Efficacy and Safety of Modified ORS(Amr and Khulood ORS) in Diabetic Pilgrims During Hajj (AA-HAMS-ORS)
Efficacy and Safety of Modified Oral Rehydration Salts (ORS) in Diabetic Pilgrims With Heat Stress and Dehydration During the Hajj Mass Gathering: A Three-Arm, Active-Controlled, Randomized Clinical Trial
研究概览
地位
详细说明
Background: The Hajj pilgrimage involves strenuous physical activity in extreme heat, posing a high risk of dehydration and heat-related illnesses, particularly for diabetic patients. Standard ORS, while lifesaving, contains glucose that can exacerbate hyperglycemia.
Objective: To assess whether a modified ORS (Amr and khulood ORS) (with reduced or alternative carbohydrate sources) can safely and effectively rehydrate diabetic pilgrims.
Methods: This is a prospective, randomized, double-blind controlled trial. Participants will be diabetic pilgrims presenting with signs of mild to moderate dehydration. They will be randomized to receive either the modified ORS ( Amr and khulood ORS) or the WHO standard ORS.
Measurements: Blood glucose levels, serum electrolytes, urine specific gravity, and clinical signs of rehydration will be monitored at baseline and at regular intervals (2, 4, and 6 hours) post-intervention.
Safety: Adverse events, including severe hyperglycemia or hypoglycemia, will be recorded.
Significance: If proven effective, the modified ORS ( Amr and khulood ORS) could become a standard of care for diabetic individuals in heat-intensive environments, improving safety and health outcomes during Hajj.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：amr Central Research Office
- 电话号码：+966597310032
- 邮箱：amrka@moh.gov.sa
学习地点
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Riyadh、沙特阿拉伯
- Ministry of Health
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接触：
- Principal Investigator
- 电话号码：+966597310032
- 邮箱：drmedahmed@gmail.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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.
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Modified ORS formula ( Amr and khulood ORS) with adjusted electrolyte and carbohydrate content suitable for diabetic patients to prevent heat-related dehydration.
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有源比较器：Standard ORS Group
Participants in this group will receive the standard World Health Organization (WHO) Oral Rehydration Salts (ORS) formula.
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Standard World Health Organization (WHO) ORS formula used as an active comparator.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in serum sodium levels from baseline to post-treatment
大体时间：Baseline and 24 hours post-treatment
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Assessment of electrolyte balance by measuring the change in serum sodium levels (mmol/L) after the administration of ORS.
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Baseline and 24 hours post-treatment
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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