About this trial
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.
Eligibility criteria
Qualifiers
Diabetic pilgrims attending Hajj.
Age between 18 and 80 years.
Willingness to participate and provide informed consent.
Diagnosis of Type 1 or Type 2 Diabetes Mellitus.
Disqualifiers
Patients with severe renal failure.
Patients with acute cardiovascular events.
Patients unable to take oral fluids.
Pregnancy or breastfeeding.
Trial design
Treatments tested in this trial
- Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS)
- Standard Oral Rehydration Salts (ORS)
Treatment groups
Sponsors and collaborators
Amr kamel khalil Ahmed
Lead sponsor
Ministry of Health, Saudi Arabia
Sponsor institution
Ministry of Health, Saudi Arabia
Collaborator