Hairloss Cream002

Medicine Update 2008; 15(9): 31-34
Clinical evaluation of herbal Hair Loss Cream

in management of Alopecia aerata: An open study
G. Ravichandran, M.D.,D.D., M.Derm., Consultant Dermatologist,
Avilochan Singh, Ayurvedic Consultant
Spectra, Clinical Research Wing of Apollo Hospitals,
Apollo Hospitals, Chennai, India.
Pralhad S. Patki*, M.D.,
Head - Medical Services and Clinical Trials
S.K. Mitra, M.D., Executive Director
R&D Center, The Himalaya Drug Company, Bangalore, India.
*Corresponding Author
ABSTRACT
This preliminary study focuses on the effect of a topical application of herbal Hair Loss
Cream, in the reduction of hair loss and promotion of new hair growth in men and women.
Twenty subjects (15 men and 5 women), with varying levels of hair loss, were enrolled in this
six month study. This study indicates that herbal Hair Loss Cream is effective in reducing
hair loss in both men and women: 54% of the male and 52% of the female participants
reported a noticeable decrease in hair loss after one month of treatment. 67% of men and 63%
of women reported significant fall in the hair loss by three months of treatment. By the end of
the study majority of men and women reported new growth of hair.
This study also suggests that herbal Hair Loss Cream may be beneficial in stimulating new
hair growth. This effect, however, seems to be more pronounced in men and women under
the age of 40 years, who are expected to have normal hair growth cycles. Nevertheless, as
most of the subjects of this study have been diagnosed with alopecia, this result suggests that
a subsequent study should be performed to determine quantitatively the effect of herbal Hair
Loss Cream in stimulating hair regeneration in patients with severe alopecia.
INTRODUCTION
Androgenetic alopecia or male pattern baldness is a common condition affecting
approximately 50% to 80% of Caucasian men and is the most widespread form of baldness.
Alopecia is an inherited condition, most likely dominantly inherited with variable penetrance,
which progressively appears as men age1. Typically, 30% of Caucasian men in their thirties
have alopecia. This number increases to 40% for men in their forties, and so on, up to 80% of
men in their eighties and older. This progressive rate of appearance of alopecia is also found
in other ethnicities, although in total, baldness may appear at a lower rate than in Caucasian
men. For example, it is estimated that only a total of 30% to 40% of Asian men are affected
by androgenetic alopecia.
Although not often appreciated, alopecia is also present in a significant portion of women. It
is estimated that 20% to 40% of women have this condition, although not with the same
severity as men2. In women, hair loss typically begins in their twenties to forties, and does
continue to progress with increasing age.
1
It has been suggested that androgenetic alopecia is linked to the activity or concentration of
enzymes, such as the 5-alpha-reductase which makes a potent form of testosterone called
dihydrotestosterone (DHT), in the scalp and hair follicles, or to the sensitivity of hair follicle
receptors to DHT3. Indeed, medications for Androgenetic alopecia concentrating on blocking
the activity of 5-alpha-reductase have been developed, with varying degrees of success and
sometimes with the presence of serious side effects4. As it has proven difficult to regenerate
hair in alopecia patients, attention has also been focused on stopping the hair loss in the first
place. In this preliminary study, we investigate the effectiveness of a topical herbal Hair Loss
Cream application consisting of extracts of Butea monosperma and Butea parviflora in
preventing hair loss and promoting new growth of hair in men and women.
Aim of the Study

This study was planned to evaluate the clinical efficacy and safety of Hair Loss Cream in the
management of alopecia aerata.
Study Design
This study was an open, phase IV clinical trial, conducted at the Department of Dermatology
of Apollo Hospitals, Chennai, India, from November 2004 to December 2005.
The study protocol, case report forms, product information, and informed consent forms were
approved by the local ethics committee.
MATERIALS AND Table 1: Demographic data of patients on entry

