A Double Blind, Placebo Controlled, Randomized, Multicenter Study to Investigate CHInese Medicine NeuroAid Efficacy on Stroke Recovery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,100
- 试验地点
- 24
- 主要终点
- Distribution modified Rankin Scale grades for all randomized subjects
研究概览
简要总结
CHIMES is a double blind, placebo controlled, randomized, multicenter study to test the hypothesis that NeuroAid is superior to placebo in reducing neurological deficit and improving functional outcome in patients with cerebral infarction of an intermediate range of severity.
详细描述
Stroke is a major cause of death and disability. Previous clinical studies performed in China have shown that NeuroAiD increase stroke patients'recovery in terms of neurological disability and functional outcome{Chen et al,2009}and thus may be beneficial as part of a post-stroke rehabilitation programme.
In the CHIMES study,we seek to test the hypothesis that NeuroAiD is superior to a placebo in reducing neurological deficit and improving functional outcome in patients recruited within 72 h after the ischemic stroke with intermediate range of severity {6<_NIHSS<_14}.More details of the study protocol have recently been published {Venketasubramanian et al,2009}.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is aged 18 years old and above (for Singapore 21 years and above as this is the legal age of consent)
- •Subject is on anti-platelet therapy
- •Subject is presented a pre-stroke Modified Rankin Scale inferior or equal to 1
- •Female subject is eligible to participate in the trial if she is of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post menopausal)
- •Subject or his/her legally acceptable representative is willing to provide written informed consent
- •Subject is presented with cerebral infarction with compatible imaging at Computed Tomography (CT) scan or Magnetic Resonance Imaging (MRI)
- •Time window is less than 72 hours after symptoms onset
- •Subject with cerebral infarction with intermediate severity range: 6 ≤ NIHSS ≤ 14
排除标准
- •Subjects deemed unstable by investigator after thrombolysis treatment
- •Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
- •Subject has a rapidly improving neurological deficit
- •Subject has definite indication for full-dose or long-term anticoagulation therapy
- •Subject has other significant non-ischemic brain lesion which could affect function disability
- •Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine > 200 μmol/L, if known), cirrhosis, severe dementia or psychosis
- •Subject has participated in another clinical trial within the last three months
研究组 & 干预措施
A
NeuroAid
干预措施: NeuroAid (Drug)
B
NeuroAid matched Placebo
干预措施: NeuroAid matched Placebo (Drug)
结局指标
主要结局
Distribution modified Rankin Scale grades for all randomized subjects
时间窗: 3 months
次要结局
- NIHSS, Barthel Index, MMSE(3 months)