Clinical study for different subtypes of dampness-heat syndrome in the treatment of chronic hepatitis B with Yin-Chen-Hao Decoction: a randomized controlled trial.
- Conditions
- chronic hepatitis B
- Registration Number
- ITMCTR2000003640
- Lead Sponsor
- Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who meet the above diagnostic criteria of Western medicine and traditional Chinese medicine;
2. The age is 18-65 years old, no gender limit;
3. Patients who have taken entecavir antiviral therapy or have not taken entecavir, but meet the antiviral treatment indications;
4. Patients or their guardians agree to participate in randomized controlled trials and sign informed consent forms;
5. Healthy volunteers were patients who denied the history of chronic hepatitis;
6. All patients should be scored by experts with the title of associate chief physician or above according to the diagnostic criteria.
1. Patients who have been taking traditional Chinese medicine decoction and Chinese patent medicine for one month in the past;
2. Patients with liver cancer;
3. Patients with acute and chronic hepatitis without HBV infection;
4. Patients with mental history or uncontrollable epilepsy;
5. Patients with uncontrollable diabetes mellitus;
6. History of hemoglobin and other causes such as hemolytic anemia caused by autoimmunity;
7. Patients with serious underlying diseases, including chronic respiratory failure, circulatory failure, renal failure, etc;
8. Patients with orthotopic organ transplantation (such as liver, kidney, lung, heart) or bone marrow transplantation and stem cell transplantation;
9. Patients with immune deficiency, such as HIV infection, etc.;
10. Pregnant or lactating women and women who plan to become pregnant during the study period;
11. Patients allergic to the test drug;
12. Patients who are participating in other clinical trials;
13. Other situations that the researchers considered unsuitable for the study.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method liver function;TCM syndrome score;
- Secondary Outcome Measures
Name Time Method blood routine examination;HBV DNA;HBV-M;Liver hardness number;