Clinical Trial Report of Ezi Slim
INTRODUCTION
Obesity is a chronic
condition characterized by access adipose tissue leading to body
at 20% over expected weight arising as a consequence of positive
caloric balance. It is considered the world’s oldest metabolic
disorder. It is not a single disease entity but a syndrome with
many causes including combination of genetic, nutritional and
sociological factors.
The WHO considers obesity a
global pandemic. The nutrition foundation of India had completed
study of the prevalence of obesity in urban Delhi from which it
appears that nearly one third of the males and more than half of
the females belonging to upper middle classes in India are
currently over weight.
AIM AND OBJECTS
Different formulations are
developed to treat obesity. The present clinical trial was
undertaken for –
-
To evaluate the therapeutic value of
capsule “EZI SLIM” a poly herbal formulation prepared by
M/s. Goodcare Pharma Pvt. Ltd, Kolkata – 6, in the
patients of obesity.
-
To evaluate the effect of capsule “EZI
SLIM” on lipid levels of the body to be assessed by bio
chemical study.
-
To observe clinical toxicity or side
effect, if any, during the clinical study.
MATERIALS AND METHODS
Total 66 patients of
obesity were registered during the course of the trial. The
study consists clinical patterns in obesity and management of
the obesity with capsule “EZI SLIM”. In this trial 66 cases
were registered out of which 42 cases had completed the total
tenure of the treatment rest 24 cases had discontinued at
different point of time.
PLACE OF STUDY
The present clinical study
was undertaken at Shyamadas Vaidya Shastrapith Hospital attached
to the Institute of Post Graduate Ayurvedic Education and
Research, Kolkata – 9, during January 2006 to December 2006.
SELECTION OF CASES
All the patients selected
for the present study were interrogated and detail history was
recorded in the case record form. All the patients were
thoroughly examined and findings were recorded. To establish the
final diagnosis the selection criteria as noted below was
followed.
SELECTION CRITERIA
For the purpose of present
study, patients belonging to the age group of 21 – 60 years of
age were selected and the diagnostic criteria was the following.
A) Subjective
Feature
The clinical features as
mentioned in classical Ayurvedic texts regarding obesity (Sthaulya)
were observed in the patients. The following markers were also
observed during diagnosis and assessment.
-
Body weight more than 20% above the ideal
body weight.
-
Ponderal Index less than 12.
-
A fat fold thickness (FFT) greater than
2.5 cm at the tip of scapula in males and mid triceps
regions in females.
-
Grading of obesity based on Body Mass
Index (BMI).
B) Objective
Criterias
The following laboratory
investigations were carried out for diagnosis and differential
diagnosis.
-
Lipid profile
-
Blood sugar (F & PP)
-
Routine Hematological Test
-
Thyroid profile
-
Routine Urine examination
EXCLUSION CRITERIAS
A)
Patients below 20 years and above 60 years of age.
B)
Chronicity less than 10 years.
C)
Diabetes mellitus.
D)
Hypothyroidism.
E)
Cardiac problem.
F)
Renal Disease.
G)
Pregnant women and Lactating mother.
H)
Patients taking other Treatment.
DRUG SELECTED FOR THE STUDY
For the purpose of the
clinical trial “EZI SLIM” capsule, a poly herbal compound
formulated by M/s. Goodcare Pharma Pvt. Ltd., Kolkata – 6,
approved by the Director of Drug Control, West Bengal has been
selected.
METHOD OF DRUG ADMINISTRATION
The present study was
carried out in the patients of obesity in consideration with
inclusion and exclusion criteria. The eligible patients were
randomly divided in two groups, viz.
-
Group – A (trial Group) – to whom the
trial drug (EZI SLIM) was given in the dose of two capsules
twice a day morning and evening with water for a period of
90 days.
-
Group – B (Control Group) – to whom
the placebo capsules (containing sugar of milk) was given in
the similar way like trial group.
FOLLOW UP
Follow up study was
conducted in all cases at interval of 30 days for 90 days. Lipid
profile, blood sugar, routine hematological test, thyroid
profile and routine urine examination was done in each case
before starting the treatment and lipid profile was repeated at
the end of treatment, i.e. after 90 days. All the subjective
criterias, viz. clinical features, body weight, Ponderal Index,
Fat Fold Thickness, BMI was assessed at interval of 30 days for
90 days in all cases.
