Anisimov V.N., KhavinsonV.Kh., Morozov V.G., Vasiliev N.V., Kosykh V.A. - Epiphysis,
immunity and cancer. - Tomsk: Publishing house of Vol. University, 1990. -- 148 p.
6. Tepperman J., Tepperman H. Physiology of metabolism and the endocrine system: Translation from
English - M.: Mir, 1989. -- 656 p.

RECOMMENDATIONS FOR USE


ENDOLUTEN® is a complex of peptides obtained from the pineal gland (pineal gland) tissues of young
animals. The isolated peptides have a selective effect on the neuroendocrine cells of the pineal gland,
normalize metabolism in cells, and regulate their functions.
In the clinical study, the effectiveness of ENDOLUTEN® was established for the prevention and
complex treatment of diseases and pathological conditions associated with impaired neuroendocrine
regulation (climacteric syndrome, physiogenic asthenia, desynchronosis) when the body is exposed
to extreme environmental factors, including occupational factors and psychoemotional stress, as well
as aging.
Take 1-2 capsules or tablets of ENDOLUTEN® 1-3 times a day with meals. The duration of admission
is 30 days. It is advisable to repeat the course in 4-6 months.
Do not use in case of: individual intolerance to the components, pregnancy, or breastfeeding.
There were no side effects identified when using ENDOLUTEN®.
Store in a dry, dark place at a temperature from +2 to +25 ºС.
Release form: 20 capsules or tablets containing 10 mg of ENDOLUTEN®.
Expiration date: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center of Chief Physician of the LLC «Medical Center of
the St. Petersburg Institute of Bioregulation and the St. Petersburg Institute of Bioregulation
Gerontology, SZO RAMS» for clinical work, Candidate and Gerontology, SZO RAMS», Candidate of
of Medical Sciences (PhD in Medical Science), Medical Sciences (PhD in Medical Science)
Associate Professor
6 geroprotectors
CYTOGENES
Cytogens are synthesized from natural amino acids, resulting in a copy of the
working part of the most active part of the peptide from the entire complex
contained in the extract, that is, one shortened molecule. Synthesized peptides
have a faster effect, in the beginning, starting up the function of restoring in-
ternal organs. In the future, to continue the positive dynamics in therapy, it is
recommended to take Cytomaxes.
Physiologically active short peptides should be used at any age to maintain a
normal level of metabolic processes, prevent various diseases, and slow down
the aging process in the body.
St. Petersburg Vesugen®

Report on the results of clinical studies of the


biologically active food supplement
Vesugen®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Vesugen

Biologically active food supplement VESUGEN® is a peptide complex containing amino acids: lysine,
glutamic acid, aspartic acid, which has a normalizing effect on vascular tissue.
VESUGEN® is available in tablets or capsules with an active substance content of 0.100 mg.
Experimental studies have shown that VESUGEN® has a tissue-specific effect on the cells of the tissues
of the vascular wall, improves their trophism, and provides regulating action on the metabolic process-
es in them. It contributes to the normalization of functional and morphological changes in the vascular
wall, regulates cholesterol and lipoproteins blood content, reducing the risk of various vascular defects.
Thus, it is possible to extrapolate the efficiency of the use of VESUGEN® for the restoration of vascular
function in multiple diseases, including atherosclerosis.
Atherosclerosis and its consequences are one of the leading causes of disability among the population and
death in developed countries. Age-related changes in the vascular wall and hemodynamic disturbances
lead to decreased peripheral blood circulation, vascularization of organs and tissues, the development of
various components of oxygen deficiency, and trophic disorders in various organs and tissues (2, 3, 4, 6).
Drug treatment of atherosclerosis aims to normalize lipid metabolism, blood coagulation, and metabo-
lism in the vascular wall (1, 5).
Medicines that normalize cholesterol and β-lipoprotein levels:
- Drugs, which prevent the absorption of cholesterol in the intestine (cholestyramine, β-sitosterol, dio-
sponin, polysponine);
- Drugs, which affect cholesterol synthesis in the body (clofibrate, miscleron, regardin, cetamifen, nico-
tinic acid, vitamin PP);
- Drugs, which enhance the disintegration and excretion of cholesterol from the body (linetol, arachiden).
Means that improve microcirculation, normalize vascular permeability, reduce swelling of vascular tissues
and improve metabolic processes in the vascular wall:
- prodectin, dicynon, doxium, glivenol, escuzane, etc.
Clinical trials of VESUGEN® took place at the Medical Center of the Saint Petersburg Institute of Bio-
regulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences in
patients with atherosclerosis of various arteries in the period from November 2005 to February 2006.

Distribution of patients by nosological forms, sex and age Table 1

Diagnosis Age Men Women Total


(Years)
Primary Control Primary Control Primary
group group group group group

Atherosclerosis 54-77 8 15 7 10 15 25

Total: 40

CLINICAL CHARACTERISTICS OF PATIENTS


40 patients with atherosclerosis participated in the clinical trials, 25 of whom made up the primary
group (15 men, 10 women). In addition to conventional drugs, they were prescribed VESUGEN® orally
10-15 minutes before meals, 1-2 capsules 2-3 times a day for 10-15 days, depending on the severity of
the pathological process. 15 patients (8 men, 7 women) included in the control group were prescribed
only conventional drugs. The age of patients in both groups ranged from 54 to 77 years (Table 1).
Patients in both groups had different clinical manifestations of atherosclerosis, depending on vascular
lesions of different calibers: hypertension, coronary heart disease, cerebrovascular disorders with
impaired memory, concentration, and affective lability. All patients showed progressive dynamics of
disease development.
All patients previously received symptomatic and pathogenic therapy for specific clinical signs of
vascular pathology.
Vesugen

RESEARCH METHODS
The patients’ complaints were assessed and compared, a general clinical examination of blood and urine
was carried out alongside a biochemical study of blood using the «REFLOTRON» device (Boehringer
Mannheim, Germany). A blood coagulogram and tourniquet Hesse testing were carried out to assess
homeostasis.

RESEARCH RESULTS
The use of VESUGEN® in patients with arterial atherosclerosis contributed to the improvement of
general health, normalization of sleep, especially in patients with cerebrovascular disorders. Patients
with ischemic heart disease noted a decrease in cardiac arrhythmias manifestations and angina
attacks.
Patients with essential hypertension associated the normalization of blood pressure with the use of
VESUGEN® in combination with antihypertensive drugs since it was possible to achieve long-term
remission between hypertensive crises with a lower dose of conventional antihypertensive drugs.
As we can see from table 2, the use of VESUGEN® contributed to a significant decrease in the level
of total cholesterol in the blood. There was also a tendency to decrease the content of very-low-
density lipoproteins, which are the most atherogenic.

