Journal of Medicinal Plants Research Vol. 5(17), pp.

4094-4098, 9 September, 2011

Available online at http://www.academicjournals.org/JMPR
ISSN 1996-0875 ©2011 Academic Journals

Full Length Research Paper

Clinical study on the management of obesity with

certain natural medicine
Riaz Ur Rehman1,2, Khan Usmanghani2, Halima Nazar2, Shahab uddin2, M. Akram2*,
H. M. Asif1,2 and Zahoor U. l. Hasan2
1
College of Conventional Medicine, Faculty of Pharmacy and Alternative Medicine, the Islamia University of Bahawalpur,
Pakistan.
2
Shifa Ul Mulk Memorial Hospital, Hamdard University Karachi, Pakistan.
Accepted 4 July, 2011

To study the therapeutic effect of herbal medicine in comparison with allopathic medicine for
management of obesity. One hundred patients with obesity were randomly assigned into two groups,
50 in each group. Test group was treated with herbal medicine and control group was treated with
allopathic medicine; Sibutramine. Body mass index, waist circumference and triceps skin fold were
measured before and after treatment. Comparison of data recorded by physician relating to these
variables, showed significant differences between test and control groups (p < 0.05). The efficacy of the
test treated medication (Debese) was superior as p = 0.03. Debese is more effective than the
Sibutramine in the management of obesity.

Key words: Obesity, debese, sibutramine.

INTRODUCTION

Obesity is a medical condition in which excess body fat
has accumulated to the extent that it may have an
adverse effect on health, leading to reduced life
expectancy and/or increased health problems. Body
mass index (BMI), a measurement which compares
weight and height, defines people as overweight when
2
their BMI is between 25 and 30 kg/m and obese when it
2
is greater than 30 kg/m (Adam and Murphy, 2000;
Haslam and James, 2005). Obesity increases the
likelihood of various diseases, particularly heart disease,
type 2 diabetes, breathing difficulties during sleep, certain
types of cancer and osteoarthritis.
Obesity is most commonly caused by a combination of
excessive dietary calories, lack of physical activity and
genetic susceptibility, although a few cases are caused
primarily by genes, endocrine disorders, medications or
psychiatric illness.
A sedentary lifestyle plays a significant role in obesity.
Worldwide there has been a large shift towards less
physically demanding work and currently at least 60% of
the world's population gets insufficient exercise. This is
primarily due to increasing use of mechanized
*Corresponding author. E-mail: makram_0451@hotmail.com.
transportation and a greater prevalence of labor-saving
technology in the home. Certain medications may cause
weight gain or changes in body composition; these
include insulin, sulfonylureas, thiazolidinediones, atypical
antipsychotics, antidepressants, steroids, certain
anticonvulsants (phenytoin and valproate), pizotifen, and
some forms of hormonal contraception (Houghton and
Hoult, 1995; Shick and Wing, 1998). Appropriate goals of
weight management emphasize realistic weight loss to
achieve a reduction in health risks and should include
promotion of weight loss, maintenance and prevention of
weight regain.
MATERIALS AND METHODS
Study design
This is a case control, direct unicenter evaluation based study,
conducted on patients living in the Gadap Town adjacent Madinat-
al-Hikmah, Hamdard University Shifa-ul-Mulk Memorial Hospital
Karachi, Pakistan. The subjects were selected by simple random
sampling technique. Patients with complaint of obesity were
registered. Detailed history was taken from every patient and only
those who were willing to give written consent and would fulfill the
inclusion criteria were selected. The medical ethics committee of
Faculty of Eastern Medicine, Hamdard University Karachi,
approved this study.

