| Trial ID: | L0060 |
| Source ID: | NCT05042245
|
| Associated Drug: |
Ornithine Aspartic Acid Granules
|
| Title: |
The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules
|
| Acronym: |
--
|
| Status: |
Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Non-alcoholic Fatty Liver Disease
|
| Interventions: |
Drug: Ornithine aspartate granule|Drug: Silymarin capsule|Drug: Silymarin capsule simulant|Drug: Ornithine aspartate granule simulant
|
| Outcome Measures: |
The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10%|The changed degree of quality-of-life measured by the Chronic Liver Disease Questionnaire (CLDQ)-NAFLD/NASH|The proportion of patients whose alanine aminotransferase (ALT) level returned to normal or changed by more than 50%
|
| Sponsor/Collaborators: |
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine|First Affiliated Hospital, Sun Yat-Sen University|Beijing Ditan Hospital|Beijing YouAn Hospital|Wuhan Union Hospital, China
|
| Gender: |
All
|
| Age: |
18 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 4
|
| Enrollment: |
240
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
April 26, 2019
|
| Completion Date: |
June 2022
|
| Results First Posted: |
--
|
| Last Update Posted: |
September 21, 2021
|
| Locations: |
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai, China
|
| URL: |
https://ClinicalTrials.gov/show/NCT05042245
|
