NCT02470117已完成4 期
Comparison of the Efficacy of Alginate-based Reflux Suppressant and Magnesium-aluminium Antacid Gel for Treatment of Heartburn in Pregnancy : A Randomized Double-Blind Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Frequency of heartburn as measured by diary chart
研究概览
简要总结
This study evaluates the efficacy of alginate-based reflux suppressant and magnesium-aluminium antacid gel for treatment of heartburn in pregnancy. Half of the participants will receive alginate-based reflux suppressant, while the other half will receive magnesium-aluminium antacid gel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women gestational age less than 36 weeks with heartburn
排除标准
- •Having medical disease that contraindicated to use study drug
- •Allergic to alginate-based reflux suppressant and magnesium-aluminium antacid gel
研究组 & 干预措施
Alginate-based reflux suppressant
Active Comparator
Alginate-based reflux suppressant 15 ml oral every 6 hours for 2 weeks
干预措施: Alginate-based reflux suppressant (Drug)
magnesium-aluminium antacid gel
Sham Comparator
magnesium-aluminium antacid gel 15 ml oral every 6 hours for 2 weeks
干预措施: magnesium-aluminium antacid gel (Drug)
结局指标
主要结局
Frequency of heartburn as measured by diary chart
时间窗: 2 weeks
次要结局
- Intensity of hearburn as measured by visual analog scale(2 weeks)
- quality of life as measured by questionnaire SF-8(2 weeks)
- satisfaction as measured by questionnaire(2 weeks)
- Number of participants with side effects(2 weeks)
- fetal outcomes as measured by birth weight and Apgar scores(at birth)
研究者
Vorapong Phupong
Prof. Vorapong Phupong
Chulalongkorn University
研究点 (1)
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