[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649690":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":43,"responsibleParty":79,"collaborators":26,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":88,"eligibilityCriteria":89,"healthyVolunteers":84,"sex":90,"minAge":91,"maxAge":26,"enrollmentInfo":92,"targetDuration":26,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":101,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Mahidol University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Melatonin","EXPERIMENTAL","Participants were randomized into two groups to receive either 2 mg of prolonged release melatonin or placebo, which were manufactured to be identical in appearance. The study medication was prescribed at a dose of one tablet daily, taken one hour before the participant's usual bedtime. Participants were scheduled for follow-up at 6 and 12 weeks after initiation of the study medication, either at the IBD clinic or via telephone contact. At the 6-week follow-up, sleep quality was assessed using PSQI. If the PSQI score decreased from baseline, participants continued the study medication at the same dose until the end of the study. If the PSQI score remained unchanged or increased, the dose of the study medication was escalated to two tablets per day and continued at that dose until study completion.",[13],"Drug: Melatonin (\"Circadin\")",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","placebo were manufactured to be identical in appearance",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Melatonin (\"Circadin\")","2 mg of prolonged release melatonin was prescribed at a dose of one tablet daily, taken one hour before the participant's usual bedtime.",[9],null,{"type":22,"name":15,"description":17,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"affiliation":32,"role":33},"Julajak Limsrivilai, MD","Faculty of Medicine Siriraj Hospital, Mahisol University","PRINCIPAL_INVESTIGATOR",[35,39],{"name":31,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","+66814968895","alimsrivilai@gmail.com",{"name":40,"role":36,"phone":41,"phoneExt":26,"email":42},"Ekawat Manomaiwong, MD","+66876818221","e_manomaiwong@hotmail.com",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Division of Gastroenterology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University 2 Wang Lang Rd","RECRUITING","Bangkok Noi","Bangkok","10700","Thailand","TH",{"type":53,"coordinates":54},"Point",[55,56],100.47798,13.76266,{"lat":56,"lon":55},[59,62,64,65,67,69,71,73,75,77],{"name":60,"role":36,"phone":41,"phoneExt":26,"email":61},"ekawat manomaiwong, MD","e.manomaiwong@gmail.com",{"name":63,"role":36,"phone":37,"phoneExt":26,"email":38},"Julajak Limsrivilai, MD, MSc",{"name":31,"role":33,"phone":26,"phoneExt":26,"email":26},{"name":40,"role":66,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":68,"role":66,"phone":26,"phoneExt":26,"email":26},"Onuma Sattayalertyanyong, MD",{"name":70,"role":66,"phone":26,"phoneExt":26,"email":26},"Thanaboon Chaemsupaphan, MD",{"name":72,"role":66,"phone":26,"phoneExt":26,"email":26},"Chawanont Pimolsri, MD",{"name":74,"role":66,"phone":26,"phoneExt":26,"email":26},"Wattanachai Chotinaiwattarakul, MD",{"name":76,"role":66,"phone":26,"phoneExt":26,"email":26},"Kamonnet Wannasewok, MD",{"name":78,"role":66,"phone":26,"phoneExt":26,"email":26},"Marianee Salaemae",{"type":33,"investigatorFullName":80,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Julajak Limsrivilai","Associate Professor Julajak Limsrivilai, M.D.","100649690","phase-4-efficacy-of-melatonin-treatment-on-sleep-quality-improvement-in-inflammatory-bowel-disease-patients-with-clinical-remission-100649690",false,"NCT07737665","Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission","Efficacy of Melatonin Treatment on Sleep Quality Improvement in Inflammatory Bowel Disease Patients With Clinical Remission: A Randomized Double-Blind Placebo-Controlled Trial","Melatonin IBD","Inclusion Criteria:\n\n* IBD patients with clinical remission Crohn's disease: HBI \\\u003C 5 Ulcerative colitis: Partial Mayo score 0-1 w\u002Fo bloody stool\n* Age \\> 18 years\n* PSQI score \\> 5\n* No medical adjustment for 2 months and use corticosteroids not more than Prednisolone equivalent 5 mg\u002Fday\n\nExclusion Criteria:\n\n* Current alcohol or substance abuse\n* High risk for OSA (STOP-BANG score \\> 5)\n* Psychiatric problem: PHQ-9 score \\> 20 or GAD-7 score \\> 20\n* Hypnotic drug use and unable to hold for 1week before trial\n* Shift worker","ALL","18 Years",{"count":93,"type":94},90,"ESTIMATED","INTERVENTIONAL",[97],"PHASE4","Sleep disturbances are common in patients with inflammatory bowel disease (IBD) and are associated with increased disease activity and reduced quality of life. Melatonin, a hormone regulating circadian rhythms, has shown potential anti-inflammatory and sleep-promoting effects in preliminary studies. This study aimed to evaluate the efficacy of melatonin supplementation on sleep quality in IBD patients in clinical remission.",[100],"IBD (Inflammatory Bowel Disease)",[102,103,104,105,106,107],"inflammatory bowel disease","melatonin","sleep quality","Pittsburgh Sleep Quality Index","quality of life","fecal calprotectin","2026-08-01",{"date":110,"type":111},"2026-08-04","ACTUAL",{"date":113,"type":111},"2025-04-01",{"date":115,"type":94},"2027-04-30",{"name":5,"class":6},1]