Herbal supplement to improve liver health in alcoholic perso

Not Applicable

• Conditions: Health Condition 1: null- Alcoholic Liver Disease

• Registration Number: CTRI/2018/05/013865
• Lead Sponsor: Composite Interceptive MedScience Laboratories Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Adults aged over 18 years with the evidence of alcoholic liver disease (ALD) based on a thorough history, physical examination, and laboratory tests and all of the following:

1. Chronic alcohol intake, Identified with AUDIT Questionnaire (A total sum of AUDIT >= 8 for men up to age 60, or >=4 for women, and men over age 60 is considered a positive screening test.)

2. Active alcohol use until 4 weeks prior to presentation

3. ALT and AST elevated >1.5 times the upper limit of normal

4. Over 1.5 ratio of AST to ALT

5. Maddrey Discriminant function(DF) less than 30

Exclusion Criteria

Any one of the following

1.Severe alcoholic hepatitis with cirrhosis or life expectancy less than 3 months

2. Severe renal impairment (Glomerular filtration rate below 60 ml/min per 1.73m2)

3. Hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and Wilsons disease

4. Participants with active viral hepatitis

5. Under going active treatment for alcohol withdrawal syndrome(AWS) at the study entry

6. Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc.

7. Pregnant, attempting to conceive, or lactating women

8. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.

Study & Design

• Study Type: Interventional
• Study Design: Not specified