drugset / Trial / NCT05042245
The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules
Phase 4
Completed
237 enrolled
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Beijing Ditan Hospital · collabBeijing YouAn Hospital · collabFirst Affiliated Hospital, Sun Yat-Sen University · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2019-07-23
- Primary completion
- 2022-12-18
- Completion
- 2022-12-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | L-ornithine L-aspartate | Other / unclassified | 3 g | Oral |
| Comparator | Silymarin | Traditional medicine (herbal / TCM) | 140 mg | Oral |