Evaluation of clinical efficacy ofAyurSlim on body weight, body massindex, lipid profile and skin foldthickness: 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 inmanaging 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 andtolerability of a herbal preparation known as AyurSlim in a dosage of 2 capsules, twice daily forsix months. Physical, chemical and pathological investigations were carried out on day one andthen on the first day of every month for six months. Over the period of six months, they wereevaluated for efficacy and tolerability to AyurSlim. The objective of the study was to test theefficacy of AyurSlim by checking the bodyweight, body mass index, lipid profile and skin foldthickness. Results showed that AyurSlim was effective in weight reduction in all the patientsclinically in addition to decrease in skin fold thickness and lipid profile, though statistically bodymass index, did not decrease significantly. There were no untoward reactions in any of the patients.
INTRODUCTION

Obesity has become a major publichealth problem mainly due to improper
eating habits and physical inactivity.
It has been recognized as aheterogenous group of disorders
rather than a single disorder that isaccompanied by an increased risk ofmorbidity and mortality. By definition,
obesity exists when adipose tissuecomprises a greater-than-normal
fraction of total body weight. It canbe assessed in terms of height andweight, and weight can be related toheight and age. An alternative methodof estimating obesity is the body massindex or BMI (optimum BMI 19-25).
The degree of adiposity can beassessed by skin fold thickness invarious areas of the body together
Dr. A.K. Singh#, M.D.
Institute of Post-graduate Education and Researchin 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 desirablefrom the health point of view, suchas fat deposits around the waist andflank as evidenced by a high ratio ofwaist-to-hip circumference, which is
associated with a greater health risk
than fat deposition at the hips. The
Framingham study demonstrated thata 20% excess over desirable weightclearly imparted a health risk. Whenenergy intake exceeds expenditure,
the excess calories are stored inadipose tissue and this net positivebalance results in obesity. Obesity is
associated with many hazards and isrecognized 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 ofagents have been evaluated for theirefficacy and safety in the managementof obesity. Amphetamines have a welldefined abuse potential and drugs
like diethylpropion and fenfluramine
cause
appreciable
undesirable
symptoms related to depression andpulmonary hypertension. There is aneed of a safer and effective drug toTHE ANTISEPTIC

manage obesity. Recently a herbal
anti obesity formulation has been
made available. The objective of thisstudy was to know the effect of thisherbal drug AyurSlim on bodyweight, body mass index; lipid profileand skin fold thickness.
MATERIALS AND METHODS

A phase IV open clinical trial wasconducted in Institute of Postgraduate Education in Ayurved,
Shamadas
AyurvedVidyapeet,
Kolkata, India. This trial was approvedby the ethical committee of thehospital. Forty two obese patients ofeither sex, who were 20% more thanthe desirable body weight in the agegroup of 20-45 years, were enrolled
in the study. Thirty two patientscompleted the trial. Patients withpregnancy, genetic disorders, familial
hyper-triglyceridemia,
secondaryobesity due to endocrine or othercauses and patients with severe
cardiovascular, renal or liver disorderswere excluded from the study. Thepatients were administered AyurSlim
in a dose of 2 capsules, twice dailyfor 6 months.
Skin fold thickness (left triceps,subscapular, mid axillary) was241

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

The present study was conducted
on 32 cases (4 males, 28 females).
Weight reduction was reported
among all patients and was foundmore in the first 3 months. Severely
obese patients had greater reduction
when compared to over weightpatients. The mean body weightdecreased statistically from 76.6 ± 6.2
to 68.2 ± 2.4 kg (Table 1 and Figure1). The mean BMI decreased from36.00 ± 3.63 to 33.6 ± 3.85, thedifference
being
statisticallyinsignificant (Table 1 and Figure 2).
The mean skin fold thickness triceps
showed a significant decrease but
the difference was statisticallyinsignificant in case of subscapularand mid axillary areas (Table 2 andFigure 3). The mean serum cholesterol,triglyceride and LDL had significant
decrement at the end of the study(Table 3 and Figure 4). There was noappreciable change in HDL (Table 3and Figure 4).

Table 1: Effect of AyurSlim on BMI and Body weightParameter

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

TricepsSkin fold28.33 ± 2.36

25.80 ± 2.87

0.01

Subscapular

33.22 ± 9.90

32.11 ± 9.77

NSMid axillary

32.52 ± 10.83

31.33 ± 10.29

NSTable 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

NSLDL

166.89 ± 47.50

102.74 ± 41.29

NSFigure 1: Effect of AyurSlim on Mean Body WeightDISCUSSION

Obesity is a major nutritional
disease associated with a wide rangeof chronic debilitating and life
threatening conditions. Morbidly
obese individuals (>200% ideal bodyweight) have as much as twelve foldincrease in mortality. Mortality rates
rise as obesity increases particularly
when obesity is associated withincreased abdominal fat. Obesity
develops over a period of time andonce developed is difficult to treat.
Obesity has associated morbidities
such as hypertension and diabetes,
hyperlipidemia is implicated incoronary heart disease and risk ofgall bladder disease is increased.
Endocrinal changes with obesity areassociated with metabolic diseases
and infertility.
It is therefore important toemphasize that weight loss isimportant in disease management andto 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 toskepticism.
Many
approaches
produce short-term weight loss.
Sustained weight loss is uncommon.
Besides, short-term benefits ofmedication like anorexic drugs thatinduce weight loss are often
associated with rebound weight gain
after cessation of drug use, besides
which their side effects and thepotential for drug abuse add to thelimitations of the drugs.
AyurSlim is an herbal formulation
comprising
powdersofBalsamodendron mukul and extractsof Garcinia cambogia, Gymnema
sylvestre, Terminalia chebula andTrigonella foenum graecum. Garcinia
cambogia (Garcinia, Kokam) limits thesynthesis (manufacture) of fatty acidsin the muscles and liver and thusarrests lipogenesis (production of fat)by inhibiting the enzyme ATP-citratelyase. With no further synthesis, theexisting fatty acids are gradually
metabolised, resulting in reduction ofbody weight.1,2 It does not alter serum
sex hormone levels and blood
parameters.3 It is regarded as one ofthe plants with potent antidiabetic
andantiobesity
effect.
Balsamodendron mukul reducescholesterol and triglyceride levels,
factors
concerned
withthemanagement 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 theproperty of abolishing the taste ofsugar and neutralising excess sugarpresent 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 havedocumented the potent hypolipidemic
activity of Terminalia chebula.6
Trigonella foenum graecum(fenugreek) has potent antidiabeticactivity.
Insulinresistance(hyperinsulinaemia) is now recognized
as a major contributor to thedevelopment of glucose intolerance,
dyslipidaemia and hypertension in
non-insulin-dependent
diabetes
mellitus (NIDDM) patients. Variousstudies 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
glycogenresynthesis,
therebynormalizing the energy metabolism inthe physiological milieu6. Treatment
with Trigonella foenum graecum wasalso found to lower serum and tissue
lipid levels in streptozotocin (STZ)induced diabetic rats.7,8Clinical trials conducted withAyurSlim have shown significant
effect in reducing body weight andlipid levels. It is possible that theeffect seen with AyurSlim is a sum
total effect of its ingredients.
CONCLUSION

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

There was appreciable change in theBMI, skin fold thickness and serum
lipid parameters in this short-term
study. It is possible that the drug has
more beneficial effects when used fora longer period.
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