Program of TCM on Early Rehabilitation and Secondary Prevention of Ischemic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,151
- 试验地点
- 1
- 主要终点
- NIHSS Stroke Scale, relapse rate
研究概览
简要总结
Complex project of Traditional Chinese Medicine (TCM) with Western Medicine (WM) project under stroke unit mode contrast,assuming that the efficiency of TCM on early rehabilitation and secondary prevention of ischemic stroke is same or better than that of WM.
详细描述
As a multi-site randomized controlled clinical trial,through a central system,patients were randomly assigned to the intervention group or the control group.In the intervention group, patients were treated with the traditional Chinese medicine comprehensive rehabilitation program, which includes traditional Chinese medicine syndrome differentiation herbs, Chinese medicine injection, wash foam Chinese medicine, acupuncture,massage, and Chinese medicine health education. In the control group, patients were treated with Western-based treatment plus modern rehabilitation techniques.All patients were treated for 2 weeks. At the first day after the treatment and the 14 days after treatment, each patient was evaluated for the following three clinical indications: (1)evaluation of neurological deficits by U.S. National Institutes of Health Stroke Scale (NIHSS);(2) evaluation of motor function by the short form Fugl-Meyer motor function scoring system (FMI); and (3) assessment of limb spasticity by the modified Ashworth spasticity rating scale.
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
- None
入排标准
- 年龄范围
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According with the stroke diagnosis of Traditional Chinese Medicine
- •According to atherosclerotic thrombotic cerebral infarction from Western diagnosis such as medical history and CT / MRI examinations
- •It has attacked in 7 days
- •The assessment of scale of NIHSS:4-24 points
- •Age: ≥ 35 years and ≤ 75 years
- •Patients or their legal guardians sign informed consent form
排除标准
- •The patients with ICH or cerebral hemorrhage or TIA
- •It has attacked beyond 7 days
- •Patients with stroke history and the mRS ≥ 2 points before this attack
- •Mixed type of stroke (infarction after bleeding or bleeding after infarction)
- •Patients with cerebral infarction by cardiogenic embolism, blood hypercoagulable state and tunica intima exfoliating
- •Patients with serious heart disease;failure of heart or liver or kidney; cancer;digestive tract bleeding
- •Women of pregnancy or breast-feeding
- •Patients who are taking part in other clinical trials that will influence the results of this study
结局指标
主要结局
NIHSS Stroke Scale, relapse rate
时间窗: 360 days
次要结局
- adverse event(360 days)
研究者
Yanming Xie
Deputy Director
China Academy of Chinese Medical Sciences