A Phase 4 interventional study of Ornithine aspartate granule and Silymarin capsule in Non-alcoholic Fatty Liver Disease, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-03-16.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Phase 4, Interventional, and Treatment
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.
1,474 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 303 are open to participants now.
This study's enrollment of 237 is above the median of 60 across 1,072 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 222 studies on the registry; 54 are open to participants now.
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Exclusion Criteria:
Patients in this group will be given aspartate ornithine granules (3 g po tid, after three meals) and silymarin capsule simulant (140 mg po bid, before breakfast and dinner).
Drug: Ornithine aspartate granule · Drug: Silymarin capsule simulant
Patients in this group will be given silymarin capsule (140 mg po bid, before breakfast and dinner) and aspartate ornithine granules simulant (3 g po tid, after three meals) .
Drug: Silymarin capsule · Drug: Ornithine aspartate granule simulant
Ornithine aspartate granules in the experimental arm.
Silymarin capsules in the active comparator arm.
Silymarin capsule simulant in the experimental arm.
Ornithine aspartate granule simulant in the active comparator arm.
The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10%
Time frame: Assessed at 24 weeks
The changed degree of quality-of-life measured by the Chronic Liver Disease Questionnaire (CLDQ)-NAFLD/NASH
Time frame: Assessed at 4 weeks, 12 weeks, and 24 weeks
The proportion of patients whose alanine aminotransferase (ALT) level returned to normal or changed by more than 50%
Time frame: Assessed at 4 weeks, 12 weeks, and 24 weeks
The changed amount of blood ammonia
An exploratory indicator
Time frame: Assessed at 4 weeks, 12 weeks, and 24 weeks
The changed amount of body fat
An exploratory indicator of body composition analysis
Time frame: Assessed at 4 weeks, 12 weeks, and 24 weeks
The changed amount of body fat proportion
An exploratory indicator of body composition analysis
Time frame: Assessed at 4 weeks, 12 weeks, and 24 weeks
The changed amount of muscle mass
An exploratory indicator of body composition analysis
Time frame: Assessed at 4 weeks, 12 weeks, and 24 weeks
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Non-alcoholic Fatty Liver Disease→
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine