Health Condition 1: null- Alcoholic liver disease
Conditions
Interventions
Intervention1: Fixed dose combination of Racemethionine and Taurine Tablets or placebo: Patients will be administered either Fixed dose combination of Racemethionine 200 mg and Taurine 500 mg Tablets
Sponsors
Zota Healthcare Ltd
Eligibility
Inclusion criteria
Inclusion criteria: i. Patients of either sex between 20-60 years of age. ii. Patients having history of alcoholic hepatitis, non alcoholic seatohepatitis (NASH), viral hepatitis (Jaundice), sclerosis of liver and drug induced hepatitis.
Exclusion criteria
Exclusion criteria: i. Pregnancy or lactation ii. Fasting glucose levels greater than 250 mg per deciliter iii. Contraindication to liver biopsy iv. Concomitant disease with reduced life expectancy v. Hepatic failure vi. Severe psychiatric conditions vii. Drug dependence viii. History of hemochromatosis, Wilson Disease, cholangitis, other chronic disease, renal insufficiency ix. A known hypersensitivity to Taurine and Methionine or its structurally related compounds
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Outcome Measures: The efficacy will be evaluated by Liver Function Test (LFT) Timepoint: at baseline, 7th day, 14th day, 21st day, 28th day, and 35th day. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Outcome Measures: Estimation of safety of RTFIT Tablets in patients with alcoholic liver disease based on Adverse Events Timepoint: baseline, 7th day, 14th day, 21st day, 28th day, and 35th day. | — |
Countries
India
Contacts
Public ContactDrHarishkumar Lalan
Outcome results
None listed