CLEARLIV Tablet in Alcoholic Liver Disease Patients.
Phase 2
Completed
- Conditions
- Health Condition 1: null- Alcoholic Liver Disease patients
- Registration Number
- CTRI/2018/03/012644
- Lead Sponsor
- Apex Laboratories
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 24
Inclusion Criteria
1.Chronic alcohol intake patients
2.Serum AST &ALT is typically elevated to a level of 2â??6 times the upper limits of the normal.
3.Negative pregnancy test for women in reproductive age (up to two weeks prior to the study)
4.Negative for hepatitis B and C
Exclusion Criteria
1.Patients who have liver disease with the cause different from that of alcohol induced liver disease.
2.Drug dependence
3.A known hypersensitivity or allergy to any component of the drugs evaluated in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Change in AST,ALT and bilirubin values from baseline to 4 and 8 weeks as compared to Silymarin group. <br/ ><br>Timepoint: 4 th and 8th week
- Secondary Outcome Measures
Name Time Method 1.Number of Participants with Adverse Events (Safety) <br/ ><br>2.To evaluate ALT normalization <br/ ><br>3.To evaluate AST normalization <br/ ><br> <br/ ><br>Timepoint: 4th and 8th week