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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

Early Phase 1
Conditions
Hepatitis B-related liver fibrosis
Registration Number
ITMCTR2022000019
Lead Sponsor
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
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

(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.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Symptoms of traditional Chinese medicine;LSM;Serum Indices Of Hepatic Fibrosis;The thickness of spleen;liver function;HBV-DNA;
Secondary Outcome Measures
NameTimeMethod
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