NCT05621590已完成早期 1 期
MLC901 in Hypoxic-ischemic Brain Injury Patients; A Double-blind, Randomized Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- neurofunctional outcome using Glasgow Outcome Scale (GOS)
研究概览
简要总结
In a randomized, placebo-controlled trial, 35 patients with HIBI were randomly designated to receive either MLC901 or placebo capsules over six months.
We evaluated patients in two groups by modified Rankin Scale (mRS) and Glasgow outcome scale (GOS) to examine their state of disability and recovery
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •an initial cardiac arrest leading to coma, successful return of spontaneous circulation, and persistent coma after the return of spontaneous circulation.
排除标准
- •pregnancy, cardiogenic shock (systolic blood pressure less than 90 mm Hg despite epinephrine infusion), possible causes of coma other than cardiac arrest (drug overdose, head trauma, or cerebrovascular accident), an underlying background of known acute or chronic disease including renal failure, liver or pulmonary disorders, previous stroke, dementia, and brain injury.
研究组 & 干预措施
mlc-901 group
Experimental
干预措施: MLC 901 (Drug)
placebo group
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
neurofunctional outcome using Glasgow Outcome Scale (GOS)
时间窗: 6 months
neurofunctional outcome using modified Rankin Scale (mRS)
时间窗: 6 months
次要结局
未报告次要终点
研究者
Ali Amini Harandi
associate professor
Shahid Beheshti University of Medical Sciences
研究点 (1)
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