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| Name | Class |
|---|---|
| Shanghai Zhongshan Hospital | OTHER |
| Guangxi Ruikang Hospital | OTHER |
| Hubei Hospital of Traditional Chinese Medicine | OTHER |
| The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine |
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Liver Cirrhosis is a common pathological consequence of chronic liver disease. Hepatitis B Virus (HBV) is one of most etiologies of liver cirrhosis in China. The effective inhibition of HBV can partially stop or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, and the anti-fibrotic strategy focusing on the regulation of hepatic extracellular matrix is still required and hopefully improve the efficacy of anti-virals for liver fibrotic patients with HBV, especially is necessary for in the patients with advance fibrosis stage ie. liver cirrhosis. Fuzheng Huayu has been found to enhance the degradation of collagens in fibrotic liver and have a good action against liver fibrosis in patients with chronic hepatitis B. However, there are no high quality clinical evidences which can demonstrate if the combination of anti-viral and anti-fibrotic therapy can improve the reversion of liver cirrhosis due to HBV.
The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Fuzheng Huayu for the reversion of liver fibrosis in patients with liver cirrhosis due to HBV.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir + Placebo | Placebo Comparator | Tablet with Entrcavir+ Tablet with starch |
|
| Entecavir + Fuzheng Huayu Tablet | Experimental | Tablet with Entrcavir+ Tablet with Fuzheng Huayu |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir + Placebo | Drug | The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of liver fibrosis | The collagen of liver tissue from 48 week post-treatment patients was stained. 3 pathologists read the slides independently and score the slides with Ishak system. If the Ishak score decrease 1 or more than 1 score, then it is recorded as regression. | 48 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chenghai Liu, PhD | Contact | 8621-20256521 | chenghailiu@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chenghai Liu, PhD | ShuGuang Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Ruikang Hospital | Recruiting | Nanning | Guangxi | China | ||
| The Fifth Hospital of Shijiazhuang |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32572776 | Derived | Li ZX, Zhao ZM, Liu P, Zheng QS, Liu CH. Treatment of HBV Cirrhosis with Fuzheng Huayu Tablet () and Entecavir: Design of a Randomized, Double-Blind, Parallel and Multicenter Clinical Trial. Chin J Integr Med. 2021 Jul;27(7):509-513. doi: 10.1007/s11655-020-3257-6. Epub 2020 Jun 22. |
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| OTHER |
| Huai'an No. 4 People's Hospital | UNKNOWN |
| Ruijin Hospital | OTHER |
| Shenzhen Third People's Hospital | OTHER |
| Beijing Ditan Hospital | OTHER |
| Beijing YouAn Hospital | OTHER |
| China-Japan Friendship Hospital | OTHER |
| Tongji Hospital | OTHER |
| Wenzhou Central Hospital | OTHER |
| Jingmen No.1 People's Hospital | OTHER |
| Affiliated Hospital of Shandong Univercity of TCM | UNKNOWN |
| The Ninth Hospital of Nanchang | OTHER |
| The People's Hospital of Ningxia | OTHER |
| Fifth Hospital of Shijiazhuang City | OTHER |
| The Fifth People's Hospital of Suzhou | OTHER |
| The Fifth People's Hospital of Anyang | UNKNOWN |
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| Entecavir + Fuzheng Huayu Tablet | Drug | The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 48 weeks. |
|
| Recruiting |
| Shijiazhuang |
| Hebei |
| China |
| The Fifth People's Hospital of Anyang | Recruiting | Anyang | Henan | China |
| Jingmen No.1 People's Hospital | Recruiting | Jingmen | Hubei | China |
| Hubei Hospital of TCM | Recruiting | Wuhan | Hubei | China |
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
| The First Affiliated Hospital of Hunan University of TCM | Recruiting | Changsha | Hunan | China |
| Huai'an No. 4 People's Hospital | Recruiting | Huai'an | Jiangsu | China |
| The Fifth People's Hospital of Suzhou | Recruiting | Suzhou | Jiangsu | China |
| The Ninth Hospital of Nanchang | Recruiting | Nanchang | Jiangxi | China |
| Ningxia People's Hospital | Recruiting | Yinchuan | Ningxia | China |
| Affiliated Hospital of Shandong Univercity of TCM | Recruiting | Jinan | Shandong | China |
| Wenzhou Central Hospital | Recruiting | Wenzhou | Zhejiang | China |
| Beijing Ditan Hospital Capital Medical University | Recruiting | Beijing | China |
| Beijing Youan Hospital Capital Medical University | Recruiting | Beijing | China |
| China-Japan Friendship Hospital | Recruiting | Beijing | China |
| ShuGuang Hospital | Recruiting | Shanghai | 201203 | China |
|
| Ruijin Hospital | Recruiting | Shanghai | China |
| Shanghai Zhongshan Hospital | Recruiting | Shanghai | China |
| Shenzhen Third People's Hospital | Recruiting | Shenzhen | China |
| ID | Term |
|---|---|
| C413685 | entecavir |
| C532829 | fuzheng huayu |
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