[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100649398":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":40,"locations":45,"responsibleParty":62,"collaborators":39,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":39,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":39,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":39,"overallStatus":85,"whyStopped":39,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Benha University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"5mg group","EXPERIMENTAL","Melatonin 5 mg and one placebo sugar tablet oral tablet, two hours preoperatively and for 14 nights postoperatively.",[13],"Drug: Melatonin 5 MG",{"label":15,"type":10,"description":16,"interventionNames":17},"10mg group","Two melatonin 5 mg oral tablet, two hours preoperatively and for 14 nights postoperatively.",[18],"Drug: Melatonin 10 MG",{"label":20,"type":21,"description":22,"interventionNames":23},"Control group","PLACEBO_COMPARATOR","Two placebo sugar tablets, two hours preoperatively and for 14 nights postoperatively.",[24],"Other: Placebo",[26,32,36],{"type":27,"name":28,"description":11,"armGroupLabels":29,"otherNames":30},"DRUG","Melatonin 5 MG",[9],[31],"Melatonin",{"type":27,"name":33,"description":16,"armGroupLabels":34,"otherNames":35},"Melatonin 10 MG",[15],[31],{"type":6,"name":37,"description":22,"armGroupLabels":38,"otherNames":39},"Placebo",[20],null,[41],{"name":42,"role":43,"phone":44,"phoneExt":39,"email":39},"Nourhan Amer, PhD","CONTACT","+20 11 11337700",[46],{"facility":47,"status":39,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Benha Univeristy","Banhā","Qalyobua","3433","Egypt","EG",{"type":54,"coordinates":55},"Point",[56,57],31.1842,30.45977,{"lat":57,"lon":56},[60],{"name":61,"role":43,"phone":44,"phoneExt":39,"email":39},"Nourhan Amer",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":39,"oldOrganization":39},"PRINCIPAL_INVESTIGATOR","Nourhan Elsayed Mohamed Amer","Principal investigator","100649398","early-phase-1-comparison-between-the-effect-of-two-different-doses-of-oral-melatonin-on-sleep-quality-after-total-hip-arthroplasty-100649398",false,"NCT07732725","Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty","Comparison Between the Effect of Two Different Doses of Oral Melatonin on Sleep Quality After Total Hip Arthroplasty A Randomized Placebo-Controlled Double-Blind Trial","Inclusion Criteria:\n\n* Elective unilateral total hip arthroplasty.\n\nExclusion Criteria:\n\n* Revision arthroplasty\n* documented sleep disorders requiring treatment,\n* use of other sleep medications preoperatively\n* known melatonin allergy or contraindication.","ALL","18 Years","80 Years",{"count":77,"type":78},150,"ESTIMATED","INTERVENTIONAL",[81],"EARLY_PHASE1","Considering the fact that melatonin was safely and effectively used in higher doses in multiple surgical conditions , the present study hypothesized that increasing melatonin dose in THA would have better benefits for patients.",[84],"Sleep Disturbance","NOT_YET_RECRUITING","2026-07-26",{"date":88,"type":89},"2026-07-29","ACTUAL",{"date":91,"type":78},"2026-08-04",{"date":93,"type":78},"2026-11-04",{"name":5,"class":6},1]