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Efficacy and Safety of Modified ORS(Amr and Khulood ORS) in Diabetic Pilgrims During Hajj
Sponsor: Amr kamel khalil Ahmed
Summary
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2026-06
Completion Date
2027-06
Last Updated
2026-06-01
Healthy Volunteers
No
Conditions
Interventions
Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS)
Modified ORS formula ( Amr and khulood ORS) with adjusted electrolyte and carbohydrate content suitable for diabetic patients to prevent heat-related dehydration.
Standard Oral Rehydration Salts (ORS)
Standard World Health Organization (WHO) ORS formula used as an active comparator.
Locations (1)
Ministry of health
Riyadh, Saudi Arabia