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

Study Overview
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Brief Summary
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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.

Official Title
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Antioxidant for Improvement of Hepatic Function in Patients With Alcohol Liver Disease Without Cirrhosis: Non-randomized Interventional Cohort Study

Conditions
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Alcoholic Liver Disease

Intervention / Treatment
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* Drug: Livitol-70


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in radiological response | The degree of fatty infiltration will be assessed by ultrasound. | 3 months | 
| Change in maddrey discriminant function(DF) |  | 3 months |