[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609208":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":26,"responsibleParty":44,"collaborators":26,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":26,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":71,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":26},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PERT","EXPERIMENTAL","Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These medications are to be taken thrice daily with food (Breakfast, lunch and dinner)",[13],"Drug: Pancreatic Enzyme Replacement Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Similar appearing glucose capsules will be provided three times a day along with food (breakfast, lunch and dinner)",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Pancreatic Enzyme Replacement Therapy","Enteric coated pancreatic enzyme preparation",[9],null,{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":26},"Similar appearing glucose capsules",[15],[31],{"name":32,"affiliation":33,"role":34},"Rupjyoti Talukdar, MD","Asian Institute of Gastroenterology","STUDY_DIRECTOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Abdul Rasheed, PharmD","CONTACT","+919652104726","abdulrasheedmd1223@gmail.com",{"name":32,"role":38,"phone":42,"phoneExt":26,"email":43},"+917032804231","rup_talukdar@yahoo.com",{"type":45,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100609208","phase-3-pert-in-acute-necrotizing-pancreatitis-100609208",false,"NCT07211568","PERT in Acute Necrotizing Pancreatitis","Effect of Pancreatic Enzyme Replacement Therapy on Nutrition in Acute Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial.","PERT-ANP","Inclusion Criteria:\n\n* Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria\n* Index episode of acute pancreatitis with at least 50% pancreatic parenchymal necrosis and greater than at least 10% loss of pre pancreatitis body weight at the time of screening\n* Within 28 days of onset of disease\n* Age 18-60 years\n* Both genders\n\nExclusion Criteria:\n\n* Underlying chronic pancreatitis\n* Recurrent acute pancreatitis\n* Pancreatic cancer\n* Patients being discharged with NJ tubes\n* Pregnancy and lactation\n* Inability to give informed consent.","ALL","18 Years","60 Years",{"count":58,"type":59},188,"ESTIMATED","INTERVENTIONAL",[62],"PHASE3","In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, we propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). We will include patients of 18-60yrs age and both genders with \\>50% pancreatic parenchymal necrosis and \\>10% loss of body weight.\n\nThe primary outcome measure is change in BMI at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.",[65,66],"Acute Pancreatitis Necrotizing","Nutrition Assessment",[68,69,70],"Nutrition in AP","PERT in AP","pancreatic exocrine insufficiency","NOT_YET_RECRUITING","2025-09-30",{"date":74,"type":75},"2025-10-08","ACTUAL",{"date":77,"type":59},"2025-10-01",{"date":79,"type":59},"2027-07-31",{"name":5,"class":6}]