Table 2
Influence of VESUGEN®on lipid metabolism indicators in patients with arterial
atherosclerosis
Indicator Before After treatment using After treatment using
treatment general purpose drugs Vesugen®

General cholesterol, (mmol/l) 8,2±0,3 7,0±0,2* 6,4±0,3*

Very little density lipoproteins, 1,23±0,05 1,08±0,04 0,96±0,05


(mmol/l)

Triglycerides, (mmol/l) 4,5±0,2 4,2±0,7 4,1±0,2

*P<0,05–reliable in comparison with the indicator before treatment.

Thus, the results of this study indicate the therapeutic efficacy of VESUGEN® and the advisability of
its use in the complex treatment of atherosclerosis and vascular pathology.
VESUGEN® administration has not resulted in any side effects, complications, contraindications, or
drug dependence.
VESUGEN® is convenient for administration in hospitals, outpatient, and home use.
VESUGEN® can be used for therapeutic and prophylactic purposes as a biologically active food
supplement as part of the complex therapy of vascular atherosclerosis and improve microcirculation
in various tissues in combination with any means of symptomatic and pathogenetic treatment.

CONCLUSION
The biologically active food supplement VESUGEN® has a regulatory effect on metabolism in the
vascular wall cells, contributing to the regulation of lipid metabolism and improving the state of the
vascular wall.
VESUGEN® is well tolerated at oral administration, has no side effects, has no contraindications, and
can be used as part of the complex treatment and prevention of vascular diseases of various origins.
VESUGEN® is recommended to improve the functions of the vascular wall in cases of atherosclerosis,
microcirculation disorders in organs and tissues in various diseases, and the influence of various extreme
factors on the body. It is also recommended for the elderly to maintain vascular system function.
Recommended dosages: orally 10-15 minutes before meals, 1-3 tablets or capsules 2-3 times a day
for 10-20 days. It is advisable to carry out repeated courses of treatment every 3-6 months.
Vesugen

REFERENCES
1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. - M .: the Universe, 1993 .-- 398 p.
2. Blood disorders in the elderly: Translation from English / Ed. M.J. Denham, I. Chanarin. - M.: Medicine,
1989 .-- 352 p.
3. Hormones and vascular diseases: Translation from English / Ed. R.M. Greenhalga. - M.: Medicine,
1984 .-- 344 p.
4. Korkushko O.V. Cardiovascular system and age. – M.: Medicine, 1983. – 176 p.
5. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
6. Geriatry manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.

RECOMMENDATIONS FOR USE


VESUGEN® is effective in correcting pathological changes occurring in vessels in various diseases.
VESUGEN® is well tolerated by patients, and no side effects, complications, contraindications, or drug
dependence have been identified.
Adults are recommended to take 1-2 capsules 1-2 times a day with meals. The duration of admission
is 10-30 days. It is advisable to repeat the course in 4-6 months.
Expiration Date: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Сartalaх®

Report on the results of clinical studies of the


biologically active food supplement
Сartalaх®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Сartalaх

Biologically active food supplement СARTALAХ® is a peptide complex containing amino acids: ala-
nine, glutamic acid, aspartic acid, which has a normalizing effect on the cells of the immune system.
СARTALAХ® is available in tablets or capsules with an active substance content of 0.100 mg.
Experimental studies have shown that peptides have a tissue-specific effect on the cells of those tis-
sues from which they are isolated. They improve the trophism of cartilaginous tissue cells and regulate
metabolic processes in them, reducing the risk of various joint and spine diseases. Thus, it is possible
to extrapolate the efficiency of СARTALAХ® in restoring cartilaginous tissue function in patients with
inflammatory and dystrophic-degenerative diseases of the musculoskeletal system.
Clinical trials of СARTALAХ® took place at the Medical Center of the Saint Petersburg Institute of
Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Scienc-
es in patients with osteoarthritis of joints, osteochondrosis of the spine, and osteoporosis during the
period from October 2005 to February 2006.
СARTALAХ® was administered to patients orally 10-15 minutes before meals, 1-3 tablets 2-3 times
a day for 30-45 days, depending on the severity of the pathological process.
The treatment and rehabilitation of patients with degenerative-dystrophic diseases of the joints and
spine, occurring with irreversible, progressive changes, is a complex problem that is most urgent in
geriatric practice (2, 3).
Drug therapy for degenerative-dystrophic diseases of the joints and spine includes the use of various
drugs of symptomatic and pathogenic action (1):
- Analgesics and anti-inflammatory drugs (analgin, novocaine blockade, rheopyrin, indomethacin,
brufen);
- Antihistamines (diphenhydramine, pipolfen);
- Drugs, which improve peripheral blood circulation (pachikarpin, platifillin);
- Biostimulants (rumalon, aloe, vitreous body, ATP);
- Enzyme medication (lidase, ronidase);
- Anabolic steroids (neurabol, retabolil);
- etc.

CLINICAL CHARACTERISTICS OF PATIENTS


Thirty-three patients diagnosed with osteoarthritis, osteochondrosis, or osteoporosis participated in
the clinical trials of СARTALAХ®. Ten patients with osteoarthritis of the knee joints (7 men, 3 women),
15 patients with osteochondrosis of the spine (6 men, 9 women), and 8 patients with osteoporosis (8
women). The patients’ age ranged from 45 to 78 years.
The control group included 31 patients with similar diagnoses, gender, and age. You can see the dis-
tribution of patients by diagnosis, sex, and age in Table 1.
Patients with osteoarthritis of the knee joints complained of pain and limitation of flexion and exten-
sion in the joints when walking. Representatives of the senior age group suffered from deformity of
the joints, atrophy of the femoral muscles, and weakening of the ligamentous apparatus of the joints.
Patients in the second group often noted the pain in the lower back with irradiation along the sciatic
nerve, significantly increasing with a change in body position, walking, and physical activity.
Osteoporotic patients complained of frequent bone fractures arising from minor trauma or even for
no apparent reason.
In patients of the primary and control groups, the duration of the disease ranged from 5 to 20 years.
A progressive dynamic of the development of the pathological process was noted.
All patients previously received analgesics and anti-inflammatory drugs for a long time, the use of
which resulted in a short-term therapeutic effect, requiring an increase in the dose of drugs for the
course of treatment and their prolonged use.
Patients in the control group received treatment using conventional drugs. In addition to traditional
medicines, patients of the primary group have been taking СARTALAХ® 2-3 capsules 2-3 times a day
before meals for 30-45 days.
Сartalaх

Distribution of patients by diagnosis, sex and age Table 1

Diagnosis Age Men Women Total


(years)
Control group Primary Control Primary Control group Primary
group group group group

Osteoarthritis of the 59-78 6 7 3 3 9 10


knee joints

Osteochondrosis of 45-69 7 6 8 9 15 15
the spine

Osteoporosis 45-65 - - 7 8 7 8

Total: 13 13 11 12 31 33

RESEARCH METHODS
СARTALAХ® efficiency assessment was carried out by analyzing the patient complaints progression and
the objective parameters: general clinical analysis of blood and urine, biochemical blood analysis, X-ray
examination.

