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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAmr kamel khalil Ahmed

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

200 Participants
are divided into 2 treatment groups

Locations

1
Ministry of health Riyadh Saudi Arabia

Sponsors and collaborators

Amr kamel khalil Ahmed

Lead sponsor

Ministry of Health, Saudi Arabia

Sponsor institution

Ministry of Health, Saudi Arabia

Collaborator