CLINICAL PATTERN
The present study consists
of total 66 cases who have symptoms of obesity. Among them 42
cases completed the full course of treatment schedule (i.e. 90
days) and 24 cases had not completed the full course of trial.
But the clinical pattern will be discussed in all 66 cases. The
result will be analyzed on observation of the findings of 42
cases.
AGE INCIDENCE
Patients of the present
study were from 21 to 60 years of age> Patients of different
age group are given in Table No. 1.
Table No. 1:
Showing the incidence of different age group
|
Sl. No.
|
Age groups (Years)
|
No. of patients
|
Percentage
|
|
1
|
21 – 30
|
16
|
24.24
|
|
2
|
31 – 40
|
24
|
36.36
|
|
3
|
41 – 50
|
17
|
25.76
|
|
4
|
51 – 60
|
9
|
13.64
|
|
Total
|
66
|
100.00
|
SEX INCIDENCE
Patients of both sexes were
registered for the present study. The sex groups are given in
Table No. 2
Table No. 2:
Showing the incidence of sex
|
Sl. No.
|
Sex
|
No. of patients
|
Percentage
|
|
1
|
Male
|
28
|
42.42
|
|
2
|
Female
|
38
|
57.58
|
|
Total
|
66
|
100.00
|
RELIGION INCIDENCE
Patients of various
religions were included in this study. Patients belonging to
different religion are shown in Table No. 3
Table No. 3:
Showing the incidence of religion
|
Sl. No.
|
Religion
|
No. of patients
|
Percentage
|
|
1
|
Muslim
|
30
|
45.45
|
|
2
|
Hindu
|
32
|
48.49
|
|
3
|
Christian
|
04
|
6.06
|
|
Total
|
66
|
100.00
|
OCCUPATIONAL INCIDENCE
In this study patients
belonging to various occupation were included. The occupation
history as recorded are shown in Table No. 4
Table No. 4:
Showing the incidence of occupation
|
Sl. No.
|
Occupation
|
No. of patients
|
Percentage
|
|
1
|
Service
|
13
|
19.70
|
|
2
|
House wives
|
26
|
39.40
|
|
3
|
Labour
|
2
|
3.03
|
|
4
|
Cultivator
|
6
|
9.10
|
|
5
|
Student
|
4
|
6.05
|
|
6
|
Businessmen
|
12
|
18.18
|
|
7
|
Miscellaneous
|
3
|
4.54
|
|
Total
|
66
|
100.00
|
ECONOMICAL STATUS
INCIDENCE
In this study patients of
different income group were recorded and shown in Table No. 5
Table No. 5:
Showing the incidence of income status
|
Sl. No.
|
Income Status
|
No. of patients
|
Percentage
|
|
1
|
LIG
|
10
|
15.15
|
|
2
|
MIG
|
36
|
54.55
|
|
3
|
HIG
|
20
|
30.30
|
|
Total
|
66
|
100.00
|
EDUCATIONAL STATUS
When educational status was
enquired, patients of both literate and illiterate group were
found in this series. The educational status as found is given
in Table No. 6.
Table No. 6:
Showing the incidence of Educational Status
|
Sl. No.
|
Educational Status
|
No. of patients
|
Percentage
|
|
1
|
Illiterate
|
6
|
9.10
|
|
2
|
Literate
a) Primary
b) Madhyamik
c) Higher Secondary
d) Graduate
e) Post Graduate
|
60
|
90.90
|
|
9
|
15.00
|
|
11
|
18.33
|
|
9
|
15.00
|
|
18
|
30.00
|
|
13
|
21.67
|
RURAL URBAN INCIDENCE
This study included
patients from urban and rural areas and shown in Table No. 7
Table No. 7:
Showing the Rural and Urban Incidence
|
Sl. No.
|
Rural/ Urban
|
No. of patients
|
Percentage
|
|
1
|
Rural
|
27
|
40.90
|
|
2
|
Urban
|
39
|
59.10
|
|
Total
|
66
|
100.00
|
INCIDENCE OF DIET HABIT
Patients included in the
present study were found to have both types of diet habits
(vegetarian and non-vegetarian), which are presented in Table
No. 8.
