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

Primary Purpose

Alcoholic Liver Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Livitol-70
Sponsored by
Composite Interceptive Med Science
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alcoholic Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Mazumdar Shaw Medical Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

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).

Outcomes

Primary Outcome Measures

Change from baseline in AST(Aspartate Aminotransferase)
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in ALT(Alanine Aminotransferase)
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in ALP(Alkaline Phosphatase)
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in GGT(Gamma Glutamyl Transferase)
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Change from baseline in serum total bilirubin
The above mentioned test will be measured with panel of Liver function test at central laboratory.
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.

Secondary Outcome Measures

Change in radiological response
The degree of fatty infiltration will be assessed by ultrasound.
Change in maddrey discriminant function(DF)

Full Information

First Posted
April 11, 2018
Last Updated
April 19, 2018
Sponsor
Composite Interceptive Med Science
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1. Study Identification

Unique Protocol Identification Number
NCT03503708
Brief Title
Herbal Supplements for Improvement of Liver Function in Participants With Alcoholic Liver Disease
Official Title
Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2018 (Anticipated)
Primary Completion Date
October 30, 2018 (Anticipated)
Study Completion Date
November 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Composite Interceptive Med Science

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholic Liver Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Livitol-70
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in AST(Aspartate Aminotransferase)
Description
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Time Frame
3 months
Title
Change from baseline in ALT(Alanine Aminotransferase)
Description
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Time Frame
3 months
Title
Change from baseline in ALP(Alkaline Phosphatase)
Description
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Time Frame
3 months
Title
Change from baseline in GGT(Gamma Glutamyl Transferase)
Description
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Time Frame
3 months
Title
Change from baseline in serum total bilirubin
Description
The above mentioned test will be measured with panel of Liver function test at central laboratory.
Time Frame
3 months
Title
Number of Subject with adverse events
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in radiological response
Description
The degree of fatty infiltration will be assessed by ultrasound.
Time Frame
3 months
Title
Change in maddrey discriminant function(DF)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alben Sigamani, MD
Phone
8884431444
Email
alben.sigamani.dr@narayanahealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sanjaya Chauhan, PharmD
Phone
9611252350
Email
drsanjayachauhan49@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alben Sigamani, MD
Organizational Affiliation
Narayana Hrudayalaya Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sanjaya Chauhan, PharmD
Organizational Affiliation
Composite Interceptive Med Science
Official's Role
Study Chair
Facility Information:
Facility Name
Mazumdar Shaw Medical Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560099
Country
India
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alben Sigamani, MD
Phone
8884431444
Email
alben.sigamani.dr@narayanahealth.org
First Name & Middle Initial & Last Name & Degree
Sanjaya Chauhan, PharmD
Phone
9611252350
Ext
Chauhan
Email
drsanjayachauhan49@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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