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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.

Phase 1
Recruiting
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
Inclusion Criteria

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.

Exclusion 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
NameTimeMethod
liver function;TCM syndrome score;
Secondary Outcome Measures
NameTimeMethod
blood routine examination;HBV DNA;HBV-M;Liver hardness number;
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