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

August 14, 2015 updated by: Beijing 302 Hospital
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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Recruiting
        • 302 Military Hospital of China
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yongping Yang, MD
        • Sub-Investigator:
          • Hongyan Li, MD
        • Sub-Investigator:
          • Jianhui Qu, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Fufang Biejia Ruangan Tablet
Fufang Biejia Ruangan Tablet will be administered to all of subjects in this arm.
Drug: Fufang Biejia Ruangan Tablet
PLACEBO_COMPARATOR: placebo
placebo of Fufang Biejia Ruangan Tablet
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Liver histological changes
Time Frame: before treatment and after 48 weeks twice
before treatment and after 48 weeks twice

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing 302 Hospital

Investigators

  • Principal Investigator: Yongping Yang, Master, Beijing 302 Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (ESTIMATE)

October 18, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 14, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2013ZX10005002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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