Table No. 8:
Showing the incidence of diet habits.
|
Sl. No.
|
Diet Habits
|
No. of patients
|
Percentage
|
|
1
|
Non vegetarian
|
52
|
78.78
|
|
2
|
Vegetarian
|
14
|
21.20
|
|
Total
|
66
|
100.00
|
INCIDENCE OF NATURE OF
WORK
In this trial nature of
work were studied which are presented in Table No. 9.
Table No. 9:
Showing the incidence of nature of work
|
Sl. No.
|
Nature of work
|
No. of patients
|
Percentage
|
|
1
|
Sedentary
|
34
|
51.52
|
|
2
|
Moderate
|
28
|
42.42
|
|
3
|
Hardworker
|
4
|
6.06
|
|
Total
|
66
|
100.00
|
INCIDENCE OF MARITAL
STATUS
In this study married
unmarried, both patients are included which are presented in
Table No. 10
Table No. 10:
Showing the incidence of Marital Status
|
Sl. No.
|
Marital Status
|
No. of patients
|
Percentage
|
|
1
|
Unmarried
|
15
|
22.73
|
|
2
|
Married
|
51
|
77.27
|
|
Total
|
66
|
100.00
|
RESULT AND OBSERVATION
Trial Group:
Trial group consisted of 46
patients, among them 32 cases had completed the full tenure of
trial and 14 cases had not completed the full trial. All the
cases were given the “EZI SLIM” capsules in the dose of 2
capsules (500mg each capsule) twice daily before food for 90
days, with water.
Patients were observed in
terms of subjective improvements before treatment, during
treatment and after treatment. The response of treatment on
clinical features as observed before treatment and after
treatment in 32 cases in trial group are presented below in
Table No. 11
Table No. 11:
Showing the response of treatment on subjective features of
Obesity
|
Sl. No.
|
Chief complains
|
No. of patients
before treatment
|
No. of patients
relieved after treatment
|
Percentage of
relief
|
|
1
|
Excessive appetite
|
24
|
15
|
37.50
|
|
2
|
Excessive thirst
|
26
|
18
|
33.33
|
|
3
|
Excessive sleep
|
28
|
24
|
14.28
|
|
4
|
Excessive perspiration
|
21
|
18
|
14.28
|
|
5
|
Inability to work
|
8
|
6
|
25.00
|
|
6
|
Dysponea on exertion
|
30
|
24
|
20.00
|
|
7
|
Tiredness of the body
|
28
|
18
|
35.71
|
|
8
|
Foul small of the body
|
24
|
12
|
50.00
|
|
9
|
Malaise
|
26
|
18
|
23.07
|
|
10
|
Rapid increasing of
weight
|
27
|
4
|
85.18
|
|
11
|
Sexual power
decreased/ increased
|
25
|
20
|
20.00
|
|
12
|
Heaviness of body
|
26
|
22
|
15.38
|
|
13
|
Vertigo
|
24
|
18
|
25.00
|
From the above table it is
revealed that the percentage of relief of different clinical
features was not highly satisfactory. But it was interesting to
note the relief of rapid increasing of body weight (85.18%),
foul smell of the body (50%), excessive appetite (37.50%),
tiredness of the body (35.71%), excessive thirst (33.33%) after
the treatment. Relief of other clinical features were below 25%.
But there was a definite response on all of the clinical
features observed in the study.
Apart of the clinical
features we have also used certain markers which were taken for
assessment of the response of treatment. The response of
treatment on these markers as observed before treatment and
after treatment in the trial group cases are presented
statistically below in Table No. 12 – 15 .
Table No. 12:
Showing the response of treatment on body weight
|
Body weight
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
77.12
|
75.09
|
2.00
|
|
SD ±
|
3.49
|
3.45
|
0.85
|
|
SE ±
|
0.61
|
0.61
|
0.15
|
|
t
|
|
|
13.33
|
|
p
|
|
|
< 0.001
|
It is revealed from the
above table that the mean body weight was 77.12 kg before
treatment and that was reduced to 75.09 kg after treatment and
the p value is highly significant (p<0.001).
