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| Name | Class |
|---|---|
| First Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Beijing Ditan Hospital | OTHER |
| Beijing YouAn Hospital | OTHER |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ornithine aspartate granule group | Experimental | 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). |
|
| silymarin capsule group | Active Comparator | 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) . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ornithine aspartate granule | Drug | Ornithine aspartate granules in the experimental arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients whose controlled attenuation parameter (CAP) value returned to normal or changed by more than 10% | Assessed at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The changed degree of quality-of-life measured by the Chronic Liver Disease Questionnaire (CLDQ)-NAFLD/NASH | 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% |
| Measure | Description | Time Frame |
|---|---|---|
| The changed amount of blood ammonia | An exploratory indicator | Assessed at 4 weeks, 12 weeks, and 24 weeks |
| The changed amount of body fat | An exploratory indicator of body composition analysis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian G Fan, PHD | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai Municipality | 200092 | China |
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| OTHER |
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| Silymarin capsule | Drug | Silymarin capsules in the active comparator arm. |
|
| Silymarin capsule simulant | Drug | Silymarin capsule simulant in the experimental arm. |
|
| Ornithine aspartate granule simulant | Drug | Ornithine aspartate granule simulant in the active comparator arm. |
|
| Assessed at 4 weeks, 12 weeks, and 24 weeks |
| Assessed at 4 weeks, 12 weeks, and 24 weeks |
| The changed amount of body fat proportion | An exploratory indicator of body composition analysis | Assessed at 4 weeks, 12 weeks, and 24 weeks |
| The changed amount of muscle mass | An exploratory indicator of body composition analysis | Assessed at 4 weeks, 12 weeks, and 24 weeks |
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012838 | Silymarin |
| ID | Term |
|---|---|
| D044947 | Flavonolignans |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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