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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01965418
Recruitment Status : Unknown
Verified August 2015 by Beijing 302 Hospital.
Recruitment status was:  Recruiting
First Posted : October 18, 2013
Last Update Posted : August 17, 2015
Information provided by (Responsible Party):
Beijing 302 Hospital

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 .

Condition or disease Intervention/treatment Phase
Liver Fibrosis Chronic Hepatitis B Drug: Fufang Biejia Ruangan Tablet Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : September 2013
Estimated Primary Completion Date : December 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Liver histological changes [ Time Frame: before treatment and after 48 weeks twice ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01965418

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Contact: Yongping Yang, Master 0086-13601371542

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China, Beijing
302 Military Hospital of China Recruiting
Beijing, Beijing, China, 100039
Contact: Hongyan Li, MD    +8618600346925   
Contact: Feng Yu, MBBS    +861066933461   
Principal Investigator: Yongping Yang, MD         
Sub-Investigator: Hongyan Li, MD         
Sub-Investigator: Jianhui Qu, MD         
Sponsors and Collaborators
Beijing 302 Hospital
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Principal Investigator: Yongping Yang, Master Beijing 302 Hospital

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Beijing 302 Hospital Identifier: NCT01965418     History of Changes
Other Study ID Numbers: 2013ZX10005002
First Posted: October 18, 2013    Key Record Dates
Last Update Posted: August 17, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic