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This research puts liver biopsy as the enrollment screening criteria and the primary efficacy assessment indicators. Patients at different developmental stages of hepatitis B related liver fibrosis are respectively diagnosed and treated by Traditional Chinese medicine to determine optional diagnosis and treatment plan of traditional Chinese medicine to screen the advantage-treated population and to establish a treatment program, which can save national medical resources, for clinical application of Traditional Chinese medicine Diagnosis and Treatment blocking and reversing hepatitis B-related liver fibrosis. The research can help to build automation pathological analysis and diagnosis systems and non-invasive clinical assessment criteria and models of liver fibrosis which can be applied in clinical. It can also help to realize electronic patient data collection and management, to establish patients management centre and follow-up database. Then it will help to improve clinical efficacy of being blocked and reversed chronic hepatitis B related liver fibrosis by Chinese medicine Diagnosis and Treatment program, to reduce the incidence of liver cirrhosis and hepatitis B-related mortality, to prolong patients' survival and improve patients' quality of life, to make clinical efficacy, which is about Traditional Chinese Medicine blocking and revering chronic hepatitis B-related liver fibrosis, increase by 15% or more .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fufang Biejia Ruangan Tablet | Active Comparator | Fufang Biejia Ruangan Tablet will be administered to all of subjects in this arm. |
|
| placebo | Placebo Comparator | placebo of Fufang Biejia Ruangan Tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fufang Biejia Ruangan Tablet | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Liver histological changes | before treatment and after 48 weeks twice |
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Inclusion Criteria:
Inclusion criteria of chronic hepatitis B related liver fibrosis:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yongping Yang, Master | Contact | 0086-13601371542 | yongpingyang@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yongping Yang, Master | Beijing 302 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 302 Military Hospital of China | Recruiting | Beijing | Beijing Municipality | 100039 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41877798 | Derived | Li M, Hao X, Li Y, Zhang C, Chen Y, Yu Z, Li Q, Tan L, Xiang D, Shang Q, Lei C, Chen L, Hu X, Wang J, Liu H, Lu W, Chen Y, Dong Z, Bai W, Yoshida EM, Mendez-Sanchez N, Hu KQ, Qi X, Yang Y, Bi J. Ishak stage 6 fibrosis is more likely to regress than stage 5 in CHB patients undergoing entecavir therapy. Front Med (Lausanne). 2026 Mar 9;13:1765594. doi: 10.3389/fmed.2026.1765594. eCollection 2026. | |
| 32437567 |
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|
| Derived |
| Rong G, Chen Y, Yu Z, Li Q, Bi J, Tan L, Xiang D, Shang Q, Lei C, Chen L, Hu X, Wang J, Liu H, Lu W, Chen Y, Dong Z, Bai W, Yoshida EM, Mendez-Sanchez N, Hu KQ, Qi X, Yang Y. Synergistic Effect of Biejia-Ruangan on Fibrosis Regression in Patients With Chronic Hepatitis B Treated With Entecavir: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial. J Infect Dis. 2022 Mar 15;225(6):1091-1099. doi: 10.1093/infdis/jiaa266. |
| 25381721 | Derived | Qu J, Yu Z, Li Q, Chen Y, Xiang D, Tan L, Lei C, Bai W, Li H, Shang Q, Chen L, Hu X, Lu W, Li Z, Chen D, Wang X, Zhang C, Xiao G, Qi X, Chen J, Zhou L, Chen G, Li Y, Zeng Z, Rong G, Dong Z, Chen Y, Lou M, Wang C, Lu Y, Zhang C, Yang Y. Blocking and reversing hepatic fibrosis in patients with chronic hepatitis B treated by traditional Chinese medicine (tablets of biejia ruangan or RGT): study protocol for a randomized controlled trial. Trials. 2014 Nov 10;15:438. doi: 10.1186/1745-6215-15-438. |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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