Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-Blind, Placebo-Controlled, Phase 3, Multicenter Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- the modified Rankin scale
研究概览
简要总结
The purpose of this phase 3 study is to validate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.
详细描述
A phase Ⅲ randomized, double-blind, placebo-controlled, multicenter study was conducted to examine the efficacy and safety of ginsenoside-Rd in patients with acute ischemic stroke. Stroke patients were randomized equally to receive a 14-day infusion of placebo or ginsenoside-Rd 20mg. Primary end points were NIHSS scores at 15 days. Secondary end points were NIHSS scores and the Barthel index at 8 days, the Barthel index and the modified Rankin scale at 15 days and 90 days. The safety end points included serious and nonserious adverse events, laboratory values and vital signs. Analysis was by intention to treat.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 to 75 years
- •the first episode
- •from onset to admission within 72 hours
- •NIHSS scores:5~22
排除标准
- •had other intracranial pathologies (e.g., tumor, infection)
- •had a neurologic or psychiatric disease
- •had a coexisting condition that limited their life expectancy
- •had significant drug or alcohol misuse
- •had high-grade carotid artery stenosis for which surgery was planned
- •were pregnant or nursing
- •participated in a clinical trial with an investigational drug or device within the past 3 months
- •were unlikely to be available for follow-up
研究组 & 干预措施
ginsenoside-Rd 20mg
infusion of ginsenoside-Rd 20mg once a day and continued for 14 days
干预措施: ginsenoside-Rd (Drug)
placebo
infusion placebo (group B)once a day and continued for 14 days
干预措施: placebo (Drug)
结局指标
主要结局
the modified Rankin scale
时间窗: 90 days
次要结局
- NIHSS scores(15 days)
- the Barthel index(15 days)
- the modified Rankin scale(15 days)