| 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
|
