CHInese Medicine NeuroAid Efficacy on Stroke Recovery
关键词
抽象
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}.
日期
| 最后验证: | 03/31/2014 |
| 首次提交: | 11/04/2007 |
| 提交的预估入学人数: | 11/04/2007 |
| 首次发布: | 11/06/2007 |
| 上次提交的更新: | 04/29/2014 |
| 最近更新发布: | 04/30/2014 |
| 实际学习开始日期: | 04/30/2007 |
| 预计主要完成日期: | 07/31/2012 |
| 预计完成日期: | 07/31/2012 |
状况或疾病
干预/治疗
Drug: A
Drug: B
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: A NeuroAid | Drug: A 4 capsules 3 times daily, for three months |
| Placebo Comparator: B NeuroAid matched Placebo | Drug: B NeuroAid matched Placebo, 4 capsules 3 times daily, for three months |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
结果
主要结果指标
1. Distribution modified Rankin Scale grades for all randomized subjects [3 months]
次要成果指标
1. NIHSS, Barthel Index, MMSE [3 months]
