Evaluation of clinical efficacy of

AyurSlim on body weight, body mass

index, lipid profile and skin fold
thickness: A Phase IV clinical trial
SINGH A.K., PRALHAD S. PATKI, MITRA S.K.
ABSTRACT

Obesity is a global health problem. Traditional herbal medicines may have some potential in
managing obesity. Thirty-two obese patients of either sex who were 20% more than the desirable
body weight in the age group of 20-45 years, participated in a study to test the efficacy and
tolerability of a herbal preparation known as AyurSlim in a dosage of 2 capsules, twice daily for
six months. Physical, chemical and pathological investigations were carried out on day one and
then on the first day of every month for six months. Over the period of six months, they were
evaluated for efficacy and tolerability to AyurSlim. The objective of the study was to test the
efficacy of AyurSlim by checking the bodyweight, body mass index, lipid profile and skin fold
thickness. Results showed that AyurSlim was effective in weight reduction in all the patients
clinically in addition to decrease in skin fold thickness and lipid profile, though statistically body
mass index, did not decrease significantly. There were no untoward reactions in any of the patients.
INTRODUCTION

Obesity has become a major public

health problem mainly due to improper
eating habits and physical inactivity.
It has been recognized as a
heterogenous group of disorders
rather than a single disorder that is
accompanied by an increased risk of
morbidity and mortality. By definition,
obesity exists when adipose tissue
comprises a greater-than-normal
fraction of total body weight. It can
be assessed in terms of height and
weight, and weight can be related to
height and age. An alternative method
of estimating obesity is the body mass
index or BMI (optimum BMI 19-25).
The degree of adiposity can be
assessed by skin fold thickness in
various areas of the body together
Dr. A.K. Singh#, M.D.
Institute of Post-graduate Education and Research
in Ayurved
Shamdas Vaidya Shastra Pith, University of Calcutta,
Kolkata-700 009, India.
(#Principal, Subhdeep Ayurved Medical College,
Indore-452 009, India)
Dr. Pralhad S. Patki, M.D.,
Head - Medical Services and Clinical Trials
Dr. S.K. Mitra, M.D., Executive Director
R&D Center, The Himalaya Drug Company,
Bangalore - 562 123, India.
Specially Contributed to "The Antiseptic"
Vol. 105 No. 5 & P : 241 - 243

May 2008

with height, weight and age. Certain

patterns of obesity are less desirable
from the health point of view, such
as fat deposits around the waist and
flank as evidenced by a high ratio of
waist-to-hip circumference, which is
associated with a greater health risk
than fat deposition at the hips. The
Framingham study demonstrated that
a 20% excess over desirable weight
clearly imparted a health risk. When
energy intake exceeds expenditure,
the excess calories are stored in
adipose tissue and this net positive
balance results in obesity. Obesity is
associated with many hazards and is
recognized as a risk factor in the
aetiology of premature death,
diabetes mellitus, hypertension,
atherosclerosis, gall bladder problems
and certain types of cancer. Inactivity
leads to obesity and vice-versa, thus
forming a vicious circle. A number of
agents have been evaluated for their
efficacy and safety in the management
of obesity. Amphetamines have a well
defined abuse potential and drugs
like diethylpropion and fenfluramine
cause
appreciable
undesirable
symptoms related to depression and
pulmonary hypertension. There is a
need of a safer and effective drug to
THE ANTISEPTIC

manage obesity. Recently a herbal

anti obesity formulation has been
made available. The objective of this
study was to know the effect of this
herbal drug AyurSlim on body
weight, body mass index; lipid profile
and skin fold thickness.
MATERIALS AND METHODS

A phase IV open clinical trial was

conducted in Institute of Postgraduate Education in Ayurved,
Shamadas
Ayurved
Vidyapeet,
Kolkata, India. This trial was approved
by the ethical committee of the
hospital. Forty two obese patients of
either sex, who were 20% more than
the desirable body weight in the age
group of 20-45 years, were enrolled
in the study. Thirty two patients
completed the trial. Patients with
pregnancy, genetic disorders, familial
hyper-triglyceridemia,
secondary
obesity due to endocrine or other
causes and patients with severe
cardiovascular, renal or liver disorders
were excluded from the study. The
patients were administered AyurSlim
in a dose of 2 capsules, twice daily
for 6 months.
Skin fold thickness (left triceps,
subscapular, mid axillary) was

