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A randomized, double-blind, placebo-controlled clinical study on Yinqi Sanhuang Jiedu Decoction combined with Tongluo Yanggan application in the treatment of hepatitis B-related liver fibrosis

Efficacy evaluation and mechanism study of Yiqi Huashi and Jiedu Tongluo methods in chronic liver disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2022000019
Enrollment
Unknown
Registered
2022-06-21
Start date
2022-09-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Hepatitis B-related liver fibrosis

Interventions

Treatment group:Entecavir combined with Yinqi Sanhuang Jiedu Decoction and Tongluo Yanggan application
control group:Entecavir combined with traditional Chinese medicine placebo and application placebo

Sponsors

Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for chronic hepatitis B; (2) Meet the diagnostic criteria for liver fibrosis; (3) Comply with the syndrome differentiation standard of Ganyu and Pixu; (4) The age is between 18-70 years old, and the gender is not limited; (5) Willing to participate in this research and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with fibrosis caused by other causes of chronic liver disease; (2) Acute and chronic hepatitis with non-HBV hepadnavirus infection, autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary Metabolic liver disease, drug or toxic hepatitis, alcoholic liver disease patients; (3) pregnant or lactating women and women who plan to be pregnant during the study period; (4) those who are allergic to the test drug; (5) can not cooperate with mental disorders Patients in this study, or patients with unstable epilepsy; (6) Patients with systemic diseases such as severe heart, brain, lung, kidney, and hematopoiesis; (7) Alcoholism or other unsuitable drug test observers, or In combination with treatment, it is difficult to make a definitive evaluation of the effectiveness and safety of the drug; (8) Other circumstances that the investigator believes are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Symptoms of traditional Chinese medicine;LSM;Serum Indices Of Hepatic Fibrosis;The thickness of spleen;liver function;HBV-DNA;—

Countries

China

Contacts

Public Contactlvwenliang

Guang'anmen Hospital, China Academy of Chinese Medical Sciences

lvwenliang@sohu.com18601237779

Outcome results

None listed

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