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This study will evaluate the efficacy and safety and the best effective dose of HuHuangLianzonggan capsule in subjects with nonalcoholic steatohepatitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | HuHuangLianzonggan capsule, 4 pills, take orally after meals, 2 times a day |
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| Placebo group | Placebo Comparator | HuHuangLianzonggan capsule placebo, 4 pills, take orally after meals, 2 times a day |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HuHuangLianzonggan capsule | Drug | HuHuangLianzonggan capsule, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in hepatic fat fraction assessed by MRI-PDFF at week 12. | Week 12 | |
| Proportion of subjects with ≥ 30% relative fat reduction on MRI-PDFF at week 12. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in weight at week 4, 12. | Week 4, 12 | |
| Change from baseline in Body Mass Index (BMI) at week 4, 12. | Week 4, 12 | |
| Change from baseline in waist hip rate at week 4, 12. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Not yet recruiting | Hefei | Anhui | China |
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| HuHuangLianzonggan capsule placebo | Drug | HuHuangLianzonggan capsule placebo, 4 pills(120 mg per pill), take orally after meals, 2 times a day for 12weeks |
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| Week 4, 12 |
| Change from baseline in fasting blood glucose at week 4, 12. | Week 4, 12 |
| Change from baseline in 2 hours postprandial hyperglycemia at week 4, 12. | Week 4, 12 |
| Change from baseline in homeostasis model assessment-insulin resistance (HOMA-IR) at week 4, 12. | Week 4, 12 |
| Change from baseline in Total Cholestrol (TC) at week 4, 12. | Week 4, 12 |
| Change from baseline in triglyceride (TG) at week 4, 12. | Week 4, 12 |
| Change from baseline in Low Density Lipoprotein Cholesterol (LDL-C) at week 4, 12. | Week 4, 12 |
| Change from baseline in High Density Lipoprotein Cholesterol (HDL-C) at week 4, 12. | Week 4, 12 |
| Change from baseline in Glycosylated hemoglobin A1c (HbA1c) at week 12. | Week 12 |
| Change from baseline in Alanine aminotransferase (ALT) at week 4, 12. | Week 4, 12 |
| Change from baseline in Aspartate aminotransferase (AST) at week 4, 12. | Week 4, 12 |
| Change from baseline in total bilirubin (TBil) at week 4, 12. | Week 4, 12 |
| Change from baseline in Cytokeratin18 (CK-18) at week 4, 12. | Week 4, 12 |
| Change from baseline in N-terminal type Ⅲ collagen propeptide (Pro-C3) at week 4, 12. | Week 4, 12 |
| Change from baseline in Fibrosis 4 score at week 4, 12. | Week 4, 12 |
| Change from baseline in Chronic Liver Disease-NAFLD questionnaire (CLDQ-NAFLD) at week 4, 12. | Week 4, 12 |
| Change from baseline in ferritin at week 4, 12. | Week 4, 12 |
| The Second Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | China |
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| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | China |
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| The first affiliated hospital of Fujian medical university | Not yet recruiting | Fuzhou | Fujian | China |
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| Nanfang Hospital, Southern Medical University | Not yet recruiting | Guangzhou | Guangdong | China |
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| The Third People's Hospital of Shenzhen | Recruiting | Shenzhen | Guangdong | China |
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| The First Affiliated Hospital of Henan University of Science and Technology | Recruiting | Luoyang | Henan | China |
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| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
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| The First People's Hospital of Lianyungang | Recruiting | Lianyungang | Jiangsu | China |
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| The Affiliated Hospital of Nanjing University medical school,Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | China |
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| The Second Hospital of Nanjing | Recruiting | Nanjing | Jiangsu | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | China |
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| General Hospital of Ningxia Medical University | Not yet recruiting | Yinchuan | Ningxia | China |
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| Sichuan Provincial People's Hospital | Recruiting | Chengdu | Sichuan | China |
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| Tianjin Second People's Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| The Affiliated Hospital of Hangzhou Normal University | Recruiting | Hangzhou | Zhejiang | China |
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| Ningbo Huamei Hospital, University of Chinese Academy of Sciences | Recruiting | Ningbo | Zhejiang | China |
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| Ningbo Medical Center Lihuili Hospital | Recruiting | Ningbo | Zhejiang | China |
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| Taizhou Municipal Hospital | Recruiting | Taizhou | Zhejiang | China |
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| Rui'an People's Hospital | Recruiting | Wenzhou | Zhejiang | China |
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