241

assessed at initial visit and at the

end of the study by using the calliper.
Biochemical investigations (Hb, TLC,
DLC, ESR, thyroid profile, random
blood sugar) were done at the initial
visit. Lipid profile was assessed
initially, at 3 months and at the end
of the study.
RESULTS

The present study was conducted

on 32 cases (4 males, 28 females).
Weight reduction was reported
among all patients and was found
more in the first 3 months. Severely
obese patients had greater reduction
when compared to over weight
patients. The mean body weight
decreased statistically from 76.6 6.2
to 68.2 2.4 kg (Table 1 and Figure
1). The mean BMI decreased from
36.00 3.63 to 33.6 3.85, the
difference
being
statistically
insignificant (Table 1 and Figure 2).
The mean skin fold thickness triceps
showed a significant decrease but
the difference was statistically
insignificant in case of subscapular
and mid axillary areas (Table 2 and
Figure 3). The mean serum cholesterol,
triglyceride and LDL had significant
decrement at the end of the study
(Table 3 and Figure 4). There was no
appreciable change in HDL (Table 3
and Figure 4).

Table 1: Effect of AyurSlim on BMI and Body weight

Parameter

Baseline

At the end of study

p value

Mean body weight (kg)

76.6 6.2

67.2 2.4

0.01

BMI

36 3.63

33.59 3.85

NS

Table 2: Effect of AyurSlim on skin fold thickness (mm)

Baseline

At the end of study

p value

Triceps

Skin fold

28.33 2.36

25.80 2.87

0.01

Subscapular

33.22 9.90

32.11 9.77

NS

Mid axillary

32.52 10.83

31.33 10.29

NS

Table 3: Effect of AyurSlim on lipid profile (mg%)

Parameter

Baseline

At the end of study

p value

Serum cholesterol 285.31 29.81

179.89 37.19

0.01

Serum triglyceride 232.73 97.41

111.35 43.86

0.01

HDL

39.94 7.97

40.57 7.63

NS

LDL

166.89 47.50

102.74 41.29

NS

Figure 1: Effect of AyurSlim on Mean Body Weight

DISCUSSION

Obesity is a major nutritional

disease associated with a wide range
of chronic debilitating and life
threatening conditions. Morbidly
obese individuals (>200% ideal body
weight) have as much as twelve fold
increase in mortality. Mortality rates
rise as obesity increases particularly
when obesity is associated with
increased abdominal fat. Obesity
develops over a period of time and
once developed is difficult to treat.
Obesity has associated morbidities
such as hypertension and diabetes,
hyperlipidemia is implicated in
coronary heart disease and risk of
gall bladder disease is increased.
Endocrinal changes with obesity are
associated with metabolic diseases
and infertility.
It is therefore important to
emphasize that weight loss is
important in disease management and
to minimize death from conditions
connected to obesity.

242

Figure 2: Effect of AyurSlim on Body Mass Index (BMI)

