Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis

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.

NCT Number	NCT07544121
Lead Sponsor	Nanfang Hospital, Southern Medical University Collaborators: Beijing 302 Hospital, Beijing Ditan Hospital, Shenzhen Third People's Hospital
Conditions	HEPATITIS B CHRONIC, Cirrhosis, Liver, Hepatocellular Carcinoma (HCC)
Enrollment	1,034 participants
Start Date	2026-04-01
Primary Completion	2028-04-01 (estimated)
Study Completion	2028-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-22