RESEARCH RESULTS
It is important to note that radiology symptoms of degenerate and dystrophic diseases of joints and spine
are objective diagnostic criteria of pathological process development stage and are of high prognostic
importance for the drug therapy carried out.
The use of СARTALAХ® in patients with knee joint osteoarthritis contributed to decreased pain
syndrome and increased joint mobility in 68.5% of cases. At the same time, pain symptoms stopped
mostly in radiologically identifiable initial stages of the disease: joint space narrowing between patella
and femur, lateral osteophytes of the patella and femoral condyle. There were no considerable dynamics
of roentgenological symptoms during this period.
In patients in the advanced stage of arthrosis, a similar but less pronounced dynamic of subjective
indicators was observed. Such subjective sensations were very favorable since this stage of the disease
was diagnosed in patients of the senior age group.
In patients with osteochondrosis of the lumbar spine, using СARTALAХ® against the background of
complex therapy helped reduce pain in 53.7% of cases. In these cases, long-term (at least 45-60 days) use
of СARTALAХ® smoothed the pain symptoms arising from pressure on the spine and lower extremities
and increased the spine’s mobility. Such changes were most typical for middle-aged people. Age-related
disease progression, accompanied by typical radiological symptoms (narrowing of the space between
adjacent vertebral bodies due to flattening degenerate intervertebral disks; anterior and posterior
osteophytes of the vertebral bodies, arthritic changes of posterior and lateral intervertebral joints in the
form of narrowing of the spaces, irregularity of the contours, osteophytes at the margins of the joint ends,
and changes of the configuration of intervertebral foramens), resulted in the development of spondylosis
and spondyloarthrosis, and the formation of neurodystrophic and neurovascular syndromes.
After long-term administration of the drug, the patients with osteoporosis have shown stabilization
of metabolic processes in the bone tissue: reduction in the number of typical fractures, considerable
acceleration of restoration of the function of the musculoskeletal system, and decrease in the time of
stay in the hospital.
All patients showed a significant improvement in the main symptoms of their diseases.
СARTALAХ® does not cause side effects, complications, or drug dependence.
Thus the results of the study carried out prove the efficiency of СARTALAХ® and practicality of its use
for complex treatment and prevention of degenerate and dystrophic diseases of the joints and vertebral
Сartalaх

column combined with any means of symptomatic and pathogenic therapy used for the treatment of this
group of diseases (analgesics, anti-inflammatory, antihistamine and vascular preparations, bio-stimulators,
enzyme preparations, anabolic steroids, vitamins, etc.).

CONCLUSION
Biologically active food supplement СARTALAХ® promotes the normalization of metabolic processes
in cartilaginous tissue and slows down its involutive changes.
СARTALAХ® can be used for therapeutic and preventative purposes in the form of a biologically
active food supplement combined with any means of symptomatic and pathogenetic therapy used
to treat degenerative-dystrophic diseases of the joints and spine (osteoarthritis, osteochondrosis,
osteoporosis, etc.)
СARTALAХ® is well tolerated by patients when taken orally, has no side effects, and can be widely
used as a therapeutic and prophylactic biologically active food supplement.
СARTALAХ® is recommended for:
- People with osteoarthritis of the joints - orally 10-15 minutes before meals, 2 tablets or capsules 3
times a day for 45 days;
- People with osteochondrosis of the spine - orally 10-15 minutes before meals, 2 tablets or capsules
3 times a day for 45 days;
- Peoplewith osteoporosis - orally 2 tablets or capsules 2 times a day 10-15 minutes before meals for
30 days.
It is recommended to repeat the course of treatment in 3-6 months.
It is advisable to recommend СARTALAХ® for therapeutic and prophylactic use and industrial
production.

REFERENCES
1. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO
“Gamta”, 1993.
2. V.A. Nasonova, M.G. Astapenko Clinical Rheumatology: A Guide for Physicians. - M .: Medicine,
1989 .-- 592 p.
3. Geriatric manual / Ed. D.F. Chebotarev, N.B. Mankovsky. – M.: Medicine, 1982. – 544 p.

RECOMMENDATIONS FOR USE


Cartalax® was developed to correct and prevent connective tissue disorders that occur in various
diseases. It is effective after extreme physical activity and to prevent degenerative processes in the
spine and joints in elderly and senile people.
Cartalax® is well tolerated by patients, and there were no side effects, complications, contraindica-
tions, or drug dependence observed.
Adults are advised to take 1-2 capsules 1-2 times daily with meals. The duration of admission is 10-
30 days. It is advisable to repeat the course in 4-6 months.
Expiration date: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center Chief Physician of the LLC «Medical Center of
of the St. Petersburg Institute of Bioregulation the St. Petersburg Institute of Bioregulation
and Gerontology, SZO RAMS» for clinical work, and Gerontology, SZO RAMS», Candidate of
Candidate of Medical Sciences (PhD in Medical Medical Sciences (PhD in Medical Science)
Science), Associate Professor
St. Petersburg Сrystagen®

Report on the results of clinical studies of the


biologically active food supplement
Сrystagen®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Сrystagen

