This study aims to establish a prospective, multicenter, randomized, double-blind, placebo-controlled parallel-group clinical trial cohort. The cohort will include high-risk populations for hepatitis B cirrhosis-related hepatocellular carcinoma (HCC) from multiple centers nationwide, who meet the criteria of traditional Chinese medicine syndrome differentiation as Shi-re-du-yun syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Babao Dan Capsule with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.
Voluntarily signed informed consent form
Aged 18-65 years
Traditional Chinese Medicine (TCM) syndrome type of Shi-re-du-yun
Meeting the diagnostic criteria for hepatitis B-related cirrhosis
Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies
Pregnant or lactating women
Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)
Concomitant liver diseases, including but not limited to hepatitis C virus infection, human immunodeficiency virus infection, alcoholic liver disease, autoimmune liver disease, or drug-induced liver injury
Nanfang Hospital, Southern Medical University
Lead sponsor
Beijing 302 Hospital
Collaborator
Beijing Ditan Hospital
Collaborator
Shenzhen Third People's Hospital
Collaborator