Table No.13:
Showing the response of treatment on Ponderal Index
|
Ponderal Index
|
Before treatment
|
After treatment
|
Increased value
|
|
Mean
|
10.17
|
10.45
|
0.27
|
|
SD ±
|
0.28
|
0.27
|
0.17
|
|
SE ±
|
0.04
|
0.04
|
0.03
|
|
t
|
|
|
9.22
|
|
p
|
|
|
< 0.001
|
From the above table it is
clear that mean Ponderal Index was 10.17 before treatment which
was found increased to 10.45 after treatment and the p value is
highly significant (p<0.001).
Table No.14:
Showing the response of treatment on Fat Fold Thickness (FFT)
|
FFT
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
5.50
|
5.20
|
0.30
|
|
SD ±
|
0.56
|
0.55
|
0.15
|
|
SE ±
|
0.09
|
0.09
|
0.03
|
|
t
|
|
|
10.10
|
|
p
|
|
|
< 0.001
|
From the above table it is
revealed that the mean Fat Fold Thickness (FFT) before treatment
was 5.50 cm which was reduced to 5.20 cm after treatment and the
decreased Fat Fold Thickness (FFT) is 0.30 cm. The p value is
highly significant (p<0.001).
Table No.15:
Showing the response of treatment on BOM (Body Mass Index)
|
BMI
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
35.05
|
34.50
|
0.54
|
|
SD ±
|
1.69
|
1.70
|
0.35
|
|
SE ±
|
0.29
|
0.30
|
0.06
|
|
t
|
|
|
9.11
|
|
p
|
|
|
< 0.001
|
From the above table it is
clear that the mean BMI was 35.05 kg/m2 before treatment which
decreased to 34.50 kg/m2 after treatment and the p value is
highly significant (p<0.001).
Effect of treatment on
objective criteria
In this study lipid profile
was the only objective criteria to assess the response of the
treatment. Cholesterol, HDL, LDL, VLDL and Triglyceride were
examined before starting the treatment and at the end of the
treatment also. The findings are statically analysed in the
following tables.
Table No. 16:
Showing the statistical analysis of response of treatment on
Cholesterol.
|
Cholesterol
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
212.93
|
181.84
|
31.09
|
|
SD ±
|
22.93
|
22.81
|
15.85
|
|
SE ±
|
4.05
|
4.03
|
2.80
|
|
t
|
|
|
11.10
|
|
p
|
|
|
< 0.001
|
From the above table it is
clear that the mean Cholesterol before treatment was 212.93
mg/dl which was reduced to 181.84 mg/dl after treatment and the
decreased Cholesterol is 31.09 mg/dl. The p value is highly
significant (p<0.001).
Table No. 17:
Showing the response of treatment on HDL
|
HDL
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
40.91
|
53.31
|
12.39
|
|
SD ±
|
9.23
|
9.66
|
7.96
|
|
SE ±
|
1.63
|
1.70
|
1.40
|
|
t
|
|
|
8.85
|
|
p
|
|
|
< 0.001
|
It is revealed from the
above table that the mean HDL level was 40.91 mg/dl before
treatment and that was increased to 53.31 mg/dl after treatment
and the p value is highly significant (p<0.001).
Table No. 18:
Showing the statistical analysis of response of treatment on LDL
|
LDL
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
126.65
|
119.50
|
7.15
|
|
SD ±
|
16.98
|
21.18
|
15.55
|
|
SE ±
|
3.00
|
3.74
|
2.74
|
|
t
|
|
|
2.61
|
|
p
|
|
|
< 0.01
|
In the above table the mean
LDL was 126.65 mg/dl before treatment which decreased to 119.50
mg/dl after treatment and the p value is moderately significant
(p<0.01).