Biologically active food supplement CRYSTAGEN® is a peptide complex containing amino acids: glu-
tamic acid, aspartic acid, and proline, which has a normalizing effect on the cells of the immune system.
CRYSTAGEN® is available in tablets or capsules with an active substance content of 0.100 mg.
CRYSTAGEN® regulates metabolic processes in the cells of the immune system, restores impaired
immunological reactivity, and stimulates regeneration processes in case of their suppression. Experi-
mental studies have shown that peptides have a tissue-specific effect on the cells of those tissues from
which they are isolated. Thus, it is possible to extrapolate the efficiency of KRYSTAGEN® to restore
the function of the immune system in various pyoinflammatory and other diseases characterized by
the suppression of the immune status of patients.
It is known that various factors of physical, chemical, and biological nature, depending on the duration
and intensity of their impact on the human body, can lead to depletion of adaptive and compensatory
mechanisms and cause profound disorders of various segments of the immune defense system (2, 3).
Pathological disorders in the immune system usually result in a long-term course of the basic disease
with a tendency to relapse, a decrease in the body’s resistance to infection, and the development of
severe complications.
Among the drugs that contribute to the restoration of immunological reactivity are immunomodulators
of various origins: enzyme medication (trypsin, lysozyme), bacterial polysaccharides (pyrogenal, pro-
digiosan), yeast polysaccharides (zymosan, glucans, propermil, dextrans), vaccines (BCG), nucleic acid
medication ( sodium nucleinate), purine and pyrimidine derivatives, levamisole, diucifon, traditional
medicine, and many others (1, 2).
Clinical trials of СRYSTAGEN® were carried out in the period from November 2005 to February 2006
at the Medical Center of the Saint Petersburg Institute of Bioregulation and Gerontology of the North-
west Branch of the Russian Academy of Medical Sciences, in patients after long-term exposure to low
doses of ionizing radiation, including cancer patients after radiation and chemotherapy.
The primary group consisted of 40 patients (23 men, 17 women), who, in addition to conventional
treatments, were prescribed CRYSTAGEN® 1-3 capsules 2-3 times a day before meals for 15-20 days,
depending on the severity of immune status disorders. Patients in the control group received only
general-purpose medication.
The age of patients in both groups ranged from 38 to 69 years. The distribution of patients by noso-
logical forms, sex, and age is presented in Table 1.

Distribution of patients by nosological forms, sex and age. Table 1

Diagnosis Age (years) Men Women Total

Control group Primary Control group Primary Control group Primary


group group group

State after low-dose 38-56 10 14 5 6 15 20


ionizing radiation
influence

State after radiation 43-69 8 9 7 11 15 20


and chemotherapy in
oncological patients

Total 18 23 12 17 30 40

RESEARCH RESULTS
СRYSTAGEN® efficiency was assessed by changes of the patients’ complaints and by the number
of objective parameters: General clinical analysis of blood and urine, the immunological study of
peripheral blood (the number of T- and B-lymphocytes was determined by the immunofluorescence
method with monoclonal antibodies to differentiation lymphocyte antigens CD3, CD4, CD8, CD20;
the content of immunoglobulins of various classes - by the method of radial immunodiffusion in gel
according to Mancini; functional activity of T-lymphocytes - using leukocyte migration inhibition test
Сrystagen

(LMIT) with ConA).


Studies have shown that 90% of people living in an ecologically unfavorable area have immune status
disorders in the form of a decrease in the number of CD3+, CD4+ cells, with a slight increase in
lymphocytes with the CD8+ phenotype, which indicates a decrease in the level of immunoreactivity
(CD4+/CD8+). The results of LMIT with ConA characterize a decrease in the functional activity of
T-lymphocytes (mainly CD8+, i.e., T-suppressors/killers). The number of CD20+ -cells, representing a
subpopulation of B-lymphocytes, was not significantly different from normal values, but, at the same
time, there was an increase in the number of M and G immunoglobulins in blood serum (Table 2).
It should be noted that the quantitative indicators of the content of CD3+ and CD4+ cells are typical
for lower limits of physiological fluctuations in their number in patients of such age, which may indicate
premature aging of the immune system. As a rule, people with a secondary immune-deficiency condition
have a pronounced asthenic syndrome and significant changes in the cardiovascular system.

CRYSTAGEN® influence of the cellular and humoral immunity parameters in Table 2


patients, who have been exposed to low doses of ionizing radiation
Parameter Before treatment After treatment with general After treatment using Crystagen®
purpose medication

Leucocytes, ×109/l 5,1± 5,2±0,5 5,4±0,3

Lymphocytes, % 28,1±2,2 29,7±2,1 32,1±1,8


×109/l 1,62±0,03 1,56±0,06 1,67±0,04

CD3+, % 45,1±2,1 49,3±2,3 53,3±2,2*


×10 /l
9 1,50±0,03 1,61±0,02 1,77±0,03*

CD4 , %
+
26,3±2,4 29,7±2,4 32,1±1,8*
×109/l 0,44±0,02 0,47±0,04 0,56±0,05*

CD8+, % 26,4±1,5 25,7±1,6 24,9±1,8


×109/l 0,43±0,05 0,42±0,03 0,46±0,07

CD4+/CD8+
1,0 1,1 1,2

CD20+, % 12,2±0,5 12,1±0,2 12,2±0,6


×10 /l
9 0,20±0,02 0,22±0,01 0,21±0,01

Leukocytemigrationinhibitiontest, % 86,3±4,7 74,7±4,2* 71,9±4,4*

IgM, (g/l) 1,76±0,03 1,69±0,06 1,74±0,02

IgG, (g/l) 15,1±1,2 15,4±1,4 15,2±1,5

IgА, (g/l) 2,0±0,2 2,1±0,1 2,1±0,2

* Р<0,05 – significantly compared to the indicator before treatment.

The results of the studies conducted convincingly indicate that CRYSTAGEN® is an effective remedy
for correcting secondary immune deficiency that develops in response to the influence of extreme
factors. The use of KRYSTAGEN® in combination with symptomatic agents made it possible to nor-
malize the impaired parameters of the immune system in 78% of cases.
According to the data provided, the greatest effect from the use of CRYSTAGEN® was identified in
subpopulations of T-lymphocytes and their functional activity (a significant increase in the number of
CD3+ and CD4+ lymphocytes, normalization of the CD4 /CD8+ ratio). A less distinct reaction was
noticed in the B-system, probably, due to its higher conservativity.
After the course of treatment using CRYSTAGEN®, patients who received small doses of ionizing
radiation noted a significant improvement in their general condition and a decrease in the severity of
the asthenic syndrome, which always accompanies secondary immunodeficiencies.
Сrystagen

Oncological patients after radiation and chemotherapy had increased normalization of immunological
indices compared to the control group, which resulted in improvement of their general condition and
a decrease in the rate of complications. It is noteworthy that the primary group patients tolerated
radiation and chemotherapy better and were able to complete the entire course of treatment (in the
control group - 79%).

CONCLUSION
Clinical trials have shown that СRYSTAGEN® promotes normalization of cellular immunity parameters,
stimulates tissue regeneration processes in case of inhibition, and does not result in any side effects,
complications, or drug dependence. It can be used for treatment and prophylactic purposes combined
with any means of symptomatic and pathogenetic therapy used to correct secondary immunodeficiency
conditions (immune modulators, adaptogens, vitamins, etc.).
CRYSTAGEN® is recommended for accelerating the restoration of the immune system functions after
infectious diseases, radiation, and chemotherapy, influence on the body of various extreme factors
(including ionizing and UHF-radiation). It is also recommended for elderly people to maintain immune
system function.
It is recommended to take CRYSTAGEN® 10-15 minutes before meals, 1-3 tablets or capsules 2-3
times a day for 20-30 days.
A second course is recommended in 3-6 months.
The clinical study showed no side effects, complications, contraindications, or drug dependence when
using СRYSTAGEN®.

