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Search / Trial NCT03503708

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

Launched by COMPOSITE INTERCEPTIVE MED SCIENCE · Apr 19, 2018

Trial Information

Current as of May 04, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a herbal supplement called Livitol-17 on improving liver function in people with alcoholic liver disease (ALD). Alcoholic liver disease is a serious condition that can range from mild liver fat buildup to severe liver damage. The supplement is made from three different herbs that are believed to help protect the liver and improve its health. The goal of the trial is to see if taking this herbal supplement can help improve liver function in individuals who have been drinking alcohol.

To participate in this trial, you need to be an adult over 18 years old and have a diagnosis of alcoholic liver disease, which will be confirmed through medical history, physical exams, and lab tests. You should have a history of drinking alcohol and elevated liver enzymes in your blood tests. However, some individuals will not be eligible, such as those with severe liver damage, serious kidney issues, or certain other liver conditions. If you qualify and choose to participate, you can expect to be part of a study that aims to find new ways to support liver health in people affected by alcohol use. It's important to know that the trial is not yet recruiting participants, so you will need to wait for it to start.

Gender

ALL

Eligibility 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.

About Composite Interceptive Med Science

Composite Interceptive Med Science is a forward-thinking clinical trial sponsor dedicated to advancing innovative healthcare solutions through rigorous research and development. Specializing in interceptive therapies, the organization focuses on identifying and addressing early-stage medical conditions to improve patient outcomes. With a commitment to scientific excellence and collaboration, Composite Interceptive Med Science partners with leading healthcare institutions and professionals to conduct high-quality clinical trials that contribute to the evolving landscape of medical science. Their mission is to transform early intervention strategies into effective treatments that enhance the quality of life for patients worldwide.

Locations

Bangalore, Karnataka, India

Patients applied

0 patients applied

Trial Officials

Alben Sigamani, MD

Principal Investigator

Narayana Hrudayalaya Hospital

Sanjaya Chauhan, PharmD

Study Chair

Composite Interceptive Med Science

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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