Chinese Assessment for Vinpocetine In Neurology
关键词
抽象
描述
The design of this study is a randomized, open, multi-center and control study. The patients with cerebral infarction are as the study objects. Coronal CT / MRI examination combined with NIHSS and Modified Ranking Scale, MMSE, Barthel index, Transcranial Doppler (TCD) examination are applied to evaluate the Vinpocetine treatment efficacy and safety for cerebral infarction [14]. From ethical side, all patients will receive a conventional therapy, and based on it, the test group will be given intravenous injection of Vinpocetine as add-on treatment. Observation period is 10-14 days, and follow up for 3 months.
日期
| 最后验证: | 07/31/2013 |
| 首次提交: | 07/18/2011 |
| 提交的预估入学人数: | 07/20/2011 |
| 首次发布: | 07/21/2011 |
| 上次提交的更新: | 08/13/2013 |
| 最近更新发布: | 08/15/2013 |
| 实际学习开始日期: | 04/30/2010 |
| 预计主要完成日期: | 01/31/2013 |
| 预计完成日期: | 04/30/2013 |
状况或疾病
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| test group, control group Test group: Patients will be given cytidine diphosphate choline 0.4-0.5g, aspirin 75-100mg or Clopidogrel 75mg, intravenous infusion of Cavinton 30mg once a day.
Control group: Patients will be given cytidine diphosphate choline 0.4-0.5g, aspirin 75-100mg or Clopidogrel 75mg once a day. |
资格标准
| 有资格学习的年龄 | 40 Years 至 40 Years |
| 有资格学习的性别 | All |
| 取样方式 | Probability Sample |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Male or female, age 40-80 - The onset of the infarction between 48 hours and 1 month - CT / MRI results show cerebral infarction with deficit of neurological function. - CT or MRI confirms no intracranial hemorrhage - NIHSS score ≥ 3 - The subject agree to sign the informed consent form Exclusion Criteria: - Evidence of acute or chronic intracranial hemorrhage, subarachnoid hemorrhage, intracranial arteriovenous malformation, aneurysm or neoplasm based on CT / MRI examination - NIHSS score ≥ 17 - Coma patient - Existed disorders or conditions that would interfere neurological assessments (eg. dementia, psychiatric disorder, etc.) - Intracranial tumor, arteriovenous malformation, aneurysm, or intracranial surgery - Active peptic ulcer disease - Complicated with severe hepatic and renal disorder (ALT, AST 3.0 times higher than normal value; BUN or Cr more than 1.5 times the normal value) and severe disorder in hematopoietic system and endocrine system. - Bleeding tendency or blood disease - Plan to perform operation and carotid angioplasty - With severe congestive heart failure or acute myocardial infarction - Participate in other clinical trials at the same time, or withdrawal within 3 months - Allergic or contraindicated to vinpocetine or other treatment medication - Investigator think the subject is not suitable to participate in this trial |
结果
主要结果指标
1. Mini-Mental State Examination (MMSE)and Modified Rankin Scale [May 2010 - Feb. 2013]
次要成果指标
1. Barthel index and NIHSS [May. 2010 - Feb. 2013]