REFERENCES
1. Drannik G.N., Grinevich Y.A., Disik G.M. Immunotropicmedication. – Kiev Zdorov’ya, 1994. – 288 p.
2. Mashkovsky M.D. Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
3. Novikov V.S., Smirnov V.S. Immune physiology of extreme conditions. – SPb.: Nauka, 1995. – 172 p.
4. Schek M.G., Kosinets A.N., Adamenko G.P. Immunological aspects of surgical infection. – Vitebsk:
B. i., 1994. – 140 p.

RECOMMENDATIONS FOR USE


CRYSTAGEN® was developed to correct the immune system and prevent hormonogenesis disorders
that occur in various diseases. It is effective for maintaining the function of the immune system in el-
derly and senile people, in case of chronic intoxication, as well as for rejuvenating the body as part of
complex programs. CRYSTAGEN® is well tolerated by patients, and there were no side effects, com-
plications, contraindications, or drug dependence observed.
Adults are advised to take 1-2 capsules 1-2 times daily with meals. The duration of admission is 10-
30 days. It is advisable to repeat the course in 4-6 months.
Expiration date: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko Executor: O.U. Raigorodsky

Deputy Director of the LLC «Medical Center Chief Physician of the LLC «Medical
of the St. Petersburg Institute of Bioregulation Center of the St. Petersburg Institute of
and Gerontology, SZO RAMS» for clinical work, Bioregulation and Gerontology, SZO RAMS»,
Candidate of Medical Sciences (PhD in Medical Candidate of Medical Sciences (PhD in
Science), Associate Professor Medical Science)
St. Petersburg Ovagen®

Report on the results of clinical studies of the


biologically active food supplement
Ovagen®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Ovagen

Biologically active food supplement OVAGEN® is a peptide complex containing amino acids: glutamic
acid, aspartic acid, and leucine, which has a normalizing effect on liver cells.
OVAGEN® is available in tablets or capsules with an active substance content of 0.100 mg.
Clinical trials of OVAGEN® were carried out at the Medical Center of the Saint Petersburg Institute of
Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences
in patients with chronic hepatitis and oncological patients after a course of radiation or chemotherapy
in the period from October 2005 to February 2006.
OVAGEN® was administered to patients orally 10-15 minutes before meals, 1-2 tablets 2 times a day
for 10-20 days, depending on the severity of the pathological process.
Currently, there is an increase in the number of patients with chronic liver diseases, which are prevalent
mainly in people of working age. Unfavorable social and environmental factors mainly cause them.
Chronic hepatitis is not considered an outcome of an acute infectious process but as a form of the
course of the infectious process (2, 3).
In the treatment of patients with chronic hepatitis, taking into account the pathogenetic mechanisms,
the following conventional therapeutic agents are used (1):
- Drugs that improve the metabolism of liver cells (hepatoprotectors) – (Essentiale, Legalon, Sirepar);
- Stimulants of bile secretion – (Liv-52);
- B group vitamins (B1, B6, B12, ascorbic acid);
- etc.

CLINICAL CHARACTERISTICS OF PATIENTS


Clinical trials were carried out in 40 patients with chronic hepatitis and oncological patients after a
course of chemotherapy, including 25 men and 15 women from 38 to 67 years old (Table 1). In addition
to conventional treatment, patients of the primary group received OVAGEN® - 2 capsules 2 times a
day before meals for 15-20 days. The duration of their disease ranged from 3 to 10 years.
The control group consisted of 34 similar patients who were prescribed only conventional medication.

Distribution of patients by nosological forms, sex and age. Table 1

Diagnosis Age (years) Men Women Total

Chronic persisting hepatitis 38-67 14 6 20

State after chemotherapy course in oncological 50-65 11 9 20


patients

Total: 25 15 40

Most patients complained about pain in the right hypochondrium, general weakness, and rapid
fatigability. 78% of patients had dyspeptic disorders. 55% of patients had hyperbilirubinemia, an
increase in the alanine aminotransferase level, and an increase in the globulin fraction of blood
proteins, mainly due to the M immunoglobulin fraction, which indicates a specific activity of the
chronic inflammatory process.

RESEARCH METHODS
The complaints were assessed subjectively at different times. The following tests were carried
out: general clinical examination of blood and urine, biochemical and immunological blood tests
(determination of immunoglobulins using the Mancini method), and liver ultrasound examination.

RESEARCH RESULTS
After treatment with OVAGEN®, most patients noted a significant increase in energy, appetite, and
Ovagen

performance. 48% of patients noticed a considerable decrease in the intensity of the pain syndrome.
Cancer patients noted an improvement in their well-being, a decrease in weakness, and the intensity
of dyspeptic disorders.

Influence of OVAGEN® on Biochemical indicators of peripheral blood in Table 2


patients with chronic hepatitis.

Indicator Before After Treatment with After Treatment with Ovagen®


treatment Conventional Means

Cholesterol, (mmol/l) 4,8±0,3 4,9±0,1 4,7±0,6

Bilirubin, (mcmol/l) 28,4±0,5 26,4±1,1 21,5±0,7*

AST, (mmol/hxl) 38,6±2,1 40,2±2,2 36,1±2,5

ALT, (mmol/hxl) 50,2±3,2 44,3±3,1* 41,4±2,8*

g-GT, (mmol/hxl) 44,7±4,3 42,6±4,0 41,4±4,1

Triglycerides, (mmol/l) 2,2±0,2 2,1±0,7 1,8±0,4

* P <0.05 - reliablein comparison with the parameter before treatment.

When analyzing the effectiveness of OVAGEN®, particular attention was paid to assessing the results
of biochemical studies characterizing the liver’s aminotransferase activity, pigment, and protein-form-
ing functions. Objectively, after using OVAGEN®, biochemical parameters were stabilizing in most
patients: bilirubin level, alanine aminotransferase level (Table 2). The study of peripheral blood immu-
noglobulins, which are an essential criterion for the inflammatory process activity, after a course of
treatment using OVAGEN® showed a decrease in IgM level (Table 3).
Thus, the results of clinical trials indicate the hepatoprotective properties of OVAGEN® and the
advisability of its use in the complex treatment of acute and chronic forms of liver damage in cancer
patients after radiation and chemotherapy as for the prevention of various liver diseases and their
complications.
During clinical trials of OVAGEN®, there were no side effects, contraindications, complications, or
drug dependence.

