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

• 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.

Primary outcomes

• 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.

Secondary outcomes

• Change in radiological response [3 months]: The degree of fatty infiltration will be assessed by ultrasound.
• Change in maddrey discriminant function(DF) [3 months]

Sex: All, ages: 18 Years to any

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.

• Alben Sigamani, MD, Principal investigator, Narayana Hrudayalaya Hospital
• Sanjaya Chauhan, PharmD, Study chair, Composite Interceptive Med Science