Evaluation of Safety Profile of Homoeopathic Mothe
Evaluation of Safety Profile of Homoeopathic Mothe
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I J R H
ORIGINAL ARTICLE
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Surender Singh, Rohit Kumar, Ritu Karwasra, Prerna Kalra, Shalu Rani,
Debadatta Nayak1, Y. K. Gupta
Methods: Toxicity studies were conducted to assess the level to which substances are Received: 30‑05‑2013
Accepted: 16-05-2014
toxic for humans and animals. In acute oral toxicity study, different homoeopathic mother
tinctures were administered orally (a single dose of 4 ml/kg)and animals were observed
for toxic symptoms till 14 days as per OECD (Organisation for Economic Co-operation
and Development) - 423 guidelines. For sub-acute toxicity study, 28 day oral toxicity
of mother tinctures (4 ml/kg daily) was carried out according to the OECD guidelines
for testing of chemicals - 407. At the end of 28 days, the animals were sacrificed and
toxicity was assessed on parameters such as blood, biochemistry and histopathology.
Results: Results indicate that there were no toxic symptoms observed in tested
animals. Results of sub-acute toxicity study did not show any change in body
weight, haematological and biochemical parameters as compared to control. The
histopathological examination of kidney and liver also did not reveal any organ toxicities.
safety profile is not evaluated[4] or they have toxic were manufactured according to the Homoeopathic
effects, e.g. Ricin a constituent from Ricinus communis is Pharmacopeia of India.[6]
the most poisonous naturally occurring substance, one
Dose calculation
seed of which can cause even death.[5] Hence plants
Recommended dose given for rats is 40 µl/100 g
can prove to be a major boon to pharmaceuticals, if
body weight (400 µl/kg body weight), per orally
their safety profiles are properly assessed.
with de‑ionised water (360 µl) as vehicle for
However, safety still remains a challenge because administration.
of the high variability of chemical components
involved. Various homoeopathic mother tinctures Acute toxicity Study
were selected based on the earlier provings of Acute oral toxicity test was performed as per
Ricinus communis, Rauwolfia serpentina, Bellis perennis, OECD (Organisation for Economic Co‑operation
Curcuma longa, Terminalia arjuna and Tribulus and Development) ‑423 guidelines. Twelve groups
terresteris conducted by Central Council for Research of male Wistar albino rats (n = 10) were used in
in Homoeopathy. this study (test drugs along with their respective
control). All the animals were randomly
The aim of the present study was therefore to distributed into six control group and six treated
evaluate the toxicity of the mother tinctures viz. groups. Group I received Bellis perennis mother
Ricinus communis, Rauwolfia serpentina, Bellis perennis, tincture (BPMT), Group II received same percentage
Curcuma longa, Terminalia arjuna and Tribulus terresteris of alcoholic solution as of mother tincture (65% v/v)
so as to develop the preliminary safety profile of the which served as control for BPMT, Group III received
mother tinctures. Curcuma longa mother tincture (CLMT), Group IV
received same percentage of alcoholic solution
MATERIAL AND METHODS
as of mother tincture (60% v/v) which served as
Animals control for CLMT, Group V received Rauwolfia
The study was carried out in the Department of serpentina mother tincture (RSMT), Group VI
Pharmacology with the approval of the Institutional received same percentage of alcoholic solution as
Animal Ethics Committee, All India Institute of of mother tincture (77% v/v) which served as control
Medical Sciences (AIIMS), New Delhi (673/IAEC/12). for RSMT, Group VII received Ricinus communis
Adult male Wistar albino rats (150-200 g) from the mother tincture (RCMT), Group VIII received same
Central Animal Facility, AIIMS, were used in the study. percentage of alcoholic solution as of mother
Animals were housed under standard laboratory tincture (94% v/v) which served as control for
conditions at 25 ± 20C in groups with free access RCMT, Group IX received Tribulus terresteris mother
to food and water ad libitum. They were acclimatised tincture (TTMT), Group X received same percentage
to the laboratory conditions for a period of 5 days of alcoholic solution as of mother tincture (62% v/v)
before the study. which served as control for TTMT, Group XI
received Terminalia arjuna mother tincture (TAMT),
Drugs and chemicals Group XII received same percentage of alcoholic
The homoeopathic drugs in the form of mother solution as of mother tincture (82% v/v) which
tinctures, on the request of Central Council for served as control for TAMT. Following the fasting