Influence of OVAGEN® on immunological parameters of patients with Table 3


chronic hepatitis

Parameters Before treatment After treatment with general After treatment using Ovagen®
purpose drugs

IgA, (g/l) 2,2±0,08 2,2±0,02 2,3±0,08

IgM, (g/l) 3,6±0,03 2,5±0,08* 2,1±0,03*

IgG, (g/l) 14,0±1,2 14,2±1,0 14,1±1,1

* P <0.05 - reliable in comparison with the parameter before treatment.


Ovagen

REFERENCES
1. Mashkovsky M.D. Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
2. Podymova S.D. Liver diseases. – M.: Medicine, 1984. – 480 p.
3. Rakhmanova A.G., Prigozhina V.K., Neverov V.A. Infectious diseases: Manual for general practitioners.
– M.-SPb.: Pub. “SSZ”, 1995. – 304 p.

RECOMMENDATIONS FOR USE


OVAGEN® is recommended for the acceleration of the recovery of liver function in acute or chronic
liver damage, in treatment using antibiotics and other drugs that adversely affect the liver, malnutrition,
for cancer patients after radiation or chemotherapy and when the body is exposed to various extreme
factors. In addition, the drug is recommended for the elderly to maintain liver function.
OVAGEN® is recommended to be taken 10-15 minutes before meals, 1-2 tablets or capsules 2-3
times a day for 15-20 days.
A second course could be repeated in 3 - 6 months.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Pinealon®

Report on the results of clinical studies of the


biologically active food supplement
Pinealon®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Pinealon

Biologically active food supplement PINEALON® is a peptide complex containing amino acids: glutamic
acid, aspartic acid, and arginine, which has a normalizing effect on brain tissue.
PINEALON® is available in tablets or capsules with an active substance content of 0.100 mg.
Experimental studies have shown that PINEALON® has a tissue-specific effect on brain cells: it regu-
lates metabolic processes in brain cells, increases the reserve capacity of the brain, exerts a beneficial
impact on the body’s adaptation processes in extreme conditions, has antioxidant properties, and
regulates the processes of peroxidation in the cerebral cortex of the brain. This allows us to assume
the effectiveness of using PINEALON® to restore the functions of the central nervous system in the
case of disorders of various origins.
Treatment of central nervous system diseases is of particular relevance because they lead to social
adaptation disorder and disability of patients (2).
Currently, the treatment of patients with diseases of the central nervous system, given the pathoge-
netic mechanisms, is carried out using the following traditional therapeutic agents of various action
types (1, 3):
- Influence on metabolism and integrative functions of the brain – (cerebrolysin, piracetam, enceph-
alolysate);
- Normalization of cerebral and systemic circulation – (stugeron, cavinton);
- Relief of psychopathological symptoms – (meridin, amitriptyline);
- Correction of changes in the bioelectric activity of the brain – (phenobarbital, Convulex);
- Impact on liquorodynamic disturbances – (verospiron, furosemide);
- Prevention and inhibition of the development of adhesions – (aloe, lidase);
- Correction of immunopathological reactions – (levamisole, tavegil).

Clinical trials of PINEALON® took place from November 2005 to February 2006 at the Medical Center
of the Saint Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of the
Russian Academy of Medical Sciences.
In total, 42 patients with various diseases of the central nervous system participated: long-term con-
sequences of craniocerebral injury (the duration of the injuries varied between 1 to 10 years), post-
stroke conditions, vascular encephalopathies, decreased mental performance, memory, attention. You
can see the distribution of patients by nosological forms, sex, and age in Table 1.
In addition to conventional treatment, patients in the primary group received PINEALON® 1-2 capsules
2-3 times a day before meals for 10-20 days, depending on the severity of the pathological process.
The control group consisted of 32 similar patients who received only conventional treatment.
All patients have been taking symptomatic and pathogenetic drugs. Taking these drugs has resulted
in a short-term therapeutic effect, which required an increase in the dose per treatment course and
their prolonged use.
Pinealon

Distribution of the patients by nosological groups, sex and age. Table 1

Diagnosis Age Men Women Total


(years)
Control group Main Control group Main Control group Main
group group group

Long-term effects of 35-65 5 7 1 1 6 8


craniocerebral injury

State after stroke 56-75 5 6 1 3 6 9

Vascular 55-78 5 7 5 8 10 15
encephalopathies

Signs of decreased 51-68 6 5 4 5 10 10


mental capacity,
memory, attention.

Total: 21 25 11 17 32 42

RESEARCH METHODS
The effectiveness of PINEALON® was assessed by the dynamics of subjective indicators and objec-
tively using the methods of proofreading and electroencephalography (EEG).

RESEARCH RESULTS
After administrating PINEALON® to patients of the primary group, a good clinical result was observed
in 66.7% of cases, satisfactory - in 23.8%, no positive effect - in 9.5% of cases (in the control group -
Table 2). There was no negative effect of PINEALON® on the condition of the patients.

PINEALON® efficiency in patients with diseases of the central


nervous system Table 2

Treatment results Group of patients

Treatment using general purpose medication Treatment using “Pinealon”

Abs. % Abs. %

Good 9 28,1 28 66,7*

Satisfactory 13 40,6 10 23,8

Not satisfactory 10 31,2 4 9,5*

Total: 32 100 42 100

* Р<0,05 in comparison with the parameters after treatment using general purpose drugs.

When comparing the subjective indicators of the state of patients before and after the use of PINE-
ALON®, it was found that the number of health complaints decreased by 2-3 times. Patients noted
an improvement in memory, intelligence, a decrease in the intensity and duration of headaches, the
appearance of emotional balance, volitional qualities, and a sense of rest after a night’s sleep (Table 3).
Patients with the consequences of craniocerebral injury and stroke noticed a moderate regression
of focal symptoms, improved speech function with motor and sensory aphasia, and decreased mus-
cle spasticity.
Pinealon

Comparative assessment of the effect of PINEALON® and other treatment methods on the integral
function of the brain - attention and bioelectrical activity of the brain were studied using a correc-
tive test and electroencephalography, respectively.
Table 3
Influence of PINEALON® on subjective indicators of the state of
health of the patients.
Indicator Before After treatment using general After treatment using PINEALON®, %
treatment, % purpose drugs, %

Headaches 81,2 51,3# 36,4#

Sleep disturbances 52,6 39,2# 26,1#

Emotional instability 73,9 48,4# 27,2*#

Memory disturbance 57,2 48,1 34,2*#

Absent-mindedness 44,8 41,1 27,5*#

Rapid fatigability 78,3 50,7# 39,3*#

# P <0.05 compared with the indicator in patients before treatment;


* P <0.05 compared with the indicator in patients after treatment with general purpose drugs.

