Clinical Study to Investigate the Safety and Efficacy of MLC601 in 150 Iranian Patients After Stroke
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 150
- 主要终点
- Investigate the Safety and Efficacy of MLC601
研究概览
简要总结
To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese Medicine on motor recovery after ischemic stroke.
详细描述
This is a double-blind, placebo-controlled clinical trial study on 150 patients with a recent (less than 3 month) ischemic stroke. All patients will give either MLC601 (100 patients) or placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard medication of post stroke for 3 months. Motor improvement will be monitored using Fugl-Meyer Assessment FMA.
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
- 30 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 30-72 yars,
- •< one month after stroke,
- •ischemic cerebral stroke,
- •signed informed consent form.
排除标准
- •treatment with thrombolytic after stoke,
- •ischemic stroke combined with hemorrhage, severe renal or liver failure, dementia, psychosis and history of seizure disorder, history of previous stroke, and hemoglobin level less than 10mg/dl on admission.
研究组 & 干预措施
MLC601
MLC601 (NeuroAideTM) is a TCM which is used extensively in China to improve recovery after stroke. It combines several herbal and animal components.
干预措施: MLC601 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Investigate the Safety and Efficacy of MLC601
时间窗: 18 months
Patients showed a good tolerability to treatment and adverse events were mild and transient.
次要结局
- Motor recovery of MLC601 in 150 Iranian Patients after Stroke(18 months)