NCT05042245

The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules

The Efficacy and Safety of Ornithine Aspartic Acid Granules in Non-Alcoholic Fatty Liver Disease Against Silymarin Capsules: a Randomized, Double-Blind, Multicenter Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, double-dummy, and positive control clinic trial which explores the efficacy and safety of ornithine aspartate granules in the treatment of non-alcoholic fatty liver disease against silymarin capsules. The hypothesis is that the ornithine aspartate granules have similar or better efficacy than the silymarin capsules.

Conditions

• Non-alcoholic Fatty Liver Disease

Interventions

Type	Name	Description
DRUG	Ornithine aspartate granule	Ornithine aspartate granules in the experimental arm.
DRUG	Silymarin capsule	Silymarin capsules in the active comparator arm.
DRUG	Silymarin capsule simulant	Silymarin capsule simulant in the experimental arm.
DRUG	Ornithine aspartate granule simulant	Ornithine aspartate granule simulant in the active comparator arm.

Timeline

• Start date: 2019-07-23
• Primary completion: 2022-12-18
• Completion: 2022-12-20
• First posted: 2021-09-13
• Last updated: 2026-03-16

Locations

1 site across 1 country: China