A clinical trial to study the effects of RTFIT Tablets (Racemethionine 200 mg + Taurine 500 mg Tablets) in patients with alcoholic liver disease.

Phase 3

Not yet recruiting

Conditions: Alcoholic liver disease

Registration Number: CTRI/2011/05/001764

Lead Sponsor: Zota Healthcare Ltd

Brief Summary: The Study is Randomized, Open Label, Parallel Group, Placebo-controlled, Efficacy and Safety Study of RTFITTablets in200 patients with alcoholic liver disease that will be conducted in india.

**Primary Outcome Measures: xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /**

The efficacy will be evaluated by Liver Function Test (LFT)

**Secondary Outcome Measures:**

Estimation of safety of RTFIT Tablets inpatients with alcoholic liver disease based on Adverse Events

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 200

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Outcome Measures:	at baseline, 7th day, 14th day, 21st day, 28th day, and 35th day.
The efficacy will be evaluated by Liver Function Test (LFT)	at baseline, 7th day, 14th day, 21st day, 28th day, and 35th day.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome Measures:	Estimation of safety of RTFIT Tablets in patients with alcoholic liver disease based on Adverse Events

Trial Locations

Locations (1): Navjeevan Hospital
🇮🇳
Thane, MAHARASHTRA, India
Navjeevan Hospital
🇮🇳Thane, MAHARASHTRA, India
Dr Milind Joshi
Principal investigator
mandarjoshi_83@yahoo.co.in