Efficacy of a polyherbal formulation and life style modification in the management of Non Alcoholic Fatty Liver Disease

Phase 3

• Conditions: Health Condition 1: K760- Fatty (change of) liver, not elsewhere classified

• Registration Number: CTRI/2024/08/071986
• Lead Sponsor: Government of West Bengal

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Pain in the upper and epigastric region/pain in the right upper quadrant, fullness of abdomen, feeling of nausea and vomiting, loss of appetite, constipation etc.

2.Elevated liver enzymes i.e. SGPT more than 1.5 times the normal value.

3.USG evidence of hepatomegaly with fatty changes in liver.

4. NAFLD Fibrosis score (NFS) range (less than -1.455 to 0.676).

5.Diagnosed NAFLD and referred from other outpatient departments

6. Patients who agreed to follow the study protocol and give constant for clinical trial.

Exclusion Criteria

1.Patient below 18 years and above 65 years.

2.Patient who are not willing to come under trial or give consent.

3.NAFLD Fibrosis score (NFS) range (more or equal to 0.676).

4. Alcoholic steatohepatitis

5. Alcoholic fatty liver (typically, a threshold of more than 20g/day for woman and more than 30g/day for men), ALT more or equal to 120 IU/L, total parental nutrition

6. Liver cirrhosis/fibrosis, heart or renal failure.

7. Underwent liver transplantation, gastrointestinal surgery.

8.Vascular diseases of the liver, allergy, liver mass.

9. H/o or presence of Type 1 DM

10.Presence of any other form of chronic liver disease

11.Hepatitis (A, B, C, D, E) positive patients

12.Wilsons disease or metabolic liver disease

13.Polycystic liver disease

14.Cystic fibrosis of liver

15.Non Alcoholic cirrhosis

16.Auto immune hepatitis

17.Primary and secondary Hepatic cellular Carcinoma (HCC)

18.STD’s

19.Gilbert disease

20.alpha 1 antitrypsin deficiency

21.Pregnant and lactating mother

22.History of heart attack or stroke

23.Mentally disabled patients

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
TO REDUCE THE SGPT LEVELS WITHIN THE NORMAL RANGETimepoint: 90 days

Secondary Outcome Measures

Name	Time	Method
AFLD FIBROSIS SCORE(NFS) less than -1.455Timepoint: 90 days