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

NCT03503708 · tracked via the Priya Life Science India tracker

Sponsor

Composite Interceptive Med Science

Phase

Not applicable

Started

2018-05-30

Last updated

2018-04-20

Condition(s) studied

Alcoholic Liver Disease

Investigational drug(s) / intervention(s)

Livitol-70

Livitol-70: Livitol-17 detoxifies, purifies and rejuvenates liver, kidney and spleen. Participants will be given the intervention in two bottles at each visit. Participant will be instructed to take two capsule twice daily at a fixed time in the day.

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change from baseline in AST(Aspartate Aminotransferase) — 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in ALT(Alanine Aminotransferase) — 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in ALP(Alkaline Phosphatase) — 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in GGT(Gamma Glutamyl Transferase) — 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in serum total bilirubin — 3 months
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Number of Subject with adverse events — 3 months
Adverse events is defined as any untoward medical occurrence that may not necessarily have a causal relationship with the treatment, but resulted in a dose reduction or discontinuation of treatment.

Trial sites (1)

Facility	City	Region	Status
Mazumdar Shaw Medical Centre	Bangalore	Karnataka

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03503708 on ClinicalTrials.gov ↗ ← All trials in India