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Clinical Trial Report of LIVGOOD In Liver Disorder 

INTRODUCTION :

The LIVER is the largest gland of the body. It is situated in the right hypochondrium. It plays a central and varied role in many essential physiological process. The liver is essential for life and it is the chemical factory of the body. It may viewed as serving a regulatory and protective functions for whole organism. To the extent of that such biotransformation results in the formation of toxic product as in the case of certain drugs, the liver may be bear attack as their adverse effects. LIVER  helps in all shorts of metabolism, blood formation, bile secretion, vitamins synthesis, heat regulation and many other performances are generally done in all the times. So the careful assessment is equally important in the patients with obvious liver diseases. In this study the "LIVGOOD" capsule was trailed in the patients of liver disorders to know the efficiency of the drug clinically.

AIM AND OBJECT :

To evaluate the therapeutic value of "Livgood" Capsules in the patients of liver disorders, the present clinical trial was under taken. Total 55 cases have been registered for this study. But out of these cases only 50 cases were included in the drug trial, who had followed the full treatment schedule.

MATERIAL AND METHOD :

Total 55 patients of liver disorders were registered during the course of trial. The study consists clinical patterns in the management of the particulars condition with the "LIVGOOD" capsules. out of 55 cases had followed full term (90 days) treatment schedule. The rest of the cases had discontinued the course of treatment.

This study consisted of clinical pattern, the liver disorders and the management of the particular condition with "Livgood" capsules.
 
The clinical pattern were studied in all the 55 cases for incidence of age, sex, religion, occupation, economic status, education and social status and symptoms of liver disorders following the incidence of L.F.T.

SELECTION OF CASES :

All the patients selected for the study were interrogated and details history recorded in the case record form. All the patients were thoroughly examined and findings were recorded. After the clinical examination patients were subjected for laboratory investigation, routine examination of blood, stool and urine were done and to establish the final diagnosis, liver function test (L.F.T.) were done. The individual who have symptoms of liver disorders with or without raised Bilirubin level, S.G.P.T, S.G.O.T. and Alkaline phosphatase etc. were subjected to clinical trial.

METHODS OF DRUG ADMINISTRATION :
 
The drug "Livgood" was administered in the form of capsules prepared and supplied by "GOOD CARE PHARMA PVT. LTD., 1, Gupta Lane, kolkata - 700006. The patients liver disorder taken for the study, were administered 2 capsule (500 MG Each) twice daily orally morning and evening with water for a period of 90 days.

DIET :

All the patients selected for the trial were advised to avoid butter, ghee and spicy food.

FOLLOW UP :
 
Follow up study was conducted in all cases at interval of one month for 3 months (90 days), L.F.T. was done in each cases in every month.

CLINICAL PATTERN :

The present study consists of total 50 cases who have symptoms of liver disorders and completed the full course
of treatment schedule (i.e., 90 days). But we had registered 55 cases for the present study, out of which 5 cases had not completed the full course of treatment. So the clinical pattern will be discussed on 55 cases. But the result will be analyzed on observation of the findings of 50 cases.

Age Incidents :

Patient of the present study were from 20 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

21-35

25

45.45

2

36-50

24

43.64

3

51& Above

06

10.91

Total

55

100.00

Sex Incidnts :

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

35

63.63

2

Female

20

36.37

Total

55

100.00

Religion Incidents :
 
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

54.54

2

Hindu

20

36.36

3

Christian

05

10.91

Total

55

100.00

Occupation Incidents :

In this study patients belonging to various occupations were included and shown in Table No. 4.

Table No. 4 showing the incidence of Occupation

Sl. No.

Religion

No. of Patients

Percentage

1

Service

13

23.64

2

House-Wives

12

21.82

3

Labour

10

18.18

4

Cultivator

05

9.09

5

Student

05

9.09

6

Businessman

08

14.54

7

Retired

02

3.64

Total

55

100.00

Economic Status :

In this study patients of different income groups were recorded and shown in Table No. 5.

Table No. 5: Showing the incidence of Income Status

SI. No.

Income Status

No. of Patients

Percentage

1 .

L.I.G.

37

67.27

2.

M.I.G.

18

32.73

Total

44

100.00

Educational Status :
 
When educational status was enquired, patients of both literate and illiterate were found in this series. The educational status as found are given in Table No. 6

Table No. 6 showing the incidence of Educational Status

Sl. No.

Religion

No. of Patients

Percentage

1

Illiterate

10

18.18

2

Primary

20

36.37

3

Madhyamik

10

18.18

4

Higher Secendary

04

7.27

5

Graduate

09

16.36

6

Post Graduate

02

3.64

Total

55

100.00

Rural and urban Incidents :
 
This study included patients from urban and rural areas shown in Table no. 7.

