Trial record 1 of 1 for:    NCT01965418
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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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Beijing 302 Hospital
Sponsor:
Information provided by (Responsible Party):
Beijing 302 Hospital
ClinicalTrials.gov Identifier:
NCT01965418
First received: October 16, 2013
Last updated: October 17, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Liver Fibrosis
Chronic Hepatitis B
Drug: Fufang Biejia Ruangan Tablet
Drug: Placebo
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Beijing 302 Hospital:

Primary Outcome Measures:
  • Liver histological changes [ Time Frame: before treatment and after 48 weeks twice ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: September 2013
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01965418

Contacts
Contact: Yongping Yang, Master 0086-13601371542 yongpingyang@hotmail.com

Locations
China, Beijing
302 Military Hospital of China Recruiting
Beijing, Beijing, China, 100039
Contact: Hongyan Li, MD    +8618600346925    hongyanlitj@yahoo.com   
Contact: Feng Yu, MBBS    +861066933461    yfeng0530@163.com   
Principal Investigator: Yongping Yang, MD         
Sub-Investigator: Hongyan Li, MD         
Sub-Investigator: Jianhui Qu, MD         
Sponsors and Collaborators
Beijing 302 Hospital
Investigators
Principal Investigator: Yongping Yang, Master 302 Military Hospital of China
  More Information

No publications provided

Responsible Party: Beijing 302 Hospital
ClinicalTrials.gov Identifier: NCT01965418     History of Changes
Other Study ID Numbers: 2013ZX10005002
Study First Received: October 16, 2013
Last Updated: October 17, 2013
Health Authority: China: Ministry of Health

Additional relevant MeSH terms:
Fibrosis
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Liver Cirrhosis
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Pathologic Processes
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 23, 2014