CTRI/2009/091/000309未知3 期
A RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE SAFETY AND EFFICACY OF EDARAVONE IN ACUTE ISCHEMIC STROKE
未提供1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 待定
试验速览
- 阶段
- 3 期
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Modified Rankin Score
研究概览
简要总结
This is a prospective, open labeled, randomized controlled clinical trial to investigate the safety and efficacy of edaravone in terms of functional outcome in patients with acute ischemic stroke, that will be conducted in the Department of Neurology, CSM Medical University, Lucknow. the primary outcome will be modified Rankin Scale at 90 days. The secondary outcome will be all cause mortality at 90 days.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
入选标准
- •Patients with acute ischemic stroke hospitalized between 6 and 72 hours of onset of stroke.
排除标准
- •Patients with age less than 18 years, unclear time of onset, those who received any thrombolytic therapy, those with severe hepatic disease, renal dysfunction, pregnancy or lactating female.
结局指标
主要结局
Modified Rankin Score
时间窗: 90 days
次要结局
- All cause mortality(90 days)
研究者
研究点 (1)
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