Clinical trial NCT01965418: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Liver Fibrosis
Chronic Hepatitis B
Lead sponsor: Beijing 302 Hospital
Sponsor class: OTHER
First posted: 2013-10-18
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .


Eligibility criteria: Inclusion Criteria:

Inclusion criteria of chronic hepatitis B related liver fibrosis:

1. Age from 18 to 65 years old, male or female;
2. Consistent with the diagnosis criteria of chronic hepatitis B;
3. liver fibrosis(liver biopsy) stage F ≥ 3 (Ishak), HBV DNA ≥ 104 copies / ml (or ≥ 2000 IU / ml) were;
4. TCM syndrome type: blood stasis, blood deficiency with toxic heat retention;
5. Not taking over nucleoside antiviral in one year, no drug treatment of liver fibrosis in six months;
6. Signed informed consent.

Exclusion Criteria:

1. liver fibrosis(Liver biopsy) stage F \<3 (Ishak);
2. Combined with other severe chronic hepatitis, cirrhosis, liver cancer and other severe or end-stage liver disease;
3. Accompanied by uncontrollable heart, kidney, lung, endocrine, blood, metabolic and gastrointestinal serious primary disease; or mental illness;
4. Pregnant or lactating women;
5. Patients with allergic constitution or allergic to TCM used;
6. Not be prescribed medication, poor compliance, incomplete data affecting the efficacy and safety of those judgments;
7. Patients unsuitable for this trial in Researchers' consideration;
8. Co-infection with other viral liver disease.

Primary outcomes:
measure: Liver histological changes
timeFrame: before treatment and after 48 weeks twice
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: 302 Military Hospital of China
state: Beijing
Study officials:
affiliation: Beijing 302 Hospital
name: Yongping Yang, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.