Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease

• Status: Not yet recruiting
• Trial end date: 2028-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Alcoholic liver disease represents the major health issues and it ranges from simple steatosis to cirrhosis. There is a paucity of data to support the allopathic intervention among these group of patients. Livitol-17 consist of the 3 whole herbs and extract which has antioxidant, hepatoprotective as well as reno-protective properties. The aim of this trial is to study the efficacy of herbal supplement to improve the liver function of alcoholic liver disease subject.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Composite Interceptive Med Science; Organic India

Criteria

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:

• Chronic alcohol intake, Identified with AUDIT(Alcohol Use Disorder Inventory Test) Questionnaire

• Active alcohol use until 4 weeks prior to presentation

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

• Over 1.5 ratio of AST to ALT

• Maddrey Discriminant function(DF) less than 30

Exclusion Criteria:

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

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

• Hepatic disorders due to cardiac causes, inherited metabolic causes, hemochromatosis and Wilson's disease

• Participants with active viral hepatitis

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

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

• Pregnant, attempting to conceive, or lactating women

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