NCT00873379已完成3 期
Melatonin Supplementation for Delirium Prevention in Acutely Hospitalized Elderly: a Randomized, Double Blind, Placebo-Controlled Trial
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- delirious using confusion assessment method (CAM)
研究概览
简要总结
122 people over 70 who were admitted to hospital were enrolled to the study. Half got .5 mg a night of melatonin, half got a placebo.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 65 admitted through the emergency department to an internal medicine service in London, Ontario, Canada.
排除标准
- •Life expectancy less than 24 hours,
- •Unable to communicate in English,
- •Unable to take oral medications,
- •Intracranial bleed or known seizure disorder,
- •Markedly sub or supra-therapeutic INR while on warfarin, OR
- •A known allergy to study tablet ingredients.
结局指标
主要结局
delirious using confusion assessment method (CAM)
时间窗: days
次要结局
- MDAS (memorial delirium assessment scale)(days)
研究者
研究点 (2)
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