Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 regress or reverse liver fibrosis in patients with chronic Hepatitis and liver cirrhosis due to HBV, however some patients keep existence or development although HBV DNA is under-detectable after anti-virals. Theses refractory liver fibrosis is required the anti-fibrotic treatment focusing on the regulation of hepatic extracellular matrix, 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 refractory liver fibrosis in liver cirrhosis due to HBV.
The primary objective of this study is to establish the safety and efficacy of the combination of Entecavir and Traditional Chinese Medicine in refractory liver fibrosis in liver cirrhosis due to HBV.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Entecavir+Fuzheng Huayu+TCM Granule | Experimental | Tablet with Entecavir+ Tablet with Fuzheng Huayu+ Granule with TCM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Entecavir+Fuzheng Huayu+TCM Granule | Drug | The subjects will be taking 1 Entecavir tablet per day, 4 Fuzheng Huayu tablets three times a day and specific Traditional Chinese Medicine granule 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| 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 |
|---|---|---|---|
| 32642592 | Derived | Chen Y, Zhao Z, Fan H, Li Z, He Y, Liu C. Safety and therapeutic effects of anti-fibrotic Traditional Chinese Medicine Fuzheng Huayu on persistent advanced stage fibrosis following 2 years entecavir treatment: Study protocol for a single arm clinical objective performance criteria trial. Contemp Clin Trials Commun. 2020 Jun 23;19:100601. doi: 10.1016/j.conctc.2020.100601. eCollection 2020 Sep. |
Not provided
Not provided
Not provided
| 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 Traditional Chinese Medicine | 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 |
|---|---|
| C572236 | ping gan |
Not provided
Not provided
Not provided