METHODS Number of patients 20
Twenty alopecia patients Male, Female Male: 15; Female: 5
composed of 15 males and 5 Diet Vegetarian: 15; Mixed: 5
females were enrolled in the Mean age Male: 39.5 ± 6.9 years
study. The subjects ranged in Female: 31.5 ± 2.9 years
age between 21 and 71 years, Mean serum creatinine (mg%) 0.67± 0.2
with the mean age of 39.5 ± Number with abnormal thyroid Nil
6.9 years for the male function tests
subjects and 31.5 ± 2.9 years
Hair Loss Grade Male Female
for the female subjects.
Problems Severe 4 1
Although most of the
(No. of Medium 6 2
subjects have not exhibited
patients) Mild 5 2
severe alopecia, all reported
hair loss with varying degrees of severity, as shown in Table 1.
Hair loss severity is defined as mild if the subject estimates that daily hair loss is less than 40
strands per day; medium if it is between 40 and 100 strands per day; and severe if it is more
than 100 strands per day5. The subjects were given the topical herbal Hair Loss Cream for a
total study period of 6 months. All the patients were advised to apply sufficient quantity of
Hair Loss Cream to the affected area of scalp, daily, at night, for a period of six months, with
gentle massage, and were advised to leave the cream overnight and left to dry naturally
without blow drying or toweling. The subjects were given a weekly questionnaire to
determine qualitatively the status of their hair loss and new hair growth, as well as the
presence of side effects.
2
Exclusion Criteria:
1. History of systemic or cutaneous malignancy
2. Nevi or cutaneous lesions currently
3. Evidence of immunocompromised state
4. Advanced or poorly controlled diabetes
5. Unstable cardiovascular disease
6. Clinically significant medical or psychiatric disease
7. History of alcohol or drug abuse within two years of assessment for study enrollment
8. Serious local infection (e.g. cellulites, abscess) or systemic infection (e.g. pneumonia,
septicemia) within three months prior to the first dose of investigational drug.
Primary and Secondary Endpoints

The predefined primary efficacy endpoints were improvements in the subjective and
objective score. The subjective evaluation was done using global evaluation scores (0=poor,
1=fair, 2=good, and 3=excellent). The objective improvement evaluation included: (1) Mean
number of hair lost during one minute combing test (>150 hairs lost=poor, 100-150 hairs
lost=fair, 50- 100 hairs lost=good). The secondary end point was adverse effects reported by
the patients.
Statistical Analysis
Statistical analysis was done according to intent-to-treat principles. Changes in various
parameters from baseline values and values after 1, 2, 3, 4, 5, and 6 months were analyzed by
the “Repeated Measures ANOVA test”, The minimum level of significance was fixed at 99%
confidence limit and a 2-sided p value of <0.05 was considered as significant.
RESULTS AND DISCUSSION

The overall result of this preliminary study suggests that even a short-term treatment with
herbal Hair Loss Cream is effective in significantly reducing hair loss and may stimulate new
hair growth in a portion of the subjects. There was a significant reduction in the hair
symptoms (itching, irritation and dryness of the scalp) within 2 weeks, and by the end of
fortnight, all these symptoms disappeared. There was a significant improvement in the tensile
strength of hair as judged by the pull test and combing test. (Table 2)
Table 2: Mean number of hair loss in Combing test

1 month after 3 months after At
Parameter Base line
treatment treatment 6 months
Mean hair loss (/combing) 118.2 ± 6.2 79.2 ± 12.4* 60.4 ± 19.4* 45.5 ± 12.4*
Perceptible Male - 54% 67% 72%
reduction in hair Female - 52% 63% 70%
loss by patients
(%)
*p<0.01 as compared to baseline parameter
Prevention of hair loss

A significant portion of the male and female subjects reported noticeable and significant
reduction in hair loss even after only a short treatment period. After one month of treatment,
over 54% of the male and 52% of the female participants noted a perceptible reduction in
shedding or hair loss. After 6 months of treatment, majority of the subjects reported near
complete elimination of hair loss. Upon closer inspection, it is apparent that older men (i.e.
40 years of age or older) showed a delayed reaction to herbal Hair Loss Cream. This group is
3
of particular interest, as alopecia in
Asian men often starts to manifest
after reaching middle age.
Stimulation of new hair growth

