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Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis
Sponsor: Nanfang Hospital, Southern Medical University
Summary
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.
Official title: Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis: A Multicenter, Randomized, Placebo-controlled Study
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
1034
Start Date
2026-04-01
Completion Date
2028-11-30
Last Updated
2026-04-22
Healthy Volunteers
No
Interventions
Babao Dan Capsule
receive compound Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
Babao Dan Capsule simulant
receive compound Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy.