NCT02809027已完成4 期
A Randomized Double-blind Placebo-controlled Trial on the Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient
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
- 178
- 主要终点
- incidence abdominal distention as measured by diary chart (history taking and examination)
研究概览
简要总结
The purpose of this study is to determine ginger is effective in the prevention of abdominal distention in post Cesarean section patient.
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
- 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
- •Post cesarean section women
排除标准
- •allergic to ginger
- •time of cesarean section more than 1 hour
- •perform another operation such as appendectomy, cystectomy
- •former use carminative drugs
- •already have abdominal distention
研究组 & 干预措施
Ginger
Active Comparator
Ginger capsule (500 mg), oral form, 2 capsules 3 time after meal for 3 days
干预措施: Ginger (Drug)
Placebo
Sham Comparator
Placebo capsule, oral form, 2 capsules 3 time after meal for 3 days
干预措施: Placebo (Drug)
结局指标
主要结局
incidence abdominal distention as measured by diary chart (history taking and examination)
时间窗: 72 hours
次要结局
- Quality of life as measured by questionaire(72 hours)
- Maternal satisfaction as measured by questionaire(72 hours)
- nausea vomiting as measured by questionaire(72 hours)
- first time to pass flatus/feces as measured by diary chart(72 hours)
- number of carminative drug use as measured by questionaire(72 hours)
- side effect as measured by questionaire(72 hours)
研究者
Vorapong Phupong
Professor Vorapong Phupong
Chulalongkorn University
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终止
3 期
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