Table No. 19:
Showing the statistical analysis of response of treatment on
VLDL.
|
VLDL
|
Before treatment
|
After treatment
|
Decreased value
|
|
Mean
|
39.5
|
35.15
|
4.34
|
|
SD ±
|
12.07
|
10.26
|
4.09
|
|
SE ±
|
2.13
|
1.81
|
0.72
|
|
t
|
|
|
6.03
|
|
p
|
|
|
< 0.001
|
Fig – 1 -
Showing the response of Treatment on Lipid profile
From the above table it is revealed that the VLDL before
treatment was 39.5 mg/dl which decreased to 35.15 mg/dl
after treatment and the p value is highly significant
(p<0.001).
Table No. 20:
Showing the statistical analysis of response of treatment on
Triglyceride.
|
Triglyceride
|
Before
treatment
|
After treatment
|
Decreased value
|
|
Mean
|
188.71
|
167.40
|
21.31
|
|
SD ±
|
53.06
|
40.00
|
20.22
|
|
SE ±
|
9.38
|
7.07
|
3.57
|
|
t
|
|
|
5.96
|
|
p
|
|
|
< 0.001
|
From the above table it
is clear that the mean Triglyceride was 188.71 mg/dl before
treatment which was reduced to 167.40 mg/dl after treatment
and the p value is highly significant (p<0.001).
CONTROL GROUP
Control Group consisted
of 20 patients, among them 10 cases had completed the full
tenure of trial and 10 cases had not completed the full
trial. All the cases were given the placebo capsules in the
dose of 2 capsules (500mg each cap) twice daily before food
for 90 days, with water.
Patients were observed
in terms of subjective improvements before treatment, during
treatment and after treatment. The response of treatment on
clinical features as observed before treatment, and after
treatment in 10 cases in control group are presented below
in Table no. 21.
Table No. 21:
Showing the response of treatment on subject features of
obesity in control group.
|
Sl.
No.
|
Chief complains
|
No. of patients
before treatment
|
No. of patients
relieved after treatment
|
Percentage of
relief
|
|
1.
|
Excessive appetite
|
7
|
8
|
-14.28
|
|
2.
|
Excessive thirst
|
6
|
8
|
- 33.33
|
|
3.
|
Excessive sleep
|
6
|
7
|
- 12.50
|
|
4.
|
Excessive
perspiration
|
6
|
7
|
- 16.66
|
|
5.
|
Inability to work
|
2
|
3
|
- 50.00
|
|
6.
|
Dysponea on
exertion
|
9
|
10
|
- 11.11
|
|
7.
|
Tiredness of the
body
|
8
|
9
|
- 12.50
|
|
8.
|
Foul small of the
body
|
8
|
9
|
- 12.50
|
|
9.
|
Malaise
|
7
|
10
|
- 42.85
|
|
10.
|
Rapid increasing
of weight
|
8
|
10
|
- 25.00
|
|
11.
|
Sexual power
decreased/ increased
|
6
|
7
|
- 16.60
|
|
12.
|
Heaviness of body
|
6
|
7
|
- 16.60
|
|
13.
|
Vertigo
|
7
|
9
|
- 28.57
|
From the above table it
is clear that there was not any improvement in clinical
features on control group of patients and the clinical
features had deteriorated.
Along with the clinical
features we have also followed certain markers which had
taken for assessment of the response of treatment. The
response of treatment on these markers as observed before
treatment and after treatment in the Control Group cases are
presented statistically below in Table No. 22 – 25.
Table No. 22:
Showing the response of treatment of body weight
|
Body weight
|
Before
treatment
|
After treatment
|
Increased value
|
|
Mean
|
75.15
|
76.35
|
- 1.20
|
|
SD ±
|
5.03
|
4.70
|
0.75
|
|
SE ±
|
1.58
|
1.48
|
0.23
|
|
t
|
|
|
- 5.21
|
|
p
|
|
|
Insignificant
|
It is revealed from the
above table that the mean body weight was 75.15 kg before
treatment and that was increased to 76.35 kg after treatment
and the p value is insignificant.
Table No. 23:
Showing the response of treatment on Ponderal Index.
|
Ponderal Index
|
Before
treatment
|
After treatment
|
Decreased value
|
|
Mean
|
10.07
|
9.82
|
0.24
|
|
SD ±
|
0.47
|
0.56
|
0.14
|
|
SE ±
|
0.14
|
0.17
|
0.04
|
|
t
|
|
|
6.22
|
|
p
|
|
|
Insignificant
|
From the above table it
is clear that mean Ponderal Index was 10.07 before treatment
which was found decreased to 9.82 after treatment and the p
value is insignificant.
