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

• Sponsor: Composite Interceptive Med Science (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT03503708
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 126.1
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alcoholic Liver Disease	Drug: Livitol-70	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study
• Anticipated Study Start Date: May 30, 2018
• Anticipated Primary Completion Date: Oct 30, 2018
• Anticipated Study Completion Date: Nov 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Group 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; 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Secondary Outcome Measures

1. Change in radiological response [3 months]

   The degree of fatty infiltration will be assessed by ultrasound.

2. Change in maddrey discriminant function(DF) [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mazumdar Shaw Medical Centre	Bangalore	Karnataka	India	560099

Sponsors and Collaborators

• Composite Interceptive Med Science

Investigators

• Principal Investigator: Alben Sigamani, MD, Narayana Hrudayalaya Hospital
• Study Chair: Sanjaya Chauhan, PharmD, Composite Interceptive Med Science

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Composite Interceptive Med Science
• ClinicalTrials.gov Identifier: NCT03503708
• Other Study ID Numbers: OI-009-2018
• First Posted: Apr 20, 2018
• Last Update Posted: Apr 20, 2018
• Last Verified: Apr 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Liver Diseases, Alcoholic

Study Results

No Results Posted as of Apr 20, 2018