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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Modified Oral Rehydration Salts (ORS)( Amr and khulood ORS)
Other interventionModified 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 interventionStandard World Health Organization (WHO) ORS formula used as an active comparator.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Modified ORS GroupExperimental treatment 1 intervention
Group B: Standard ORS GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in serum sodium levels from baseline to post-treatment
Assessment of electrolyte balance by measuring the change in serum sodium levels (mmol/L) after the administration of ORS.
Time frame
Baseline and 24 hours post-treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Amr kamel khalil Ahmed
Lead sponsor
Ministry of Health, Saudi Arabia
Sponsor institution
Ministry of Health, Saudi Arabia
Collaborator
Source ClinicalTrials.gov
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