Table No. 24:
Showing the response of treatment on Fat Fold Thickness (FFT)
|
FFT
|
Before
treatment
|
After treatment
|
Increased value
|
|
Mean
|
5.51
|
5.63
|
-0.12
|
|
SD ±
|
0.44
|
0.44
|
0.06
|
|
SE ±
|
0.14
|
0.13
|
0.02
|
|
t
|
|
|
-6
|
|
p
|
|
|
Insignificant
|
From the above table it
is revealed that the mean Fat Fold Thickness (FFT) before
treatment was 5.51 cm which increased to 5.63 cm after
treatment and the p value is insignificant.
Table No. 25:
Showing the response of treatment on BMI (Body Mass Index)
|
BMI
|
Before
treatment
|
After treatment
|
Increased value
|
|
Mean
|
35.51
|
36.04
|
-0.52
|
|
SD ±
|
1.41
|
1.29
|
0.40
|
|
SE ±
|
0.44
|
0.41
|
0.12
|
|
t
|
|
|
-4.40
|
|
p
|
|
|
Insignificant
|
From the above table it
is clear that the mean BMI was 35.51 kg/ m2 before treatment
which increased to 36.04 kg/m2 after treatment and the p
value is insignificant.
Effect of treatment
on objective criteria
In this control group
study lipid profile was the only objective criteria to asses
the response of the treatment. Cholesterol, HDL, LDL, VLDL
and Triglyceride were examined before starting the treatment
and at the end of the treatment also. The findings are
statically analysed in the following tables.
Table No. 26:
Showing the statistical analysis of response of treatment on
Cholesterol.
|
Cholesterol
|
Before
treatment
|
After treatment
|
Increased value
|
|
Mean
|
207.8
|
220
|
-12.30
|
|
SD ±
|
11.39
|
12.35
|
3.62
|
|
SE ±
|
3.60
|
3.90
|
1.14
|
|
t
|
|
|
-10.78
|
|
p
|
|
|
Insignificant
|
From the above table it
is clear that the mean Chilesterol before treatment was
207.8 mg/dl which was increased to 220mg/dl after treatment
and the p value is insignificant.
Table No. 27:
Showing the response of treatment on HDL
|
HDL
|
Before
treatment
|
After treatment
|
Decreased value
|
|
Mean
|
44.70
|
38.70
|
6.00
|
|
SD ±
|
4.85
|
5.35
|
2.00
|
|
SE ±
|
1.53
|
1.69
|
0.63
|
|
t
|
|
|
9.52
|
|
p
|
|
|
Insignificant
|
It is revealed from the
above table that the mean HDL level was 44.70 mg/dl before
treatment and that was decreased to 38.70 mg/dl after
treatment and the p value is insignificant.
Table No. 28:
Showing the statistical analysis of response of treatment on
LDL
|
HDL
|
Before
treatment
|
After treatment
|
Decreased value
|
|
Mean
|
44.70
|
38.70
|
6.00
|
|
SD ±
|
4.85
|
5.35
|
2.00
|
|
SE ±
|
1.53
|
1.69
|
0.63
|
|
t
|
|
|
9.52
|
|
p
|
|
|
Insignificant
|
In the above table the
mean LDL was 126.30 mg/dl before treatment which increased
to 134.80 mg/dl after treatment and the p value is
insignificant.
Table No. 29:
Showing the statistical analysis of response of VLDL
|
VLDL
|
Before
treatment
|
After treatment
|
Increased value
|
|
Mean
|
45.90
|
54.60
|
-8.70
|
|
SD ±
|
6.45
|
10.51
|
6.07
|
|
SE ±
|
2.04
|
3.32
|
1.92
|
|
t
|
|
|
-4.53
|
|
p
|
|
|
Insignificant
|
From the above table it
is revealed that the mean VLDL before treatment was 45.90
mg/dl which increased to 54.60 mg/dl after treatment and the
p value is insignificant.