Table No. 7: Showing the Incidence of Rural and Urban

SI. No.

Rural / Urban

No. of Patients

Percentage

1.

Rural

20

36.36

2.

Urban

35

63.64

Total

55

100.00

Incidence of Diet Habits :

Patients included in the present study were found to have both types of diet habits (Vegetarian & Non-Vegetarian), which are presented in Table No. 8.

Table No. 8 showing the incidence of Diet Habits

SI. No.

Diet Habits

No. of Patichts

Percentage

1.

Non Vegetarian

37

67.27

2.

Vegetarian

18

32.73

Total

55

100.00


Incidence of Nature of Work :

In this trial study 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

Secondary

26

47.27

2

Moderate

17

30.91

3

Hard worker

12

21.82

Total

55

100.00

RESULT AND OBSERVATION :
 
The results of 50 patients who had completed the treatment schedule (i.e., 90 days) were observed in terms of subjective improvements, which are presented bellow in Table No. 10.

Table No.10 showing the response of treatment on subjective features of sexual disorder

Sl. No.

Symptoms

No. of Pt. before treatment

No. of Pt. after treatment

Percentage of relief

1

Anorexia

50

42

84.00

2

Yellow Urine

30

25

83.33

3

Yellow eyes / Palms

20

18

90.00

4

Upper Abdominal Discomfort

46

36

78.27

5

Fever

34

28

82.36

6

Nausea

32

25

78.12

7

Vomiting

20

16

82.36

8

Loss of Weight

42

21

50.00

9

Headache

35

26

74.29

10

Skin Rashes

11

09

81.82

11

Bleeding Nose

08

06

75.00

12

Weakness

44

30

68.18

13

Loss Libido

30

30

00.00

In all patients who had complete the treatment schedule of 90 (Ninety) days were also observed in terms of objective improvements which are presented in Table No. 11.

Table No.11 showing the response of treatment on objective features of Liver Disorders (Mean effects, n=50)

Sl. No.

 

B.T

A.T

1

Serum Bilirubin Mg / d1

2.82 + 0.40
-

0.90 + 0.04
-

2

Alkaline Phosphatase

271.09 + 10.05
 -

214.92 + 7.80
   -

3

SGOT

104.20 + 36.97
 -

34.36 + 1.70
  -

4

SGPT

108.47 + 38.32
 -

35.66 + 1.37
  -


DISCUSSION:
 
55 patients suffering from liver disorders were included in the present series of clinical study. The clinical study was under taken to evaluate the efficacy, the drug "Livgood" capsule were given in these cases. Out of 55 cases 50 cases could be followed up properly.
 
To all the patients in the trial "Livgood" capsules was given in the dose of 2 cap (500 mg each) twice orally, morning and evening with water for a period of 90 days. The effects of the drug on 50 patients was observed in consideration of subjective and objective improvements. At the end of treatment the result was assessed in terms of excellent response, good response and poor response. The patient were included in the excellent response group, when the objective criteria's become normal and showed 75% relief from classical clinical features within 3 months.
 
The patients were included under the good response group, when they showed more than 50% relief of subjective features and normal objective parameters. The patients were included in poor response group when they showed less than 50% relief of subjective criteria's and negligible improvements of objective criteria's.
 
When the total effects of the drug on the subjective criteria's and subjective criteria's were taken into consideration, 28% cases were included in excellent response group, 58% cases in good response group and 14.00% in poor response group to the treatment in the "Livgood" capsule.


During study of the "Livgood" capsules none of the patients had shown any side effects.

CONCLUSION:

The drug "Livgood" capsules had been found to be a hepatoprotective drug with definite effects in the treatment of liver disorders. The results in the trial group has shown encouraging result after 30 days of treatment. After 90 days of the treatment the statistical data has shown the significant response in the objective criterias like Serum Bilirubin, SGOT, SGPT and Alkaline Phosphatase. So "Livgood" can safely be given in liver disorders.

ACKNOWLEDGEMENT:
 
We sincerely acknowledge Dr. P.K.Mukherjee, Project officer and Asst. Director (Ayurveda) for sanctioning permission to conduct the trial at IPGAE & Research at Shyamadas Vaidyasastrapith Hospital, Kolkata - 700006. We further acknowledge M/s Goodcare Pharma Ltd., 1, Gupta Lane, Kolkata - 700006, for their financial support for this trial.

Research Scholar
Dr. Mofizuddin Ahmed
Co-investigator
Dr. P.C. Tripathi



Principal Investigator
Dr. B. P. Shaw

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