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

April 19, 2026 updated by: Nanfang Hospital, Southern Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1034

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Voluntarily signed informed consent form
  2. Aged 18-65 years
  3. Traditional Chinese Medicine (TCM) syndrome type of Shi-re-du-yun
  4. Meeting the diagnostic criteria for hepatitis B-related cirrhosis
  5. aMAP score > 60

Exclusion Criteria:

  1. Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies
  2. Pregnant or lactating women
  3. Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)
  4. 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
  5. Severe cardiac, renal, respiratory, or hematopoietic system diseases
  6. Determined by the investigator to be unsuitable for participation in this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Standard antiviral therapy + Babao Dan Capsule
receive Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
Drug: Babao Dan Capsule
receive compound Babao Dan Capsule (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
Placebo Comparator: Placebo Comparator: Standard antiviral therapy + Placebo
receive Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy.
Drug: Babao Dan Capsule simulant
receive compound Babao Dan Capsule simulant (0.6 g per dose, three times daily) in addition to standard antiviral therapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hepatocellular carcinoma incidence in high-risk patients with hepatitis B-related cirrhosis during a 96-week follow-up
Time Frame: From enrollment to the end of treatment at 96 weeks
From enrollment to the end of treatment at 96 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of hepatic decompensation events
Time Frame: From enrollment to the end of treatment at 96 weeks
From enrollment to the end of treatment at 96 weeks
Trends in the four diagnostic methods of traditional Chinese medicine
Time Frame: From enrollment to the end of treatment at 96 weeks
From enrollment to the end of treatment at 96 weeks
Incidence of adverse events (AEs)
Time Frame: From enrollment to the end of treatment at 96 weeks
From enrollment to the end of treatment at 96 weeks
Incidence of serious adverse events (SAEs).
Time Frame: From enrollment to the end of treatment at 96 weeks
From enrollment to the end of treatment at 96 weeks
FIB-4 index
Time Frame: From enrollment to the end of treatment at 96 weeks
From enrollment to the end of treatment at 96 weeks
aspartate aminotransferase (AST)
Time Frame: From enrollment to the end of treatment at 96 weeks
From enrollment to the end of treatment at 96 weeks
alanine aminotransferase (ALT)
Time Frame: From enrollment to the end of treatment at 96 weeks
From enrollment to the end of treatment at 96 weeks
alpha-fetoprotein (AFP)
Time Frame: From enrollment to the end of treatment at 96 weeks
From enrollment to the end of treatment at 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

Beijing Ditan Hospital
Beijing 302 Hospital
Shenzhen Third People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2028

Study Completion (Estimated)

November 30, 2028

Study Registration Dates

First Submitted

March 15, 2026

First Submitted That Met QC Criteria

April 19, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 19, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2026-138

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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