Research in Homoeopathy, Department of AYUSH, period, the rats were weighed and the dose was
New Delhi were supplied by Dr. Willmar Schwabe calculated in reference to the body weight. For the
India Pvt. Ltd., Noida, India. main test, a single dose of 4 ml/kg body weight of
Selection of homoeopathic mother tinctures each mother tincture was administered to rats in
Homoeopathic mother tinctures that were selected the treatment groups, whereas the control groups
for evaluating the safety profile were Ricinus communis received vehicle (the respective percentage of
(containing 94% v/v alcohol), Rauwolfia serpentina alcohol) at dose of 4 ml/kg body weight by oral
(containing 77% v/v alcohol), Bellis perennis (containing route. Food was provided to the rats approximately
65% v/v alcohol), Curcuma longa (containing 60% v/v an hour after treatment. The animals were observed
alcohol), Terminalia arjuna (containing 82%v/v alcohol) 30 min after dosing followed by hourly observation
and Tribulus terresteris (containing 62% v/v alcohol) for 8 h till 14 days.[7]
1XPEHURIDQLPDOVDOLYH
received normal saline (0.1 ml/10g body weight p.o)
and served as control. Group II received BPMT),
Group III received CLMT, Group IV received RSMT,
Group V received RCMT, Group VI received TTMT
and Group VII received TAMT. Body weight was
recorded on days 1, 7, 14, 21 and 28. At the end
were harvested immediately and organ weights were Figure 1: Effect of administering different mother tinctures on acute oral
measured. The liver and kidney were then fixed in toxicity study for observation period of 14 days
Table 4: Effect of administering different mother tinctures on the blood parameters (RBC, WBC,
platelet count, haemoglobin, bleeding time and clotting time) of Wistar rat for period of 28 days
Haematological parameters
Drug Blood parameters
treatment RBC WBC Platelets Hemoglobin Bleeding Clotting
(milliom/mm3) (thousand/mm3) (lacs/mm3) (g/dl) time (sec) time (sec)
Control 7.78±0.11 17.20±0.17 37.99±0.57 12.53±0.54 834.83±4.23 232.6±3.12
BPMT 7.13±0.22 16.39±0.34 34.81±1.10 11.86±0.31 864.66±5.76 253.4±4.50
CLMT 7.23±0.30 16.89±0.19 35.77±1.47 12.50±0.46 833.66±8.38 245.4±3.75
RSMT 7.22±0.26 16.44±0.19 35.27±1.28 12.42±0.37 859.16±8.20 240.2±3.10
RCMT 7.38±0.28 16.91±0.19 36.07±1.38 12.26±0.65 868.33±11.56 243.5±4.18
TTMT 7.27±0.22 16.52±0.17 35.50±1.11 13.26±0.51 820.16±4.88 238.7±4.20
TAMT 7.43±0.28 17.07±0.22 36.29±1.37 12.90±0.24 836.66±13.94 244.2±3.24
Values are mean±SEM; n=6 in each group, BPMT: Bellis perennis mother tincture; CLMT: Curcuma longa mother tincture; RSMT: Rauwolfia serpentina mother
tincture; RCMT: Ricinus communis mother tincture; TTMT: Tribulus terresteris mother tincture; TAMT: Terminalia arjuna mother tincture; RBC: Red blood cell;
WBC: White blood cell
Figure 2: Photomicrographs were taken at magnification (10X). Pictomicrographs demonstrate no degeneration of the glomerular structure
or interstitium in any of the groups. Thus, no histopathological changes were observed in kidney tissues of treated group when compared with
control group. Group I: Control Group, Group II: BPMT, Group III: CLMT, Group IV: RSMT, Group V: RCMT, Group VI: TTMT, Group VII: TAMT
BPMT: Bellis perennis mother tincture, CLMT: Curcuma longa mother tincture, RSMT: Rauwolfia serpentina mother tincture, RCMT: Ricinus communis mother
tincture, TTMT: Tribulus terresteris mother tincture, TAMT: Terminalia arjuna mother tincture
Figure 3: Photomicrographs were taken at magnification (10X). Pictomicrographs demonstrate well-organised lobular structure, normal hepatic cells with
clear nucleus, well preserved central vein and portal triad in all the treated groups. Thus, appears normal with no changes in liver tissues of treated groups
as compared to control. Group I: Control Group, Group II: BPMT, Group III: CLMT, Group IV: RSMT, Group V: RCMT, Group VI: TTMT, Group VII: TAMT
BPMT: Bellis perennis mother tincture, CLMT: Curcuma longa mother tincture, RSMT: Rauwolfia serpentina mother tincture, RCMT: Ricinus communis mother
tincture, TTMT: Tribulus terresteris mother tincture, TAMT: Terminalia arjuna mother tincture
that these mother tinctures did not have any adverse of the mother tincture treated groups remained
effects on body weight. The organ weights and normal. It reveals that these mother tinctures did not
histopathological examination (liver, kidney, heart) produce any toxic symptoms to these vital organs.
There were no significant changes in any liver function of India for providing financial assistance in the form of
parameters such as aspartate aminotransfrase (AST) collaborative research project.
and alanine transaminase (ALT) levels as compared to
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