[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Amr kamel khalil Ahmed\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"100637161","efficacy-and-safety-of-modified-orsamr-and-khulood-ors-in-diabetic-pilgrims-during-hajj-100637161",false,"NCT07618702","Efficacy and Safety of Modified ORS(Amr and Khulood ORS) in Diabetic Pilgrims During Hajj","Efficacy and Safety of Modified Oral Rehydration Salts (ORS) in Diabetic Pilgrims With Heat Stress and Dehydration During the Hajj Mass Gathering: A Three-Arm, Active-Controlled, Randomized Clinical Trial","AA-HAMS-ORS","Inclusion Criteria:\n\n* Diabetic pilgrims attending Hajj.\n* Age between 18 and 80 years.\n* Willingness to participate and provide informed consent.\n* Diagnosis of Type 1 or Type 2 Diabetes Mellitus.\n\nExclusion Criteria:\n\n* Patients with severe renal failure.\n* Patients with acute cardiovascular events.\n* Patients unable to take oral fluids.\n* Pregnancy or breastfeeding.\n* Participation in another clinical trial within the last 30 days.","ALL","18 Years","80 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"NA","Heat stress and dehydration are significant risks for diabetic pilgrims during the Hajj, often leading to severe complications. Standard Oral Rehydration Salts (ORS) are effective for rehydration but may cause hyperglycemia in diabetic patients due to their glucose content. This study aims to evaluate the efficacy and safety of a modified ORS formula ( Amr and khulood ORS) , specifically designed for diabetic individuals, in maintaining hydration without adversely affecting blood glucose levels. The study will involve a randomized controlled trial comparing the modified ORS (Amr and khulood ORS) with standard ORS among diabetic pilgrims experiencing heat stress. Key outcomes include hydration status, electrolyte balance, and glycemic control.",[28,29],"Diabetes Mellitus","Heat Stress","NOT_YET_RECRUITING","2026-05-24",{"date":33,"type":34},"2026-06-01","ACTUAL",{"date":36,"type":22},"2026-06",{"date":38,"type":22},"2027-06",{"name":40,"class":41},"Amr kamel khalil Ahmed","OTHER_GOV",""]