[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648439":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":34,"responsibleParty":51,"collaborators":18,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":57,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":18,"studyType":69,"phases":70,"briefSummary":73,"conditions":74,"keywords":77,"overallStatus":82,"whyStopped":18,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Melatonin group","EXPERIMENTAL","32 patients will receive the standard of care treatment in addition to melatonin oral drug (15 mg\u002Fday) once daily for 12 weeks taken 30 minutes to 1 hour before bedtime.",[13],"Drug: Melatonin",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group:","NO_INTERVENTION","32 patients will receive standard of care",null,[20],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":18},"DRUG","Melatonin",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Nirmeen A. Habib, Master","CONTACT","+201124147642","nirmeen.ms2324020@pharma.asu.edu.eg",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Areej M. Ateya, lecturer","+201003152806","areeg.mohamed@pharma.asu.edu.eg",[35],{"facility":36,"status":18,"city":37,"state":18,"zip":18,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Department of Rheumatology Ain Shams University hospitals","Cairo","Egypt","EG",{"type":41,"coordinates":42},"Point",[43,44],31.24967,30.06263,{"lat":44,"lon":43},[47,49],{"name":48,"role":27,"phone":28,"phoneExt":18,"email":29},"Nirmeen Amr Habib Nirmeen Amr",{"name":50,"role":27,"phone":32,"phoneExt":18,"email":33},"Areej Mohamed Atya Lecturer, PhD",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","nirmeen amr habib","Nirmeen Amr","100648439","phase-2-effect-of-melatonin-administration-on-systemic-lupus-erythematosus-patients-100648439",false,"NCT07721324","Effect of Melatonin Administration on Systemic Lupus Erythematosus Patients","Effect of Melatonin Administration on the Clinical Outcomes of Systemic Lupus Erythematosus Patients","SLE","Inclusion Criteria:\n\n* Adult male and female patients with active SLE aged 18-60 years\n* Active SLE patients defined on SLEDAI-2K score to be (more than or equal 4 up to 11) according to the classification of SLE as suggested by the American Rheumatology Association (American College of Rheumatology)\n* Have had non-life-threatening disease\n* Taking stable doses of medications for SLE treatment in the last three months\n* Ability and willingness to cooperate in the study\n\nExclusion Criteria:\n\n* Other autoimmune diseases\n* Uncontrolled hypertension or Uncontrolled DM\n* Severe renal (GFR \\\u003C 30 ml\u002Fmin ) or severe liver diseases (ALT or AST \\\u003C3 times ULN or total bilirubin \\> 2 times ULN)\n* Life-threatening SLE including\n\n  * Severe hemolysis (reticulocyte count \\>8%)\n  * Severe thrombocytopenia (platelet count \\\u003C40 000)\n  * Endocarditis\n  * Lupus pneumonia\n  * Alveolar hemorrhage\n* Using sedations, antidepressants, contraceptives, antioxidant and\u002For omega-3-fatty acid supplements one month prior to or during the study\n* Smoking and\u002F or alcohol intake\n* Allergy to melatonin\n* Pregnancy, pregnancy plans and lactation.\n* Having active infectious diseases\n* poor patient compliance\n* Any sleeping pills two weeks prior to the study\n* Malabsorption syndromes\n* Malignancy\n* Warfarin or heparin use or high-dose aspirin (more than 325 mg\u002Fday)\n* Stroke","ALL","18 Years","60 Years",{"count":67,"type":68},64,"ESTIMATED","INTERVENTIONAL",[71,72],"PHASE2","PHASE3","The aim of the current study is to evaluate the effect of melatonin administration on circulating levels of inflammatory mediators, oxidative stress, sleep quality, fatigue and quality of life in patients with SLE. To the best of our knowledge, this is the first randomized-controlled trial to evaluate the impact of melatonin on sleep quality and assess fatigue and quality of life in SLE adult patients. Moreover, the impact of melatonin on serum concentrations of Interleukin-6 and superoxide dismutase SOD will be evaluated.",[75,76],"Therapy","Treatment",[22,78,79,80,81],"Systemic Lupus Erythematosus","Inflammation","Fatigue","SLEQoL","NOT_YET_RECRUITING","2026-07-18",{"date":85,"type":86},"2026-07-23","ACTUAL",{"date":88,"type":68},"2026-07-21",{"date":90,"type":68},"2026-11-21",{"name":5,"class":6},1]