In addition to the weekly
qualitative evaluation of their hair
loss, the subjects were asked to
assess whether there was
noticeable new hair growth after
herbal Hair Loss Cream treatment.
None of the subjects reported any
noticeable new hair growth in the Figure 1: Mean hair loss in Combing test
first week. Majority of men
reported new hair growth by the
end of the study. Although it
seems that herbal Hair Loss Cream
treatment resulted in noticeable
hair growth in both males and
females, it should be noted that
these generally occur in younger
ones.
Serious side effects

Participants of this study were
asked to evaluate the presence of
adverse side effects of the herbal
Hair Loss Cream treatment. None
of the patients exhibited any Figure 2: Perceptible reduction in hair loss as reported by the
adverse effect to the hair cream. patients
DISCUSSION
The results indicate beneficial effect of herbal Hair Loss Cream in minimizing hair loss and
helps in generation of fresh crop of new hair if used for a period of six months. It is effective
and safe. Its exact mechanism of action cannot be identified. Butea monosperma has potent
anti inflammatory activity6,7, which could be responsible for decreasing local inflammation
and hence help in hair growth. Its anti fungal activity too may contribute to its efficacy8.
The active ingredients of Butea frondosa are flavones and flavonoids (butrine, isobutrine and
free amino acids), while the active ingredients of Butea parviflora are glycosides9, which
may help in decreasing hair loss. Its acetylcholine esterase inhibitor effect may also
contribute in its beneficial effects10.
In an experimental study, the effect of “Hair Loss Cream (PCPB Hair Cream)” was evaluated
in chemotherapy-induced alopecia in cell line model. Synchronized hair cycle were treated
with cyclophosphamide, which resulted in complete alopecia followed by hair regrowth11. It
is possible that the clinical effect is a synergistic effect.
4
CONCLUSION
Herbal Hair Loss Cream is a safe and effective in prevention of hair loss. It helps in
regeneration of new hair by six months.
ACKNOWLEDGEMENT
We are thankful to Dr. Rangesh Paramesh M.D(Ay) for the NLQGKHOSRIIHUHG for this project.
References
1. Ellis, J.A., Harrap, S.B. The genetics of androgenetic alopecia. Clin. Dermatol. 2001;
19: 149-154.
2. Birch, M.P., Lalla, S.C., Messenger, A.G. Female pattern hair loss. Clin. Expt
Dermatol. 2002; 27: 393-398.
3. Takashima, I., Montagna, W. Studies of common baldness of the stump-tailed macaque
(Macaco speciosa). VI. The effect of testosterone on common baldness. Arch.
Dermatol. 1071; 103: 527-534.
4. Khandpur, S., Suman, M., Reddy, B.S. Comparative efficacy of various treatment
regimens for androgenetic alopecia in men. J. Dermatol. 2002; 29(8): 489-98.
5. Van Neste. Natural scale hair repression in preclinical stages of male androgenetic
alopecia. Skin Pharmacology and Physiology 2006; 19: 168-176.
6. Shahavi, V.M., Desai, S.K. Antiinflamamtory activity of Butea monosperma.
Fitoterapia 2008; 79: 82-85.
7. Yadava, R.N., Tiwari, L. New antifungal flavane from Butea monosperma. J. Enzyme
Inhib. Med. Chem. 2007; 22: 497-500.
8. Kuntze, O., Yadava, R.N., Tiwari, L. A potential antiviral flavone glycoside from the
seeds of Butea monosperma. J. Asian Nat. Prod. Res. 2005; 7: 185-188.
9. Shah, K.G., Baxi, A.J. Phytochemical studies and antioestrogenic activity of Butea
frondosa flowers. Indian J. Pharmaceu. Sci. 1990; 52(6): 272-275.
10. Mukherjee, P.K., Venkatesan Kumar, Mainak, Houghten, P.J. Acetylcholine esterase
inhibitors from plants. Phytomedicine 2007; 14: 289-300.
11. Evaluation of the efficacy of PCPB Hair Cream in chemotherapy induced alopecia in
cell line model. Data on file.
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Medicine Update 2008; 15(9): 31-34

Clinical evaluation of herbal Hair Loss Cream

Aim of the Study

MATERIALS AND Table 1: Demographic data of patients on entry

Primary and Secondary Endpoints

RESULTS AND DISCUSSION

Table 2: Mean number of hair loss in Combing test

Prevention of hair loss

Stimulation of new hair growth

Serious side effects

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