[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597407":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":31,"responsibleParty":54,"collaborators":31,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":61,"acronym":31,"eligibilityCriteria":62,"healthyVolunteers":59,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":31,"studyType":69,"phases":70,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":78,"whyStopped":31,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":31},{"fullName":5,"class":6},"Liaquat National Hospital & Medical College","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"group C","ACTIVE_COMPARATOR","patients taking antituberculous drugs only",[13],"Drug: Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)",{"label":15,"type":16,"description":17,"interventionNames":18},"group A","EXPERIMENTAL","patients taking antituberculous drugs with silymarin",[19],"Drug: Silymarin 420 mg",{"label":21,"type":16,"description":22,"interventionNames":23},"group B","patients taking antituberculous drugs with N-acetylcysteine",[24],"Drug: N Acetyl Cysteine",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Silymarin 420 mg","silymarin group received silymarin 140mg thrice daily along with antituberculous drugs for 14 days",[15],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"N Acetyl Cysteine","N- acetylcysteine group will receive N-acetylcysteine 900mg once daily with antituberculous drugs for 14 days",[21],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Rifampicin (RMP) Ethambutol (E) Isoniazid (H) Pyrazinamid (Z)","Antituberculous drugs only",[9],[41],{"name":42,"affiliation":5,"role":43},"Ariba Sultan","PRINCIPAL_INVESTIGATOR",[45,50],{"name":46,"role":47,"phone":48,"phoneExt":31,"email":49},"Ariba Sultan, MBBS","CONTACT","+92 302 9887711","aaribasultan@gmail.com",{"name":51,"role":47,"phone":52,"phoneExt":31,"email":53},"shameem behram khan, fcps","+92 332 2397924","drshameem26@yahoo.com",{"type":43,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Ariba SULTAN","Principal investigator","100597407","phase-1-comparison-of-the-outcome-of-treatment-with-silymarin-or-n-aceylcysteine-in-patients-taking-anti-tuberculous-drugs-for-tuberculosis-at-a-tertiary-care-hospital--karachi-100597407",false,"NCT07058090","Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi","Inclusion Criteria:\n\n* Patients presenting with tuberculosis and previously not on any anti-tuberculous drugs, between 40-80 years of age\n* either gender.\n\nExclusion Criteria:\n\n* History of malignancy.\n* Patients with history of seropositive, seronegative, connective tissue disorder or vasculitis, congestive cardiac failure.\n* Patients with history of alcohol use.\n* Discontinuation of drug due to other adverse effects except hepatotoxicity.\n* Inadequate date of laboratory testing at baseline or 2 to 4 weeks after treatment initiation.\n* Cases with human immunodeficiency virus (HIV) co-infection, viral hepatitis, or suspected mal absorption (e.g., gastrointestinal disease or diarrhea).\n* Chronic liver disease, COPD, asthma, myocardial infarction, chronic kidney disease and stroke.","ALL","40 Years","80 Years",{"count":67,"type":68},410,"ESTIMATED","INTERVENTIONAL",[71],"PHASE1","OBJECTIVE : To compare the outcome of treatment with silymarin or N-acetyl cysteine in patients taking anti-tuberculous drugs for tuberculosis at Tertiary Care Hospital, Karachi.\n\nSAMPLE SELECTION : Patients presenting with tuberculosis previously not on anti-tuberculous drugs, between 40-80 years of age, both genders will be included .Patients with history of alcohol use,Discontinuation of drug due to other adverse effects except hepatotoxicity ,Inadequate date of laboratory testing at baseline or 2 to 4 weeks after treatment initiation, Cases with human immunodeficiency virus (HIV) co-infection, viral hepatitis, or suspected mal absorption (e.g., gastrointestinal disease or diarrhea) ,Chronic liver disease, COPD, asthma, myocardial infarction, chronic kidney disease and stroke will be excluded",[74,75],"Drug Induced Liver Injury","Tuberculosis (TB)",[77],"prevention of Antituberculous drugs induced liver injury","NOT_YET_RECRUITING","2025-07-04",{"date":81,"type":82},"2025-07-10","ACTUAL",{"date":84,"type":68},"2025-07",{"date":86,"type":68},"2026-05",{"name":5,"class":6}]