Influence of PINEALON® on the dynamics of indicators of performing a Table 4


correction test by patients with diseases of the central nervous system

Group of examined patients Number of symbols viewed Number of errors

Healthy 1760,8±75,1 8,26±1,9

Patients before treatment 1257,6±68,2 16,3±1,2

Patients after treatment with general purpose drugs 1611,3±61,2* 12,5±1,1*

Patients after treatment using Pinealon® 1669,1±56,3*# 9,1±0,8*#

* P <0.05 compared with the indicator in patients before treatment;


# P <0.05 compared with the indicator in patients after treatment with general purpose drugs.
You can observe the results of completing the correction task by the patients after treatment using
various methods in table 4. According to the table, the patients after treatment using PINEALON®
have a higher number of symbols viewed and fewer errors. The best results were obtained in the pri-
mary group patients when analyzing the dynamics of performing the correction test before and after
treatment compared to patients in the control group. This was expressed in the absence of sharp fluc-
tuations in the number of viewed symbols for equal periods, the presence of a period of «workability»
by the middle of the task, and a gradual decrease in the curve by the end of the task, which indicates
greater stability of attention after treatment.
To assess the effect of PINEALON® on the bioelectrical activity of the brain, a visual analysis of the
EEG was performed by distributing them by type and the calculation of the alpha index before and
after treatment. EEG was performed selectively on patients with the most pronounced manifestations
Pinealon

of pathological processes. The research results are presented in Table 5.

The influence of PINEALON® on the characteristics of the types of Table 5


electroencephalograms in patients with diseases of the central nervous system.

Group of patients examined EEG Type

III IV V

Before After Before After Before After


treatment treatment treatment treatment treatment treatment

After treatment with general purpose 6 (19%) 5 (16%) 11 (34%) 10 (31%) 10 (31%) 9 (28%)
drugs

After treatment using PINEALON® 9 (21%) 7 (17%) 14 (33%) 9 (21%) 13 (31%) 7 (17%)

Before treatment, pathological (III, IV, V) types of EEG prevailed in the examined patients in different
groups. Type III EEG was characterized by the presence of a so-called non-dominant curve at a low
amplitude level (no higher than 30-35 μV), the presence of irregular alpha activity, or even its absence.
The IV type of EEG was characterized by a highly emphasized regularity of rhythms, blurring of zonal
differences. The V type of EEG was characterized by irregular slow activity with an amplitude above
35 μV, sharp waves, and paroxysmal discharges.
The most pronounced changes in the brain’s bioelectric activity were observed in patients after treat-
ment with PINEALON®. First of all, this was confirmed on the EEG in a clearer modulation and res-
toration of zonal differences in the alpha rhythm, a weakening of the severity of irritative processes,
in some cases - the disappearance of paroxysmal discharges.

Effect of PINEALON® on the dynamics of changes in the alpha index in patients Table 6
with diseases of the central nervous system

Group of patients examined Alpha index

Before treatment After treatment

Healthy 51,7±3,2 -

Patients using general purpose drugs 36,2±3,4 43,2±4,5

Patients using Pinealon® 1669,1±56,3*# 46,1±4,5*#

* P <0.05 compared with the indicator in patients before treatment;


# P <0.05 compared with the indicator in patients after treatment with general purpose drugs.

In addition to visual EEG assessment, the alpha index was calculated in patients before and after treat-
ment (Table 6). It was found that there was a significant increase in the alpha index in patients of the
study groups under the influence of therapy. The value of the alpha index was significantly higher in
the group of patients after treatment with PINEALON® compared with the indicators in other groups.
However, the degree of change in the alpha index in patients receiving different treatments was not
the same.
Pinealon

CONCLUSION
Based on the data obtained, it is possible to conclude that the activation of reserve capacities of the
cerebral cortex with the help of PINEALON® improves the integral functions of the brain.
Thus, the clinical study results indicate the effectiveness and practicality of using PINEALON® in the
complex treatment and prevention of diseases of the central nervous system of various origins.
PINEALON® does not cause side effects, complications, or drug dependence; no contraindications
have been identified during clinical trials.
PINEALON® can be used for therapeutic and prophylactic purposes, including in combination with
any means of symptomatic therapy used in neurological practice (vascular, nootropic, absorbable,
anticonvulsant, vitamins, etc.).

REFERENCES
1. Kovalev G.V. Nootropic medicines. – Volgograd: Nizh.-Volzh. publishing house, 1990. – 368 p.
2. Treatment of nervous diseases: Translated from English/ Edited by V.K.Viderholt. – M.: Medicine,
1984. – 560 p.
3. Mashkovsky M.D. Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO
“Gamta”, 1993.

RECOMMENDATIONS FOR USE


PINEALON®is recommended to be used to accelerate the recovery of craniocerebral injuries, stroke,
intellectual disorders, and exposure to various extreme factors. In addition,the medication is recom-
mended for the elderly to maintain mental performance.
PINEALON®is recommended to be taken 10-15 minutes before meals, 1-3 tablets or capsules 2-3
times a day for 10-20 days.
It is desirable to repeat the course in 3 - 6 months.
There are no contraindications and side effects when using PINEALON®.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)
St. Petersburg Сhonluten®

Report on the results of clinical studies of the


biologically active food supplement
Сhonluten®

«APPROVED» V.K. KHAVINSON


Director of the Medical Center St. Petersburg Institute of Bioregulation
and Gerontology SZO RAMS, Corresponding Member of the Russian Acad-
emy of Medical Sciences, Professor, Doctor of Medical Sciences

2011
Сhonluten

Biologically active food supplement СHONLUTEN® is a peptide complex containing amino acids: glu-
tamic acid, aspartic acid, glycine, which has a normalizing effect on the cells of the bronchial mucosa.
СHONLUTEN® is available in tablets or capsules with an active substance content of 0.100 mg.
The results of experimental studies have shown that СHONLUTEN® has a tissue-specific effect on
the cells of the bronchial mucosa, improves their trophism and has a regulatory effect on metabolic
processes in them, contributes to the normalization of functional and morphological changes in the
bronchial mucosa, reducing the risk of various inflammatory diseases of the bronchi and lungs. This
suggests the effectiveness of СHONLUTEN®’s use to restore the function of the respiratory system
in various inflammatory diseases.
Chronic bronchitis is a severe medical and social problem due to its high prevalence, growing sickness
rate, mortality, and enormous economic damage to society. Chronic bronchitis is the main form in the
structure of chronic nonspecific lung diseases (3, 4).
Medical treatment of chronic bronchitis includes the use of the following drugs (1, 2):
- Antibiotics (penicillin, kanamycin, oleandomycin);
- Sulfonomides (biseptol, madribone);
- Bronchodilators (aminophylline, ephedrine, salbutamol, phentolamine);
- Expectorants (bromhexine, thermopsis);
- Immunomodulators (thymalin, taktivin);
- Glucocorticoids (hydrocortisone, prednisolone, dexamethasone), etc.
Clinical trials of СHONLUTEN®were carried out at the Medical Center of the St. Petersburg Institute
of Bioregulation and Gerontology, SZO RAMS in patients with chronic bronchitis with an asthmatic
component in the period from November 2005 to February 2006.

