A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial
1 other identifier
interventional
1,000
1 country
1
Brief Summary
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
October 16, 2013
CompletedFirst Posted
Study publicly available on registry
October 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedAugust 17, 2015
August 1, 2015
2.2 years
October 16, 2013
August 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Liver histological changes
before treatment and after 48 weeks twice
Study Arms (2)
Fufang Biejia Ruangan Tablet
ACTIVE COMPARATORFufang Biejia Ruangan Tablet will be administered to all of subjects in this arm.
placebo
PLACEBO COMPARATORplacebo of Fufang Biejia Ruangan Tablet
Interventions
Eligibility Criteria
You may qualify if:
- Age from 18 to 65 years old, male or female;
- Consistent with the diagnosis criteria of chronic hepatitis B;
- liver fibrosis(liver biopsy) stage F ≥ 3 (Ishak), HBV DNA ≥ 104 copies / ml (or ≥ 2000 IU / ml) were;
- TCM syndrome type: blood stasis, blood deficiency with toxic heat retention;
- Not taking over nucleoside antiviral in one year, no drug treatment of liver fibrosis in six months;
- Signed informed consent.
You may not qualify if:
- liver fibrosis(Liver biopsy) stage F \<3 (Ishak);
- Combined with other severe chronic hepatitis, cirrhosis, liver cancer and other severe or end-stage liver disease;
- Accompanied by uncontrollable heart, kidney, lung, endocrine, blood, metabolic and gastrointestinal serious primary disease; or mental illness;
- Pregnant or lactating women;
- Patients with allergic constitution or allergic to TCM used;
- Not be prescribed medication, poor compliance, incomplete data affecting the efficacy and safety of those judgments;
- Patients unsuitable for this trial in Researchers' consideration;
- Co-infection with other viral liver disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
302 Military Hospital of China
Beijing, Beijing Municipality, 100039, China
Related Publications (2)
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.
PMID: 32437567DERIVEDQu 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.
PMID: 25381721DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yongping Yang, Master
Beijing 302 Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2013
First Posted
October 18, 2013
Study Start
September 1, 2013
Primary Completion
December 1, 2015
Last Updated
August 17, 2015
Record last verified: 2015-08