NCT03223350已完成2 期
Topical Capsaicin Cream for Treatment of Suspected Cyclical Vomiting Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Nausea Visual Analog Scale
研究概览
简要总结
This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the relieve of nausea and vomiting.
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)
盲法说明
Identical appearing placebo cream used for control
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suspected cyclical vomiting syndrome / cannabinoid hyperemesis
- •active severe nausea or vomiting in the emergency department
排除标准
- •pregnant women, children < 18 years, no prior history of similar symptoms, suspected surgical or infectious cause of symptoms, suspected hepatitis or pancreatitis, allergy to capsaicin or hot peppers, chronic use of prescription antiemetic in prior 24 hours, abdominal pain alone (without nausea or vomiting)
研究组 & 干预措施
Capsaicin
Experimental
0.1% capsaicin cream, one application
干预措施: Capsaicin 0.1% Cream (Drug)
Placebo
Placebo Comparator
Topical cream with no active drug
干预措施: Placebos (Drug)
结局指标
主要结局
Nausea Visual Analog Scale
时间窗: 30 minutes
Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea
次要结局
未报告次要终点
研究者
Joseph Miller, MD
Senior Staff
Henry Ford Health System
研究点 (1)
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