[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100626914":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":101,"collaborators":11,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":11,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":44,"whyStopped":11,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":139},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Enteric coated enzyme preparation containing: Lipase 25000U, Amylase 18000U, Protease 1000U. These m","EXPERIMENTAL",null,[13],"Drug: Pancreatic enzyme capsules",{"label":15,"type":16,"description":17,"interventionNames":18},"Similar appearing glucose capsules will be provided three times a day along with food","PLACEBO_COMPARATOR","Drug: Placebo Similar appearing glucose capsules",[19],"Drug: Placebo",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","Pancreatic enzyme capsules","Enteric coated pancreatic enzyme",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Placebo","Similar appearing glucose capsules",[15],[31],{"name":32,"affiliation":33,"role":34},"Rupjyoti Talukdar, MD","Asian Institute of Gastroenterology Hospitals","STUDY_DIRECTOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":11,"email":40},"Abdul Rasheed, PharmD","CONTACT","+919652104726","abdulrasheedmd1223@gmail.com",[42,61,75,86],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Gauhati Medical College","RECRUITING","Guwahati","Assam","781032","India","IN",{"type":51,"coordinates":52},"Point",[53,54],91.7458,26.1844,{"lat":54,"lon":53},[57],{"name":58,"role":38,"phone":59,"phoneExt":11,"email":60},"Mallika Bhattacharyya, MD","+918135848141","mallikabhattacharyya@gmail.com",{"facility":62,"status":44,"city":63,"state":64,"zip":65,"country":48,"countryCode":49,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"Asian Institute of Gastroenterology Hospitals, Gachibowli","Hyderabad","Telangana","500032",{"type":51,"coordinates":67},[68,69],78.45636,17.38405,{"lat":69,"lon":68},[72],{"name":32,"role":38,"phone":73,"phoneExt":11,"email":74},"+917032804231","rup_talukdar@yahoo.com",{"facility":76,"status":44,"city":63,"state":64,"zip":77,"country":48,"countryCode":49,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Asian Institute of Gastroenterology, Banjara Hills","500082",{"type":51,"coordinates":79},[68,69],{"lat":69,"lon":68},[82],{"name":83,"role":38,"phone":84,"phoneExt":11,"email":85},"Jahangeer Basha, DM","9000199577","dr.jahangeer@aighospitals.com",{"facility":87,"status":44,"city":88,"state":89,"zip":90,"country":48,"countryCode":49,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"ILS Hospital, Dum Dum","Kolkata","West Bengal","700080",{"type":51,"coordinates":92},[93,94],88.36304,22.56263,{"lat":94,"lon":93},[97],{"name":98,"role":38,"phone":99,"phoneExt":11,"email":100},"Sanjay Banerjee, DM","+919830129866","drsanjaygastro@gmail.com",{"type":102,"investigatorFullName":103,"investigatorTitle":104,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Rupjyoti Talukdar","Director, Pancreatology, AIG Hospitals","100626914","phase-3-pancreatic-enzyme-replacement-in-acute-necrotizing-pancreatitis-100626914",false,"NCT07441824","Pancreatic Enzyme Replacement in Acute Necrotizing Pancreatitis","Effect of Pancreatic Enzyme Replacement Therapy in Patients With Acute Necrotizing Pancreatitis: A Multicenter Double Blinded Randomised Placebo Controlled Trial","PERiANP","Inclusion Criteria:\n\n* Patients diagnosed with AP according to the Revised Atlanta Classification diagnostic criteria\n* Index episode of acute pancreatitis with more than 50% pancreatic parenchymal necrosis and at least 5% loss of pre pancreatitis body weight at the time of screening\n* Within 6 weeks of onset of disease\n* Able to take food orally\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":117,"type":118},140,"ESTIMATED","INTERVENTIONAL",[121],"PHASE3","In this multicenter, double blinded, placebo-controlled, 1:1 parallel group RCT, the investigators propose to evaluate the impact of pancreatic exocrine replacement therapy on patients with acute necrotizing pancreatitis (ANP). The investigators will include patients of 18-60yrs age and both genders with \\>50% pancreatic parenchymal necrosis and at least 5% loss of body weight.\n\nThe primary outcome measure is percent change in body weight at 3 months after enrolment. The intervention will include pancreatic enzyme consisting of 25000 IU of lipase and similar appearing placebo.",[124,125],"Acute Necrotizing Pancreatitis","Pancreatic Exocrine Insufficiency",[127,128,129],"acute pancreatitis","pancrearic exocrine insufficiency","pancreatic enzyme replacement therapy","2026-04-29",{"date":132,"type":133},"2026-05-05","ACTUAL",{"date":135,"type":133},"2026-04-10",{"date":137,"type":118},"2027-06",{"name":5,"class":6},4]