NCT07544121Not yet recruiting
Effect of Babao Dan Capsule Combined With Antiviral Therapy on the Incidence of Hepatocellular Carcinoma in Patients With Hepatitis B-related Cirrhosis
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
Source: ClinicalTrials.gov · Last updated 22 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1034 (estimated)
- First submitted
- 15 Mar 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 1 Apr 2028
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- NCT number
- NCT07544121
What you commit to
- Study type: Interventional
- Planned participants: 1034
- From 1 Apr 2026 to the primary completion date, 1 Apr 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies
- 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
Other illness
- Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)
- Severe cardiac, renal, respiratory, or hematopoietic system diseases
Other
- Pregnant or lactating women
- Determined by the investigator to be unsuitable for participation in this trial
Who the study is looking for
- 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
- aMAP score \> 60
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.