Table 1. Body mass index in total patients after treatment.
Complaint at base line
Test (Debese) Control (sibutramine)
Complete improvement < 30 kg/m 2
Body mass index Slight improvement 30-32 kg/m2
Total
90% of patients had complete improvement using debese and 74% of patients using sibutramine had complete improvement.
Patients and dosage form design
A well defined group of patients with symptoms of obesity were
anthropometrically diagnosed and where it was necessary,
laboratory examinations were done to diagnose and treat mild
complications. The sample (n = 100) was selected from the patients
enrolled and on the basis of inclusion and exclusion criteria the
patient marked as candidates were selected. The study period was
for 2 years (July 2008 to July 2010). Among this population the
entire patients were interviewed and upon their consent to
participate they were randomly grouped as case and control
groups. Test group: The test groups were administered coded
natural (Herbal) formulation debese that comprises of different
herbal medicaments. Control group:
The control groups were administered Allopathic drug
Sibutramine for the treatment of obesity. The mean age of patients
prescribed by the debese (test) was calculated to be 27.41 and
26.10 years in males and females, respectively. The mean age of
patients prescribed by the sibutramine (control) was calculated to
be 26.60 and 28.45 years in males and females, respectively.
Primary analysis was based on body mass index. The patients
were considered obese if the body mass index >30 and were
administered debese at a dose of 2 tablets, twice daily for a period
of 3 months. Repeated body mass index was conducted monthly
and the therapy was continued for 6 months. Body mass index,
waist circumference and triceps skin fold were primarily evaluated.
In this study, an attempt has been made to explore the
performance of herbal (test drug) and authentic allopathic (control)
medicine so as to asses their efficacy. Consent of the patients was
taken at the first examination; height and weight were measured for
the calculation of BMI and the standard clinical trial performa was
filled for registration. Different parameters that is, age, duration and
other clinical sign and symptoms were studied and compared
between two groups at base line and end of therapeutic
applications. Coded herbal formulation debese contains Cassia
angustifolia, Cuminum cyminum (Flegel and Johnson, 1998;
Serdula and Galuska, 1999), Nigella sativa, Trachyspermum ammi
(Ramadan, 2007).
A comparative study was conducted for herbal coded formula-
tion debese with allopathic medicine sibutramine. Altogether, 100
patients who had fulfilled the exclusion and inclusion criteria were
administered the test and control drug and similarly were monitored
for follow up. The patients’ gender, age and baseline clinical
features at the time of enrolment were recorded in both groups.
Half of the patients were treated with coded herbal formulation
Debese and remaining half with sibutramine administered orally.
Statistical analysis
The data was adjusted based on the number of cases in the light of
demographic factor using statistical methods like multinomial
logistic regression. Statistical analysis was performed using SPSS
(version 17) and using excels software; the Chi Square and Fisher
Rehman et al. 4095
Treatment groups
Total (n) p value
45 90%) 37(74%) 82
5 (10%) 13 (26%) 18 0.037
50 50 100
exact test were applied. All differences were considered statistically
significant by generating a p value from test statistics. The
significant result with p value’ less then 0.05 was defined as
statistically significant.
RESULTS
According to the statistical analysis (Chi-square test), a
significant difference was observed between two treated
groups (p<0.05) at the end of the therapy. After treatment
test group (debese) showed 90% improvement when
compared with the control (Sibutramine) 74%
improvement in body mass index. After applying the test
of significance there was significant difference between
these two drugs. Chi-square test was applied and p-value
was calculated as 0.03 as shown in (Table 1 and Graph
1).
Waist circumference, after treatment in test and control
group showed, that test group (Debese) has 87.5%
improvement when compared with control (Sibutramine)
29.72% improvement as shown in (Table 2 and Graph 2).
Triceps skin folder, after the complete follow-up in test
group out of 50 patients 46 patients recorded <15 mm
and only 04 patients recorded >20 mm. Whereas in
control group, out of 50 patients 38 patients recorded <15
mm and 12 patients recorded >20 mm. After applying the
Chi-square test and Fisher’s exact test, the p value
calculated was less than 0.05.This showed that there
was a significant difference between these two drugs as
shown in (Table 3 and Graph 3).
DISCUSSION
Clinical trials of anti-obesity drugs reveal significant
degrees of success. The genus Cassia, with Cassia
acutifolia Del or Cassia angustifolia Vahl as the official
species, is generally accepted in the British
pharmacopoeia to consist of members possessing strong
purgative activities (Dziedzic and Hudson, 1984). The
properties and applications of all Cassia species are
similar, though they differ from those of Indian senna (C.
angustifolia Vahl) or Alexandria senna (C. acutifolia Del.)
in that they possess the active components at lower
concentrations (Obiorah, 1982; Ayim, 1986; Kinjo et al.,
1994; Pamplona-Roger, 1999). C. cyminum Linn. is a
4096 J. Med. Plant. Res.

50

40

30
Complete improveme nt
20 Slight improveme nt
10

0
De bes e Sibutra mine
Graph 1. Body mass index by use of sibutramine and debese.

Table 2. Waist circumference in total patients after treatment.

Treatment groups
Complaint after treatment Total (n) p value
Test (debese) Control (sibutramine)
Improved 35 (87.5%) 11 (29.73%) 46
Waist circumference Not improved 05 (12.5%) 26 (70.27%) 31 0.000
Total 40 37 77
87.5% of patients prescribed debese had complete improvement and 29.7% of patient prescribed sibutramine had complete
improvement.

35
30
25
20
Improved
15 Not improved
10
5
0
Debese Sibutramine
Graph 2. Improvement in waist circumference (debese and sibutramine).

small and thin annual herb, grown extensively in south-
east Europe and north Africa bordering the
Mediterranean sea. It is an effective gastric stimulant,
beneficial in abdominal lump and flatulence. It has thera-
peutically been used as an anti-obesity, galactagogue,
diuretic and also beneficial in hoarseness of voice
(Zargari, 1989). Nigella sativa Linn (N. sativa) commonly
known as black seed or black cumin, is an annual herb
from the botanical family of Ranunculaceae. The seeds
of the plant have been used in the southeast Asia, middle
and far east as a natural remedy to treat many diseases,
including asthma, hypertension, diabetes,
hypercholesterolemia, inflammation, arthritis, tumor,
gastrointestinal disturbances and gynecological disorders
for over 2000 years (Ali and Blunden, 2003; El-Din et al.,
2006; Ramadan, 2007). Sibutramine hydroc-hloride
monohydrate is a white to off-white crystalline powder or
white cream crystalline powder, insoluble in water and
soluble in grain alcohol. Sibutramine is an orally
administered agent for treatment of obesity. Sibutramine
is used together with a reduced-calorie diet to lose
weight. Sibutramine is thought to work by increasing the
activity of certain chemicals, called norepinephrine and
serotonin, in the brain. Sibutramine is administered once

Table 3. Triceps skin fold in total patients after treatment.
Treatment groups
After treatment
Test (debese)
>20 mm 04
Triceps skin fold <15 mm 46
Total 50
50
40
30
20
10
0
Debese Sibutramine
Graph 3. Triceps skin fold in total patients after treatment.
daily in obese patients but it exerts side effects like
tachycardia and hypertension. In order to overcome this
problem, there is a great need to find new medicinal
agents that have good efficacy and less adverse effects.
The different herbs used in this study were selected on
the basis of their traditional use in Unani system of
medicine. For example C. angustifolia and C. cyminum
are used to treat obesity and inhibit adipose tissue
growth (Flegel and Johnson, 1998; Serdula and Galuska,
1999).
This unicenter trial has been conducted, for comparing
the efficacy and safety of two different treatment
modalities and has shown greater efficacy of coded
herbal formulation debese as test drug and allopathic
treatment sibutramine administered as control drug for
the treatment of obesity.
In trial effects of debese 500 mg tablet twice daily
compared to sibutramine 10 mg tablet once daily was
investigated on a total of 100 patients suffering from
obesity. Debese is more efficacious in reducing the body
mass index than sibutramine. Reducing body mass index
was due to antiobesity effect of Debese because Debese
contains Cassia angustifolia and Cuminum cyminum
which acts as active ingredients and has antiobesity
effect and other ingredients of debese also have
antiobesity and antihyperlipidemic effect (Zargari, 1989).
Tolerance was generally good and side effects were not
observed in test group.
Rehman et al. 4097
Total (n) P value
Control (sibutramine)
12 16
38 84 0.026
50 100
>20
<15mm
Conclusion
Debese is more effective than sibutramine in the
management of obesity as determined by p value <0.03.
Therefore, control drug showed lesser efficacy than the
test drug in its compliance to treat obesity. The control
drug exhibited side effects like gastrointestinal intole-
rance, nausea and vomiting, where the test drug did not
display or show any untoward manifestation associated
with the use of this medication and found acceptability by
all treated patients.
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