NCT01087359已完成4 期
Antiinflammatoric and Antioxidative Effect of Melatonin in Human Endotoxaemia
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
- 12
- 试验地点
- 1
- 主要终点
- Inflammatoric markers
研究概览
简要总结
This is a double blinded, randomised, crossover study with 12 healthy men between 18 and 40 year. The design is based on 6 days:
- day 1: On day time administration of LPS.
- day 2: On night time administration of LPS.
- day 3: On day time administration of LPS + Placebo.
- day 4: On day time administration of LPS + melatonin.
- day 5: On night time administration of LPS + placebo.
- day 6: On night time administration og LPS + melatonin.
Measuring the inflammatoric and oxidative response of LPS and the effect of melatonin compared to placebo on the endotoxaemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age 18-49 year.
- •No sleepiness disorders.
- •No medication
排除标准
- •Allergia to melatonin
- •Alcohol abuse.
研究组 & 干预措施
LPS day
Experimental
干预措施: Melatonin (Drug)
LPS + melatonin night
Active Comparator
干预措施: Melatonin (Drug)
LPS + placebo night
Placebo Comparator
干预措施: Melatonin (Drug)
LPS + melatonin day
Active Comparator
干预措施: Melatonin (Drug)
LPS + placebo day
Placebo Comparator
干预措施: Melatonin (Drug)
LPS night
Experimental
干预措施: Melatonin (Drug)
结局指标
主要结局
Inflammatoric markers
时间窗: measured before and after the administration of LPS endotoxin.
IL-6 TNF-alpha YKL-40
Oxidative markers
时间窗: measured before and after the administration of LPS endotoxin.
Vit C MDA (malondialdehyde)
次要结局
- Secondary outcome(constant measurment)
研究者
研究点 (1)
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