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

Sponsor
Amr kamel khalil Ahmed
Study ID
NCT07618702
Status
Not Yet Recruiting

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Conditions

  • Diabetes Mellitus
  • Heat Stress

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS) — OTHER
    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) — OTHER
    Standard World Health Organization (WHO) ORS formula used as an active comparator.

Study Details

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 Dates

First listed
Jun 1, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Modified ORS Group
    Participants in this group will receive the modified Oral Rehydration Salts ( Amr and khulood ORS) specifically designed for diabetic patients during the Hajj season to prevent dehydration and maintain electrolyte balance.
  • Active Comparator: Standard ORS Group
    Participants in this group will receive the standard World Health Organization (WHO) Oral Rehydration Salts (ORS) formula.

Primary Outcome Measure

Change in serum sodium levels from baseline to post-treatment [ Time Frame: Baseline and 24 hours post-treatment ]

Central Contacts

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