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

Beijing 302 Hospital

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis B; Liver Fibrosis

Treatments: Drug: Fufang Biejia Ruangan Tablet; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01965418

2013ZX10005002

Details and patient eligibility

About

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 .

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,000 participants in 2 patient groups, including a placebo group

Fufang Biejia Ruangan Tablet

Active Comparator group

Description:

Fufang Biejia Ruangan Tablet will be administered to all of subjects in this arm.

Treatment:

Drug: Fufang Biejia Ruangan Tablet

placebo

Placebo Comparator group

Description:

placebo of Fufang Biejia Ruangan Tablet

Treatment:

Drug: Placebo