NCT01741389已完成1 期
The Role of Melatonin in the Regulation of Blood Coagulation
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Circadian variation of hemostatic factors
研究概览
简要总结
The main aim is to examine the influence of daylight and melatonin on the temporal variations of hemostatic factors with key roles in the hemostatic process and its regulation. Particular emphasis will be on exploring the role of melatonin in hemostasis by comparing subjects with tetraplegia with able-bodied control subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Intervention group:
- •A diagnosis of tetraplegia for at least 2 years, and otherwise healthy.
- •Must not use drugs permanently (except anti-spasmolytics).
- •Must be able to swallow tablets.
- •Must give written consent to participate.
- •Control group:
- •Must be healthy.
- •Must not use drugs permanently.
- •Must give written consent to participate.
排除标准
- •Both groups:
- •Those with acute or chronic co-morbidity.
- •Unable to cooperate.
- •Not provided written consent to participate.
研究组 & 干预措施
Sleep only
Placebo Comparator
Placebo given at night to tetraplegic individuals before going to sleep,
干预措施: Melatonin ("Circadin") (Drug)
Melatonin
Active Comparator
Melatonin given at night to tetraplegic individuals before going to sleep.
干预措施: Melatonin ("Circadin") (Drug)
结局指标
主要结局
Circadian variation of hemostatic factors
时间窗: 24 hours
次要结局
未报告次要终点
研究者
Per Ole Iversen, MD
Professor
University of Oslo
研究点 (1)
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