NCT04193982

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Asian Institute of Gastroenterology, India · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Saroglitazar and Vitamin E are both being extensively used in India for non alcoholic fatty liver disease, though none of these drugs are FDA approved for this indication.However they are backed up by number of studies which shows improvement in liver function , reduction in NAS score. However, there is no head to head trial , nor is there any study with a paired biopsy comparing two arms for a head to head study. We therefore designed this study to see the effect of Vitamin E vs Vitamin E plus saroglitazar vs Saroglitazar alone when compared to standard dietary and weight loss treatment for NAFLD with raised ALT levels.

Conditions

• NAFLD

Interventions

Type	Name	Description
DRUG	Saroglitazar	Patient receives Saraglitazar 4mg once daily
DRUG	Vitamin E	Patient receive Vitamin E 400mg twice daily after food for 6 months
DRUG	Combination drug	Patient receives Vitamine E 400mg twice daily and Saraglitazar 4 mg once daily for 6 months
BEHAVIORAL	Lifestyle Changes	Patients receives dietary advise and does exercise in form of aerobic and targets 7 to 10 percent weight loss in 6 months

Timeline

• Start date: 2021-01-31
• Primary completion: 2021-09-30
• Completion: 2021-10-31
• First posted: 2019-12-11
• Last updated: 2021-01-26

Locations

1 site across 1 country: India