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

Chronic Hepatitis B Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01965418
• Other study ID #: 2013ZX10005002
• Status: Recruiting
• Phase: Phase 4
• First received: October 16, 2013
• Last updated: August 14, 2015
• Start date: September 2013

Study information

• Verified date: August 2015
• Source: Beijing 302 Hospital
• Contact: Yongping Yang, Master
• Phone: 0086-13601371542
• Email: yongpingyang[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Fibrosis
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Liver Cirrhosis
• Liver Fibrosis

Intervention

Drug:
• Fufang Biejia Ruangan Tablet

• Placebo

Locations

Country	Name	City	State
China	302 Military Hospital of China	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver histological changes		before treatment and after 48 weeks twice	Yes