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Clinically Tested Products


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 –

  1. 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.

  1. To evaluate the effect of capsule “EZI SLIM” on lipid levels of the body to be assessed by bio chemical study.

  1. 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.

  1. Body weight more than 20% above the ideal body weight.

  2. Ponderal Index less than 12.

  3. A fat fold thickness (FFT) greater than 2.5 cm at the tip of scapula in males and mid triceps regions in females.

  4. Grading of obesity based on Body Mass Index (BMI).

B)    Objective Criterias

The following laboratory investigations were carried out for diagnosis and differential diagnosis.

  1. Lipid profile

  2. Blood sugar (F & PP)

  3. Routine Hematological Test

  4. Thyroid profile

  5. 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.

  1. 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.

  2. 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.