Clinical trial · Interventional
Effect of Fufang Biejiaruangan 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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 Qi-zhi-xue\_yu syndrome and have an aMAP score \>60 points. The objective is to evaluate whether combining Bie-jia-ruan-gan with standard anti-hepatitis B virus therapy can further reduce the incidence of HCC in this high-risk population.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis, Liver | — | UNRESOLVED | — |
| HEPATITIS B CHRONIC | — | UNRESOLVED | — |
| Hepatocellular Carcinoma (HCC) | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biejia-Ruangan compound | Drug | — | UNRESOLVED |
| Biejia-Ruangan compound simulant | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental: Standard antiviral therapy + Biejia-Ruangan compound
- description
- receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy.
- interventionNames
- Drug: Biejia-Ruangan compound
- type
- PLACEBO_COMPARATOR
- label
- Placebo Comparator: Standard antiviral therapy + Placebo
- description
- receive Bie-jia-ruan-gan simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy
- interventionNames
- Drug: Biejia-Ruangan compound simulant
Primary outcomes (1)
- measure
- Incidence of HCC confirmed by imaging or histology at Week 96 of follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntarily signed informed consent form * Aged 18-65 years * Traditional Chinese Medicine (TCM) syndrome type: Qi-zhi -xue-yu * Meeting the diagnostic criteria for hepatitis B-related cirrhosis * aMAP score \> 60 Exclusion Criteria: * \[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 * Severe cardiac, renal, respiratory, or hematopoietic system diseases * Determined by the investigator to be unsuitable for participation in this trial
References
Publications (0)
Data not yet available