[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100412732":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":23,"centralContacts":28,"locations":33,"responsibleParty":53,"collaborators":18,"id":56,"slug":57,"hasResults":58,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":58,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":18,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":87,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Asian Institute of Gastroenterology, India","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Personalised education","EXPERIMENTAL","1. Greetings.\n2. Recording of demographic, clinical (disease related), nutritional, laboratory, and treatment related data.\n3. Administration of questionnaires.\n4. Inquiring patient's perception of their disease.\n5. Explaining the patient about their disease in general followed by specific aspects and possible outcomes in the context of their perception, clinical aspects, questionnaire, and imaging data. In addition, the general treatment plan will be explained.\n6. Address all queries from the patient and care givers.",[13],"Other: Personalised education",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard communication","NO_INTERVENTION","1. Greetings.\n2. Recording of demographic, clinical (disease related), nutritional, laboratory, imaging and treatment related data.\n3. Administration of questionnaires.\n4. Explaining the general treatment plan.\n5. Address general treatment related queries from the patient and care givers.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":18},"Patients will be explained about their disease and possible outcomes based on clinical, biochemical and imaging data.",[9],[24],{"name":25,"affiliation":26,"role":27},"Rupjyoti Talukdar, MD, FICP, AGAF","Asian Institute of Gastroenterology","PRINCIPAL_INVESTIGATOR",[29],{"name":25,"role":30,"phone":31,"phoneExt":18,"email":32},"CONTACT","7032804231","rup_talukdar@yahoo.com",[34],{"facility":26,"status":18,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Hyderabad","Telangana","500032","India","IN",{"type":41,"coordinates":42},"Point",[43,44],78.45636,17.38405,{"lat":44,"lon":43},[47,50],{"name":48,"role":30,"phone":49,"phoneExt":18,"email":32},"Rupjyoti Talukdar, MD, FICP, AGAF, FRCP, FRSB","+917032804231",{"name":51,"role":30,"phone":18,"phoneExt":18,"email":52},"Shagufta Farheen, Pharm D","shagufta12farheen@gmail.com",{"type":27,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Rupjyoti Talukdar","Director, Pancreatology; Head, Pancreas Research Group and Division of Gut Microbiome Research","100412732","personalized-education-and-pain-response-in-chronic-pancreatitis-100412732",false,"NCT04654377","Personalized Education and Pain Response in Chronic Pancreatitis","Impact of Personalized Education on Pain Response in Patients With Chronic Pancreatitis (PEPCP)","PEPCP","Inclusion Criteria:\n\n* Chronic pancreatitis of at least 3 years\n* At least 3 episodes of pain in the past 3 months\n* Age 18-60yrs\n* Both genders\n\nExclusion Criteria:\n\n* Acute pancreatitis episode at the time of enrolment.\n* Pancreatic cancer.\n* Other chronic diseases (including end organ damage related to diabetes).\n* Adverse life event in the family in the past 6 months.\n* Active substance use (alcohol, smoking, smokeless tobacco, Illicit drugs).\n* Pregnancy and lactation.\n* Psychiatric illness at enrolment or during follow-up, and\u002For concomitant intake of antidepressants and neuromodulators..","ALL","18 Years","60 Years",{"count":68,"type":69},114,"ESTIMATED","INTERVENTIONAL",[72],"NA","Pain mechanisms in chronic pancreatitis (CP) are heterogeneous and includes nociception, pancreatic neuropathy and central neuropathy\u002Fneuroplasty. These mechanisms could occur simultaneously in variable proportions and could explain why several patients develop recurrence of pain even after being treated by all the currently available modalities, such as antioxidants, endoscopic therapies and surgery.\n\nIn the studies by the investigators over the past 2 years, they observed that persistent pain in these patients was associated with varying grades of depression and poor quality of life. This was accompanied by alteration in the metabolites in the brain (anterior cingulate cortex, prefrontal cortex, hippocampus, and basal ganglia) as evidenced in magnetic resonance spectroscopy (MRS) of the brain. These areas in the brain are responsible for pain modulation, long-term pain memory and emotional responses to pain.\n\nWhen the investigators counselled these patients and explained their disease and possible outcomes based on their own clinical course, imaging and treatment response (personalized education\u002Fcounselling), they reported significant improvement in depression, quality of life parameters and, interestingly, also in pain. Further, there were changes in the metabolite parameters in the brain on MRS after personalized counselling\u002Feducation that was more similar to that of healthy controls.\n\nThis led to our hypothesis that better understanding of the disease and its outcomes by the patients could improve their coping capabilities and increase their pain thresholds. This could augment the pain responses of these patients to the other therapeutic modalities.\n\nWe will conduct this single blinded, placebo controlled, randomized controlled trial on patients with documented CP of over 3 years duration, who had at least 3 episodes of abdominal pain of over the past 3 months.",[75,76,77],"Chronic Pancreatitis","Pain Syndrome","Depression, Anxiety",[79,80,81,82,83,84,85,86],"chronic pancreatitis","pain","depression","anxiety","quality of life","metabolome","magnetic resonance spectroscopy","quantitative sensory testing","NOT_YET_RECRUITING","2025-07-27",{"date":90,"type":91},"2025-07-30","ACTUAL",{"date":93,"type":69},"2025-08-01",{"date":95,"type":69},"2026-12-31",{"name":5,"class":6},1]