Proton Pump Inhibitors Effects on Dyspepsia During Ramadan Fasting
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Overall symptom relief during the 4 weeks of treatment
研究概览
简要总结
evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. The investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during Ramadan compared to placebo.
详细描述
evaluate the interest of proton pump inhibitors in subjects with or with GI symptoms who intend to observe fasting in Ramadan. Investigators will compare the effectiveness of proton pump inhibitors to prevent or reduce the signs of dyspepsia during at least Ramadan compared to placebo.
The study will be conducted at least from April 2019 to at least June 2030.The study is prospective, two parallel groups, randomized controlled and double blind.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Diagnosed GastroDuodenal Ulcer
研究组 & 干预措施
A : Proton Pump Inhibitors
Patients are given proton pump inhibitors tablets once a day
干预措施: Esomeprazole (Drug)
B: Placebo
Patients are given a placebo instead of proton pump inhibitors active drug
干预措施: Placebo (Drug)
结局指标
主要结局
Overall symptom relief during the 4 weeks of treatment
时间窗: 30 days after inclusion
Relief of dyspepsia symptoms during the treatment period according to the decrease of SF-LDQ score
次要结局
- number of days without dyspepsia(30 days after inclusion)
- quality of life assessment(30 days after inclusion)
- Patients satisfaction of the treatment(30 days after inclusion)
研究者
Pr. Semir Nouira
professor
University of Monastir