Efficacy and Safety of Modified ORS(Amr and Khulood ORS) in Diabetic Pilgrims During Hajj

Starting soon · Not applicable

Conditions studied: Diabetes Mellitus, Heat Stress

In brief

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.

Key facts

Study ID

NCT07618702

Run by

Amr kamel khalil Ahmed

People needed

200

Starts

2026-06-01

Expected to finish

2027-06-01

Last updated by the study team

2026-06-01

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients with severe renal failure.
• Patients with acute cardiovascular events.
• Patients unable to take oral fluids.
• Pregnancy or breastfeeding.
• Participation in another clinical trial within the last 30 days.

Where it is running

• Ministry of health — Riyadh, Saudi Arabia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.