Efficacy and Safety of Ginsenoside-Rd for Acute Ischemic Stroke: A Randomized, Double-blind, Placebo-controlled, Phase Ⅱ, Multicenter Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 199
- 试验地点
- 1
- 主要终点
- NIHSS scores
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of ginsenoside-Rd for acute ischemic stroke.
详细描述
A major contributor to brain injury after stroke is disordered inward flow of Ca2+ and its toxic accumulation in the nervous system following cerebral ischemia. Ginsenoside-Rd, a purified component from total saponins of Panax notoginseng, has a molecular formula of C48H82O18•3H2O with a molecular weight of 1001.2. Ginsenoside-Rd has been shown to inhibit receptor-operated Ca2+ influx through receptor-and-store-operated Ca2+ channels (ROCC) , attenuate oxidative stress in stroke, reduce the size of the cerebral infarction and preserve brain functioning in animal models of acute ischemic stroke.
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 10mg
both a ginsenoside-Rd injection (10mg/1ml/each) and a specific dilution (10%, 1ml trimethylene glycol) were respectively diluted by a specific dilution (10%, 9 ml trimethylene glycol) and then mixed.
干预措施: ginsenoside-Rd 10 mg (Drug)
placebo
2 specific dilutions (10%, 1ml trimethylene glycol) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed.
干预措施: placebo (Drug)
ginsenoside-Rd 20mg
2 ginsenoside-Rd injections (10mg/1ml/each) were respectively diluted by 2 specific dilutions (10%, 9 ml trimethylene glycol) and then mixed
干预措施: ginsenoside-Rd 20mg (Drug)
结局指标
主要结局
NIHSS scores
时间窗: 15±1 days
次要结局
- NIHSS scores(8 days)
- the Barthel index(15 days)
- the modified Rankin scale(90 days)