Table No. 30:
Showing the statistical analysis of response of treatment on
Triglyceride
|
Triglyceride
|
Before
treatment
|
After treatment
|
Increased value
|
|
Mean
|
173.10
|
188.00
|
-14.90
|
|
SD ±
|
12.73
|
13.08
|
9.60
|
|
SE ±
|
4.02
|
4.13
|
3.03
|
|
t
|
|
|
-4.91
|
|
p
|
|
|
Insignificant
|
From the above table it
is clear that the mean Triglyceride was 173.10 mg/dl before
treatment which was increased to 188.00 mg/dl after
treatment and the p value is insignificant.
Discussion:
The present trial
included 66 patients suffering from obesity. The total cases
were randomly divided into two groups, viz. trial group and
control group. Trial group consisted of 46 patients to whom
“EZI SLIM” capsule was given in the dose of 2 capsules
twice a day for a period of 90 days. Out of 46 cases of
trial group 32 cases could be follow up properly during the
treatment schedule (i.e 90 days) and the rest of the cases
had dropped out at different point of time. Control group
included 20 patients to whom placebo capsule was given in
the dose of two capsules twice a day for a period of 90
days. Out of the total cases in the control group 10 cases
could be follow up for 90 days, the total tenure of the
treatment and the rest of cases had discontinued at
different times.
The effect of the
treatment on both these group of patients were evaluated
during the treatment and the response was assessed at the
end of the treatment. The response of the treatment was
observed on subjective improvement and objective
improvements. At the end of the treatment, the result was
assessed in term of excellent response, good response and
poor response. The patients were included under excellent
response group when they showed more than 70% relief of
subjective features with reduction of body weight more than
3 kg. Cholesterol more than 50 mg/dl, LDL more than 20
mg/dl, VLDL more than 10 mg/dl and Triglyceride more than 30
mg/dl. The patients were included under good response group
when they showed relief of subjective features between 51 to
70% with reduction of Body weight between 2 – 3 kg,
Cholesterol between 31
– 50 mg/dl, LDL between 11 – 20 mg/dl, VLDL between 6
– 10 mg/dl and Triglyceride between 21 – 30 mg/dl. The
patients showing relief of subjective features below 51%
with reduction of Body weight below 2 kg, Cholesterol less
than 30 mg/dl, LDL less than 10 mg/dl, VLDL less than 5
mg/dl and Triglyceride less than 20 mg/dl were included
under poor response group. In consideration to the total
effect of the drug in trial group 6.25% cases were included
under excellent response group, 25% under good response
group and 68.75% under poor response group.
Fig – 2 – The
total response of the Treatment
In this clinical study
interestingly we have noted that almost all the cases had
responded to the treatment in various degrees which were
observed by subjective and objective criterias. Though this
medicine has not reduced body weight to a marked level but
it was found to reduce the weight in all cases and none of
the cases had complained increasement of the body weight in
trial group. The clinical features were also found to be
reduced. Moreover the product “EZI SLIM” capsules has
shown its hypolipidemic effect by lowering the lipid levels
like Cholesterol, LDL, VLDL and Triglyceride on one hand and
on the other hand by increasing HDL level.
Any improvement in
patients of control group was not found when the effect of
the treatment on subjective criterias and objective
criterias were analysed. The response in all the objective
criterias was insignificant.
When the response of
the treatment in both the groups were analysed and compared
it was revealed that there is definite improvement in the
patients of obesity treated with “EZI SLIM” capsules.
During the clinical
study of the “EZI SLIM” capsules any clinical toxicity
or side effect was not noticed.
Conclusion
The product “EZI
SLIM” capsule was found to be an effective product on
obesity and the result was encouraging for further study for
its hypolipidemic effect. “EZI SLIM” capsule has shown
encouraging result after 6 week of treatment particularly on
the subjective criterias. After 90 days of treatment along
with the improvement of subjective criterias significant
response was also noticed on objective criterias, i.e. lipid
profiles without any side effect. Hence, “EZI SLIM”
capsule can be safely prescribed in Obesity and
Hyperlipidemia for a long time.
Further study of “EZI
SLIM” capsules in patients of obesity and hyperlipidemia/dislipidemia
for a longer duration is recommended.
|
