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

NCT03503708 | Not Yet Recruiting DMC

• 1 other identifier: OI-009-2018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcoholic Liver Disease

Outcome Measures

Primary Outcomes (6)

• Change from baseline in AST(Aspartate Aminotransferase)

  The above mentioned test will be measured with panel of Liver function test at central laboratory.

  3 months

• Change from baseline in ALT(Alanine Aminotransferase)

  The above mentioned test will be measured with panel of Liver function test at central laboratory.

  3 months

• Change from baseline in ALP(Alkaline Phosphatase)

  The above mentioned test will be measured with panel of Liver function test at central laboratory.

  3 months

• Change from baseline in GGT(Gamma Glutamyl Transferase)

  The above mentioned test will be measured with panel of Liver function test at central laboratory.

  3 months

• Change from baseline in serum total bilirubin

  The above mentioned test will be measured with panel of Liver function test at central laboratory.

  3 months

• Number of Subject with adverse events

  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.

  3 months

Secondary Outcomes (2)

• Change in radiological response

  3 months

• Change in maddrey discriminant function(DF)

  3 months

Study Arms (1)

Intervention Group

EXPERIMENTAL

All the eligible participants will receive Livitol-17 capsules. It consist of 390 mg of whole herbs and extract of Phyllanthus niruri (Bhumyamalaki), Boerhaavia diffusa (Punarnava) and Picroorrhiza kurroa (Katuki).

Drug: Livitol-70

Interventions

Livitol-70 DRUG

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Composite Interceptive Med Science: lead

Study Sites (1)

Mazumdar Shaw Medical Centre

Bangalore, Karnataka, 560099, India

Location

MeSH Terms

Conditions

Liver Diseases, Alcoholic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Alben Sigamani, MD

  Narayana Hrudayalaya Hospital

  PRINCIPAL INVESTIGATOR

• Sanjaya Chauhan, PharmD

  Composite Interceptive Med Science

  STUDY CHAIR

Central Study Contacts

Alben Sigamani, MD

CONTACT

8884431444; alben.sigamani.dr@narayanahealth.org

Sanjaya Chauhan, PharmD

CONTACT

9611252350; drsanjayachauhan49@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 20, 2018
• Study Start: May 30, 2018
• Primary Completion: October 30, 2018
• Study Completion (Estimated): November 30, 2028
• Last Updated: April 20, 2018

Record last verified: 2018-04

Locations

IN (1)