[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629927":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":39,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":26,"eligibilityCriteria":51,"healthyVolunteers":48,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":26,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":26,"overallStatus":66,"whyStopped":26,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":26},{"fullName":5,"class":6},"Nanfang Hospital, Southern Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: Standard antiviral therapy + Biejia-Ruangan compound","EXPERIMENTAL","receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy.",[13],"Drug: Biejia-Ruangan compound",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Comparator: Standard antiviral therapy + Placebo","PLACEBO_COMPARATOR","receive Bie-jia-ruan-gan simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy",[19],"Drug: Biejia-Ruangan compound simulant",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Biejia-Ruangan compound","receive Biejia-Ruangan compound (2.0 g per dose, three times daily) in addition to standard antiviral therapy",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Biejia-Ruangan compound simulant","receive Biejia-ruangan compound simulant (2.0 g per dose, three times daily) in addition to standard antiviral therapy",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Rong Fan","CONTACT","020-62786534","rongfansmu@163.com",{"type":38,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[40,42,44],{"name":41,"class":6},"Shenzhen Third People's Hospital",{"name":43,"class":6},"Beijing Ditan Hospital",{"name":45,"class":6},"Beijing 302 Hospital","100629927","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-100629927",false,"NCT07481032","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","Inclusion Criteria:\n\n* Voluntarily signed informed consent form\n* Aged 18-65 years\n* Traditional Chinese Medicine (TCM) syndrome type: Qi-zhi -xue-yu\n* Meeting the diagnostic criteria for hepatitis B-related cirrhosis\n* aMAP score \\> 60\n\nExclusion Criteria:\n\n* \\[Previously diagnosed with or treated for hepatocellular carcinoma (HCC) or other malignancies\n* Pregnant or lactating women\n* Decompensated cirrhosis (e.g., presence of obvious ascites, hepatic encephalopathy, or gastrointestinal bleeding)\n* 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\n* Severe cardiac, renal, respiratory, or hematopoietic system diseases\n* Determined by the investigator to be unsuitable for participation in this trial","ALL","18 Years","65 Years",{"count":56,"type":57},1034,"ESTIMATED","INTERVENTIONAL",[60],"NA","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.",[63,64,65],"Cirrhosis, Liver","Hepatocellular Carcinoma (HCC)","HEPATITIS B CHRONIC","NOT_YET_RECRUITING","2026-03-15",{"date":69,"type":70},"2026-03-18","ACTUAL",{"date":72,"type":57},"2026-04-01",{"date":74,"type":57},"2028-11-30",{"name":5,"class":6}]