Clinical Trial Details

Trial ID: L0735
Source ID: NCT04193982
Associated Drug: Vitamin E
Title: An Investigator Initiated Prospective, Four Arms Randomized Comparative Study of Efficacy and Safety of Saroglitazar, Vitamin E and Life Style Modification in Patients With Nonalcoholic Fatty Liver Disease (NAFLD)/ Non-alcoholic Steatohepatitis (NASH)
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: NAFLD
Interventions: Drug: Saroglitazar;Drug: Vitamin E;Drug: Combination drug;Behavioral: Lifestyle Changes
Outcome Measures: Change in Non alcoholic fatty liver fibrosis score at 8week, 16week and 24week.Serum Alanine aminotransferase (ALT) changes at 6 months.;Serum triglycerides (TG) level.;Change in fibrosis on Liver Biopsy at 6 months.;Serum Aspartate aminotransferase (AST) level at 6 months.;Non alcoholic steatosis (NAS) score on liver biopsy at 6 months.;Glycosylated Hemoglobin (HbA1C) Level at 6 months.
Sponsor/Collaborators: Asian Institute of Gastroenterology, India
Gender: All
Age: 18 Years60 Years
Phases: Phase 3
Enrollment: 250
Study Type: Interventional
Study Designs: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
Start Date: 14/08/2019
Completion Date: --
Results First Posted: --
Last Update Posted: 1 February 2021
Locations: India
URL: https://clinicaltrials.gov/show/NCT04193982