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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.

Clinical study for different subtypes of dampness-heat syndrome in the treatment of chronic hepatitis B with Yin-Chen-Hao Decoction

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003640
Enrollment
Unknown
Registered
2020-08-21
Start date
2020-08-20
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic hepatitis B

Interventions

Sponsors

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
liver function;TCM syndrome score;

Secondary

MeasureTime frame
blood routine examination;HBV DNA;HBV-M;Liver hardness number;

Countries

China

Contacts

Public ContactMingyu Sun

Shuguang Hospital Affiliated to Shanghai University of traditional Chinese Medicine

mysun369@126.com+86 13918746358

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026