[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557435":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":28,"centralContacts":45,"locations":51,"responsibleParty":68,"collaborators":71,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":28,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":54,"whyStopped":28,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"A1=Experimental:","EXPERIMENTAL","Drug: Oral BCAA + Rifaximin placebo + Lactulose ( Oral BCAA 15 gm in once daily dose With Lactulose for 12 weeks)",[13,14,15],"Drug: Oral Branched chain Amino acid","Drug: Lactulose","Drug: Placebo for Rifaximin 550mg",{"label":17,"type":10,"description":18,"interventionNames":19},"A2= Experimental:","Drug: Rifaximin+ BCAA Placebo + Lactulose ( Oral Rifaximin 550 mg twice daily daily + Lactulose therapy for 12 weeks)",[20,14,21],"Drug: Rifaximin 550 MG","Drug: Placebo for BCAA",[23,29,33,37,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Oral Branched chain Amino acid","The active drug BCAA supplement will be dispensed in a dose of 15 gm once daily x 12 weeks",[9],null,{"type":24,"name":30,"description":31,"armGroupLabels":32,"otherNames":28},"Rifaximin 550 MG","Active drug rifaximin will be dispensed in a dose of 550mg twice daily x 12 weeks",[17],{"type":24,"name":34,"description":35,"armGroupLabels":36,"otherNames":28},"Lactulose","Both groups will be treated with will be treated with 30-60 ml lactulose three times a day to ensure passage of 2-3 semisoft stools per day",[9,17],{"type":24,"name":38,"description":39,"armGroupLabels":40,"otherNames":28},"Placebo for BCAA","A placebo comparator of 15 gm of skimmed milk powder will be used.",[17],{"type":24,"name":42,"description":43,"armGroupLabels":44,"otherNames":28},"Placebo for Rifaximin 550mg","Identical placebo sugar pills will be used as a placebo.",[9],[46],{"name":47,"role":48,"phone":49,"phoneExt":28,"email":50},"Madhumita Premkumar","CONTACT","+9101722754777","drmadhumitap@gmail.com",[52],{"facility":53,"status":54,"city":55,"state":28,"zip":28,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"PGIMER","RECRUITING","Chandigarh","India","IN",{"type":59,"coordinates":60},"Point",[61,62],76.7884,30.73629,{"lat":62,"lon":61},[65],{"name":66,"role":48,"phone":49,"phoneExt":28,"email":67},"Anchal Sandhu","anchalsandhu04@gmail.com",{"type":69,"investigatorFullName":47,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":28,"oldOrganization":28},"PRINCIPAL_INVESTIGATOR","ASSOCIATE PROFESSOR",[72],{"name":73,"class":74},"Indian Council of Medical Research","OTHER_GOV","100557435","phase-4-bcaa-vs-rifaximin-in-patients-with-cirrhosis-for-secondary-prophylaxis-of-he-100557435",false,"NCT06538077","BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE","Branch Chain Amino Acids vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of Hepatic Encephalopathy: Double-blind Placebo-controlled Multicentric Randomized Controlled Trial","HERB","Inclusion Criteria:\n\n1. Cirrhosis defined by standard clinical, ultrasonographic findings and\u002For histological criteria. Cirrhosis of any etiology may be included. However, patients with cirrhosis due to autoimmune hepatitis must be on stable corticosteroid doses for ≥3-month period before study inclusion; those with viral hepatitis, must similarly be on anti-viral therapy with controlled viremia or with SVR.\n2. Any gender\n3. Discharged from the hospital following an episode of overt hepatic encephalopathy.\n4. Participants able to give informed consent\n\nExclusion Criteria:\n\n1. Subjects with active bacterial or fungal infection\n2. Subjects with active or very recent gastrointestinal bleeding in the last 2 weeks.\n3. Current overt hepatic encephalopathy, defined as grade II-IV hepatic encephalopathy according to the West-Haven classification.\n4. Conditions that can impact interpretation of cognitive function:\n\n   i) Untreated viremic hepatitis C virus infection ii) Established neurological\u002Fdegenerative disorders iii) Patient undergoing active alcohol withdrawal treatment Iv) Patient is intoxicated or under the influence of illicit drugs as per clinician assessment V) Treatment with antipsychotics or other psychotropic drugs with sedative effects\n5. Patients with active hepatocellular carcinoma or history of hepatocellular carcinoma that is in remission for less than six months.\n6. Patients with a history of significant extrahepatic disease with impaired short-term prognosis, including: i) Congestive heart failure New York Heart Association Grade III\u002FIV or ejection fraction\\\u003C30% ii) COPD: GOLD \\>2, ii) Chronic kidney disease with serum creatinine \\>2mg\u002FdL or under renal replacement therapy.\n7. Patients with current extra hepatic malignancies, including solid tumours and hematologic disorders.\n8. Patients with MELD\\>20\n9. Patients with mental incapacity, or those unlikely to survive 12 weeks or any other reason considered by the investigator precluding adequate understanding, cooperation, or compliance in the study activities.\n10. Patients with TIPS shunt in situ\n11. Pregnancy (urine pregnancy test at inclusion)\n12. Refusal or inability to give informed consent","ALL","18 Years","65 Years",{"count":87,"type":88},336,"ESTIMATED","INTERVENTIONAL",[91],"PHASE4","Rationale\n\n* Patients who recover from an episode of overt HE(OHE) are at risk of recurrent episodes of HE and persistent minimal hepatic encephalopathy, impacting their daily functioning and mental health.\n* A multicentric pan-India team will evaluate the role of oral branched-chain amino acids (BCAA) vs Rifaximin as secondary prophylaxis following overt HE as compared with improvement in cognitive function.\n\nNovelty:\n\n* This study is intended to investigate the role of BCAA vs rifaximin as the ideal second-line therapy for HE management, recurrence, and overall health, including cognitive function, depression and anxiety.\n* The head-to-head comparison of BCAA+lactulose+ pill-placebo vs rifaximin+ lactulose+ powder-placebo ensures minimization of bias and has adequate power to determine rates of recurrence,\n\nObjectives:\n\n* To assess the 1st breakthrough episode of HE during 6months in BCAA vs rifaximin groups as ideal secondary prophylaxis in HE. Methodology\n* Double-blind placebo-controlled double-dummy randomized trial of BCAA supplementation vs rifaximin as the ideal second-line therapy in patients with cirrhosis who have recovered from an episode of OHE. Expected Outcome\n* Ideal second line agent HE prophylaxis (rifaximin or BCAA) following 1st line lactulose is unclear in an Indian context where dysbiosis and sarcopenia are prevalent, and cost of therapy needs to be optimized.\n* Optimal HE management prevents recurrence episodes of HE, and improves prognosis, neurocognitive function, and overall health-related quality of life(HRQOL).\n* Creation of a management algorithm based deductive models incorporating etiology and severity of liver disease, cognitive performance, sarcopenia, and ammonia, and neuropsychiatric impact of using BCAA vs Rifaximin will be created.",[94,95,96],"Hepatic Encephalopathy","Decompensated Cirrhosis","Minimal Hepatic Encephalopathy",[98,99,100,101,102],"Hepatic encephalopathy","Branched-chain amino acids","Computerized neurocognitive test battery","Double blind placebo controlled multicentric randomized controlled trial","rifaximin","2025-06-05",{"date":105,"type":106},"2025-06-10","ACTUAL",{"date":108,"type":106},"2025-02-01",{"date":110,"type":88},"2027-08",{"name":5,"class":6},1]