[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586752":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":25,"locations":35,"responsibleParty":72,"collaborators":76,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":24,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":38,"whyStopped":24,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Prednisolone dose of 40mg\u002Fday for 7 days","ACTIVE_COMPARATOR","Participants satisfying the inclusion criteria will be randomly allocated. Participants in Group A will receive prednisolone dose of 40 mg\u002Fday for 7 days after which the participants will recieve seven days of prednisolone 40 mg\u002Fday for next 7 days provided they had responded on day 7 based on Lille score",[13],"Drug: Prednisolone 40 mg",{"label":15,"type":10,"description":16,"interventionNames":17},"Prednisolone dose of 40mg\u002Fday for 14 days","Participants satisfying the inclusion criteria will be randomly allocated. Participants in Group B will receive prednisolone dose of 40 mg\u002Fday for 14 days only if they respond to on day 7 based on Lille score",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","Prednisolone 40 mg","Patients will be screened for infection till 90 days from the day of initiation of prednisolone. the three patient arms will be compared for severity scores of the disease, rate and severity of infections, diabetic control, post-treatment outcomes, and mortality.",[15,9],null,[26,32],{"name":27,"role":28,"phone":29,"phoneExt":30,"email":31},"ANAND KULKARNI V DR. ANAND V KULKARNI, SENIOR CONSULTANT","CONTACT","04042444222","1428","anandvk90@gmail.com",{"name":33,"role":28,"phone":29,"phoneExt":24,"email":34},"Sridevi prasanna daparti, DR","deviprasanna9804@gmail.com",[36,64],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"AIG Hospitals","RECRUITING","Hyderabad","Telangana","500032","India","IN",{"type":45,"coordinates":46},"Point",[47,48],78.45636,17.38405,{"lat":48,"lon":47},[51,53,55,58,60,62],{"name":52,"role":28,"phone":29,"phoneExt":30,"email":31},"Anand v kulkarni Dr, SENIOR CONSULTANT",{"name":54,"role":28,"phone":29,"phoneExt":24,"email":34},"Sridevi prasanna Daparti, Dr",{"name":56,"role":57,"phone":24,"phoneExt":24,"email":24},"Madhumita PREMKUMAR Dr, MD, DM","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":24,"phoneExt":24,"email":24},"karan kumar Dr, MD, DM",{"name":61,"role":57,"phone":24,"phoneExt":24,"email":24},"Akash Roy DR, MD, DM",{"name":63,"role":57,"phone":24,"phoneExt":24,"email":24},"suprabhat giri DR, MD, DM",{"facility":65,"status":38,"city":39,"state":40,"zip":66,"country":42,"countryCode":43,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"AIG","500035",{"type":45,"coordinates":68},[47,48],{"lat":48,"lon":47},[71],{"name":52,"role":28,"phone":24,"phoneExt":24,"email":24},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Anand Kulkarni","Dr",[77,79,81,84],{"name":78,"class":6},"Mahatma Gandhi Medical College",{"name":80,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"name":82,"class":83},"Kalinga Institute of Medical Sciences, Bhubaneswar","UNKNOWN",{"name":85,"class":6},"Apollo Gleneagles Hospitals, Kolkata","100586752","phase-3-short-course-steroids-in-alcohol-associated-hepatitis-100586752",false,"NCT06919458","Short Course Steroids in Alcohol Associated Hepatitis","Seven Day Versus Fourteen-day Corticosteroid in Patients With Severe Alcohol -Associated Hepatitis- A Double Blind Randomized Controlled Trail (STASH II)","STASHII","Inclusion Criteria:\n\n* Patients with AAH aged between 18 and 80 years with a MELD score \\>21 and\u002For mDF \\>32 will be included.\n* Patients with infection at baseline will be included if they have controlled infection defined as afebrile for at least 48 hours, sterile cultures and procalcitonin \\\u003C 1 ng\u002Fml.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years, \\> 80 years\n* Active Infection\n* Persistent acute kidney injury (creatinine \\>1.5 mg\u002Fdl) or chronic kidney disease\n* Recent\u002Fongoing bleed\n* Active peptic ulcer disease\n* Hepatocellular carcinoma, portal vein thrombosis or hepatic venous outflow tract obstruction\n* Patients with concomitant other liver diseases including hepatitis B, C\n* Patients with HIV\n* Uncontrolled diabetes mellitus\n* Patients on pentoxifylline or NAC\n* Patients who are unwilling","ALL","18 Years","80 Years",{"count":98,"type":99},146,"ESTIMATED","INTERVENTIONAL",[102],"PHASE3","Alcohol-associated hepatitis (AAH) is one of the most severe manifestations of the spectrum of alcohol related liver disease (ARLD), with high morbidity and mortality. Currently, corticosteroids are the standard of care for patients with severe AAH, but no consensus exists on the dosing schedule of steroids. The investigators have recently demonstrated that tapering prednisolone over 4 weeks reduces the risk of infections at day 90. However, the investigators wanted to test whether the reduction in the duration of therapy would provide a similar benefit as tapering the dose of prednisolone. Therefore, the investigators planned to assess the impact of a shorter duration of prednisolone on outcomes, including the incidence of infections, survival and adverse events. One group will receive 7 days of prednisolone followed by a placebo for the next seven days, and the other group will receive 40 mg of prednisolone for 14 days. Prednisolone will be stopped in case of non-response and\u002For adverse events to the drug. All infections will be diagnosed by an ID specialist who is blind to the allocated group.",[105],"Alcoholic Hepatitis",[107,108,109],"STASH II","corticosteroids","infections","2025-04-15",{"date":112,"type":113},"2025-04-17","ACTUAL",{"date":115,"type":113},"2025-04-07",{"date":117,"type":99},"2026-04-08",{"name":5,"class":6},2]