A Comparison of Safety and Efficacy of Dl-3-n-butylphthalide and Cerebrolysin on Neurological and Behavioral Outcomes in Acute Ischemic Stroke: a Randomized, Double-blind Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- National Institutes of Health Stroke Scale Score
研究概览
简要总结
The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12 hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a 10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were also analyzed among the three groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke within 12 hours for the first time before entry into the study
- •National Institutes of Health Stroke Scale (NIHSS) score between 6 and 25
排除标准
- •with lacunar infarction
- •with cerebral hemorrhagic infarction
- •with epilepsy or epileptic persons
- •with history of neurological diseases
- •with myocardial infarction,
- •with renal and hepatic abnormalities
- •with metabolic diseases
- •with contraindications to antiplatelet treatments
研究组 & 干预措施
Dl-3-n-butylphthalide
Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days
干预措施: Dl-3-n-butylphthalide (Drug)
Cerebrolysin
Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days
干预措施: Cerebrolysin (Drug)
Placebo
Intravenous infusion of 100 ml saline intravenous q.d. for 10 days
干预措施: Placebo (Drug)
结局指标
主要结局
National Institutes of Health Stroke Scale Score
时间窗: At 11-day and 21-day after therapy
Scores range from 0 to 42, with higher scores indicating increasing severity
次要结局
- Barthel Index Score(At 11-day and 21-day after therapy)
研究者
Hao Chen
Doctor
Shanghai 6th People's Hospital