CLINICAL CHARACTERISTICS OF PATIENTS


Treatment with СHONLUTEN® was carried out in 23 patients (15 men, 8 women) with a diagnosis
of chronic bronchitis with an asthmatic component, remission phase. The patients’ age ranged from
38 to 65 years.
Patients complained of coughing up phlegm, mainly in the morning, general weakness, sweating,
shortness of breath during physical activity, recurrent attacks of suffocation, sleep disturbances, and
headaches.
The duration of the course of the disease in patients was 3-10 years, and there were progressive dy-
namics of the development of the pathological process.
All patients previously received symptomatic and pathogenetic therapy for this disease.
The control group consisted of 19 patients with a similar disease who were prescribed traditional
treatment.

RESEARCH METHODS
СHONLUTEN®’s efficiency assessment was carried out by analyzing the patients’ complaints pro-
gression, general clinical examinations of blood and urine, and biochemical blood study using the
REFLOTRON apparatus (Boehringer Mannheim, Germany). Additionally, radiography of the lungs, mi-
croscopic examination of sputum, and analysis of the function of external respiration were performed.

RESEARCH RESULTS
It was found that the use of CHONLUTEN® against the background of conventional therapy in patients
with chronic bronchitis in 73% of cases contributed to an improvement in well-being, a decrease in
the frequency of coughing attacks, asthma attacks, and a decrease in the amount of sputum secreted.
The auscultation of the lungs in dynamics testified to the disappearance of dry, whistling, and buzzing
wheezing in some cases.
In the process of using CHONLUTEN®, a decrease in the microscopic structures of sputum was ob-
served: leukocytes, epithelial cells, Kurshman coils, which indicates a decrease in the inflammatory
and bronchospastic manifestations of the disease.
Сhonluten

The study of the function of external respiration showed that against the background of treatment
with the use of CHONLUTEN®, the indices of bronchial patency improved (Table 1).

The effect of СHONLUTEN®on the indicators of external respiration in patients with Table 1
chronic bronchitis with an asthmatic component

Indicators Before treatment After treatment using After treatment using


conventional drugs Сhonluten®

Lung vital capacity (VC), ml 3830,8 ±312,7 3950,3±298,12 4150,4 ±265,6

Total lung capacity (OEL), ml 4800,6±334,7 5050,3±236,9 5200,7±247,4

Expiratory forced vital capacity of the lungs 2850,6±158,4 3200,7±187,5 3800,8±136,9*


(EFVL), ml

* - P <0.05 compared to the values before treatment.

The results of the study of the function of external respiration indicate a sufficiently compensated
pathological process in the lungs, but, at the same time, there are phenomena of impaired bronchial
patency, mainly due to spasms of small bronchioles. The use of СHONLUTEN®’s positively impacted
the dynamics of the development of this process.
Thus, the results of this study indicate the therapeutic efficacy of СHONLUTEN® and the advisability
of its use in the complex treatment of chronic bronchitis with an asthmatic component.
In the process of using СHONLUTEN®, no side effects, complications, contraindications, or drug
dependence were identified.
The studied ready-made form of СHONLUTEN® is convenient for hospitals, outpatient, and home
treatment.
СHONLUTEN® can be used for therapeutic and prophylactic purposes in the form of a biologically
active food supplement and in combination with any means of symptomatic and pathogenetic therapy
used to treat chronic bronchitis.

CONCLUSION
Biologically active food supplement СHONLUTEN® has a normalizing effect on the functional activity
of the bronchial mucosa epithelial cells, helps restore the lungs’ defense mechanisms, and regulates
bronchial quality.
СHONLUTEN® is well tolerated when taken orally, has no side effects, and can be used as a biolog-
ically active food supplement for therapeutic and prophylactic purposes.
СHONLUTEN® is recommended to patients with chronic non-obstructive bronchitis. It is administered
orally 10-15 minutes before meals, 3 tablets 3 times a day for 15 days.
It is recommended to repeat the course of treatment in 3-6 months.
It is advisable to recommend СHONLUTEN® for therapeutic and prophylactic use and industrial
production.

REFERENCES
1. Belousov Y.B., Moiseev V.S., Lepakhin V.K. Clinical Pharmacology and Pharmacotherapy: A Guide
for Physicians. - M .: the Universe, 1993 .-- 398 p.
2. Mashkovsky M.D., Medicines: Pharmacotherapy for doctors, manual: 2 parts. – Vilnius: ZAO “Gamta”,
1993.
3. Paleev N.R., Tsarkova L.N., Borokhov A.I. Chronic nonspecific lung diseases. - M .: Medicine, 1985
.-- 240 p.
4. Tsarkova L.N., Ilchenko V.A. Chronic nonspecific lung diseases / Diagnostics and treatment of internal
diseases: A guide for doctors. Ed. F.I. Komarova. - M .: Medicine, 1991. - T. 2. - S. 106-250.
Сhonluten

RECOMMENDATIONS FOR USE


СHONLUTEN® is recommended to normalize and correct pathological changes in the lungs resulting
from various diseases, also during intensive sports. It is effective for maintaining the function of the
respiratory system in elderly and senile people.
СHONLUTEN® is well tolerated by patients, and there were no side effects, complications, contrain-
dications, or drug dependence observed.
Adults are advised to take 1-2 capsules 1-2 times daily with meals. The duration of admission is 10-30
days. It is advisable to repeat the course in 4-6 months.
Expiration date: 5 years from the date of manufacture.

Responsible executor: A.A. Veretenko

Deputy Director of the LLC «Medical Center of the St.


Petersburg Institute of Bioregulation and Gerontology,
SZO RAMS» for clinical work, Candidate of Medical
Sciences (PhD in Medical Science), Associate Professor

Executor: O.U. Raigorodsky

Chief Physician of the LLC «Medical Center of


the St. Petersburg Institute of Bioregulation and
Gerontology, SZO RAMS», Candidate of Medical
Sciences (PhD in Medical Science)

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