THE ANTISEPTIC

May 2008

Treatment of obesity is subject to

skepticism.
Many
approaches
produce short-term weight loss.
Sustained weight loss is uncommon.
Besides, short-term benefits of
medication like anorexic drugs that
induce weight loss are often
associated with rebound weight gain
after cessation of drug use, besides
which their side effects and the
potential for drug abuse add to the
limitations of the drugs.
AyurSlim is an herbal formulation
comprising
powders
of
Balsamodendron mukul and extracts
of Garcinia cambogia, Gymnema
sylvestre, Terminalia chebula and
Trigonella foenum graecum. Garcinia
cambogia (Garcinia, Kokam) limits the
synthesis (manufacture) of fatty acids
in the muscles and liver and thus
arrests lipogenesis (production of fat)
by inhibiting the enzyme ATP-citrate
lyase. With no further synthesis, the
existing fatty acids are gradually
metabolised, resulting in reduction of
body weight.1,2 It does not alter serum
sex hormone levels and blood
parameters.3 It is regarded as one of
the plants with potent antidiabetic
and
antiobesity
effect.
Balsamodendron mukul reduces
cholesterol and triglyceride levels,
factors
concerned
with
the
management of obesity in Ayurveda.
It also assists in burning fat 2.
Gymnema sylvestre, the active
principle of this plant is gymnemic
acid. It is a mild diuretic and has the
property of abolishing the taste of
sugar and neutralising excess sugar
present in the body. It is regarded as
one of the plants with potent
antidiabetic and antiobesity effects.4,5
Terminalia chebula is a potent
antioxidant and anti-inflammatory
herb. Numerous studies have
documented the potent hypolipidemic
activity of Terminalia chebula.6
Trigonella foenum graecum
(fenugreek) has potent antidiabetic
activity.
Insulin
resistance
(hyperinsulinaemia) is now recognized
as a major contributor to the
development of glucose intolerance,
dyslipidaemia and hypertension in
non-insulin-dependent
diabetes
mellitus (NIDDM) patients. Various
studies have documented the antihyperglycemic activity and the herb
May 2008

Figure 3: Effect of AyurSlim on skin fold thickness

Figure 4: Effect of AyurSlim on lipid profile

has been shown to reduce plasma

glucose levels and increase muscle
glycogen
resynthesis,
thereby
normalizing the energy metabolism in
the physiological milieu6. Treatment
with Trigonella foenum graecum was
also found to lower serum and tissue
lipid levels in streptozotocin (STZ)induced diabetic rats.7,8
Clinical trials conducted with
AyurSlim have shown significant
effect in reducing body weight and
lipid levels. It is possible that the
effect seen with AyurSlim is a sum
total effect of its ingredients.
CONCLUSION

The efficacy of AyurSlim was

studied in patients who were obese.
At the end of the study, AyurSlim
was associated with a significant
reduction in body weight of the
patients. The weight loss was directly
proportional to the initial weight.
THE ANTISEPTIC

There was appreciable change in the

BMI, skin fold thickness and serum
lipid parameters in this short-term
study. It is possible that the drug has
more beneficial effects when used for
a longer period.
REFERENCES
1. Berkhout A., Havekes LM, Pearce NJ and Groot PHE. The
effect of (-)-hydroxycitrate on the activity of the lowdensity-lipoprotein receptor and 3-hydroxy-3-methylglutarylCoA reductase levels in the human hepatoma cell Hep
G2. Biochem. J. (1990): (272), 181.
2. Cherniak, E.P. Potential application for alternative
medicine to treat obesity. Altern Med Rev 2008; 13:34-42.
3. Hayamizu, K., Tomi, H., Kaneko, I. Effects of Garcinia
cambogia extract on serum sex hormones in overweight
subjects. Fitoterapia 2008 (In Press).
4. Shigemura, N., Nakao, K., Yasuo, T., Murata, Y. Gurmarin
sensitivity of sweet taste responses is associated with
co-expression. Patterns of T1r2, T1r3 and gustducin.
Biochem Biophys Res Commun. 2009; 367: 356-363.
5. Kanetkar, P., Singhal, R., Kamet, M. Gymnema sylvestre:
A memoir. J. Clin. Biochem. Nutr. 2007; 41: 77-81.
6. Nadkarni, KM. Indian Materia Medica, Popular Prakashan
Pvt. Ltd., Bombay, (1996): (1), 598.
7. Shaila HP, Udupa, SL, Udupa, AL. Hypolipidemic activity
of three indigenous drugs in experimentally induced
atherosclerosis. Int. J. Cardiol. 1998; 67(2):119-124.
8. Annida, B, Stanely Mainzen Prince P. Supplementation
of fenugreek leaves lower lipid profile in streptozotocininduced diabetic rats. J. Med. Food. 2004;7(2):153-156.

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