[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100088079":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":28,"centralContacts":27,"locations":32,"responsibleParty":55,"collaborators":27,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":27,"eligibilityCriteria":64,"healthyVolunteers":60,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":27,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":78,"overallStatus":80,"whyStopped":27,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"All India Institute of Medical Sciences","OTHER",[8,13,17],{"label":9,"type":6,"description":10,"interventionNames":11},"Arm 1","Arm 1: will receive Isoniazide(5mg\u002Fkg\u002Fday), Rifampicin(10mg\u002Fkg\u002Fday) and Pyrazinamide(25mg\u002Fkg\u002Fday) in full doses on day 1 and continued further",[12],"Drug: Rifampicin(max dose 10 mg\u002Fkg\u002Fday), Isoniazide (max dose 5 mg\u002Fkg\u002Fday) and Pyrazinamide (max dose 25 mg\u002Fkg\u002Fday)",{"label":14,"type":6,"description":15,"interventionNames":16},"Arm 2","Arm 2 : will receive Rifampicin(10mg\u002Fkg\u002Fday) in full dose on day 1 and continued, Isoniazide(5mg\u002Fkg\u002Fday)in full dose on day 8 and continued, Pyrazinamide(25mg\u002Fkg\u002Fday)on day 15 and continued",[12],{"label":18,"type":6,"description":19,"interventionNames":20},"Arm 3","Arm 3 will receive 100 mg\u002Fday of Isoniazide on day 1 which is gradually increased to maximum dose (5mg\u002Fkg\u002Fday) by day 4 and continued. Rifampicin is introduced on day 8 in a dose of 150 mg\u002Fday which is gradually increased to maximum dose (10mg\u002Fkg\u002Fday) by day 11 and continued. Pyrazinamide is introduced on day 15 in a dose of 500mg\u002Fday which is gradually increased to maximum dose (25mg\u002Fkg\u002Fday) by day 18 and continued.",[12],[22],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Rifampicin(max dose 10 mg\u002Fkg\u002Fday), Isoniazide (max dose 5 mg\u002Fkg\u002Fday) and Pyrazinamide (max dose 25 mg\u002Fkg\u002Fday)","Patients who develop ATT drug induced hepatotoxicity will be divided into 3 arms .Arm 1,2,3 will be given drugs as described in detailed description of the title.",[9,14,18],null,[29],{"name":30,"affiliation":5,"role":31},"Surendra K Sharma, MD, PhD","PRINCIPAL_INVESTIGATOR",[33,46],{"facility":34,"status":27,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":27},"Sri Venkateswara Institute of Medical Sciences","Tirupati","Andhra Pradesh","517507","India","IN",{"type":41,"coordinates":42},"Point",[43,44],79.41989,13.63551,{"lat":44,"lon":43},{"facility":5,"status":27,"city":47,"state":48,"zip":49,"country":38,"countryCode":39,"cosmosGeoPoint":50,"geoPoint":54,"contacts":27},"New Delhi","National Capital Territory of Delhi","110029",{"type":41,"coordinates":51},[52,53],77.2148,28.62137,{"lat":53,"lon":52},{"type":31,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"S.K.SHARMA","Professor and Head","100088079","phase-4-study-of-safety-and-efficacy-of-different-regimes-of-reintroduction-of-anti-tb-drugs-in-anti-tb-drugs-induced-liver-damage-100088079",false,"NCT00405301","Study of Safety and Efficacy of Different Regimes of Reintroduction of Anti-TB Drugs in Anti-TB Drugs Induced Liver Damage","Study of Safety and Efficacy of Different Regimes of Reintroduction of Anti-TB Drugs in Antituberculosis Treatment Induced Hepatotoxicity","Inclusion Criteria:\n\n* A rise of five times the upper limit of the normal levels (50 IU\u002FL) of serum aspartate aminotransferase (AST) and\u002For alanine aminotransferase (ALT)\n* A rise in the level of serum total bilirubin level \\> 1.5mg\u002Fdl\n* Any increase in serum AST and or ALT above pretreatment values together with anorexia, nausea, vomiting and jaundice\n* Absence of serological evidence of infection with hepatitis viruses A,B,C,or E\n* Normalization of liver function tests after withdrawal of antituberculosis drugs For diagnosis of anti-TB drugs induced hepatitis, criteria 1 or 2 or 3 should be present along with criteria 4 and 5.\n\nExclusion Criteria:\n\n* Patients with serological evidence of acute viral hepatitis A,B,C,or E and carriers for HBV \\& HCV\n* Age \\\u003C 15 year and age \\> 65 years\n* HIV positive patients\n* Presence of chronic liver disease or cirrhosis\n* Co-administration of other potential hepatotoxic drugs (methotrexate, phenytoin, valproate)\n* Chronic alcoholics who consume \\> 48 g of alcohol\u002Fday for at least one year\n* Pregnant women\n* Subjects not giving consent","ALL","16 Years","65 Years",{"count":69,"type":70},175,"ACTUAL","INTERVENTIONAL",[73],"PHASE4","Purpose of the study is to evaluate the safety and efficacy of different re-introduction regimens in anti-TB drug induced liver damage. There is no consensus how best to treat such patients who developed drug induced liver damage.",[76,77],"Drug Induced Hepatotoxicity","Tuberculosis",[77,76,79,38],"Anti-tuberculosis drugs","COMPLETED","2012-02-14",{"date":83,"type":84},"2012-02-16","ESTIMATED",{"date":86,"type":27},"2006-12",{"date":88,"type":70},"2008-12",{"name":5,"class":6},2]