NCT06049498已完成不适用
Efficacy and Safety of Mongolian Medicine ZhenBao Pills on Limb Function Recovery After Acute Ischemic Stroke: a Randomized Double-blinded Placebo-controlled Trial.
Dongzhimen Hospital, Beijing2 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 2
- 主要终点
- The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores
研究概览
简要总结
The trial was designed to test the hypothesis that treatment with Mongolian Medicine ZhenBao Pills has a positive effect on upper-limb motor recovery after acute ischemic stroke.
详细描述
The study is a randomized, double-blinded, placebo-controlled, multi-center trial.
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
- •Adult subjects (male or female ≥18 years).
- •The diagnosis of ischemic stroke should be met and the onset should be within 30 days.
- •Patients with prestroke modified Rankin scale score 0-
- •FAM-UE score of 20-57 at randomization.
- •The patients and legal guardians signed informed consent.
排除标准
- •Cranial CT or MRI findings of hemorrhage or other pathologic brain disorders, such as vascular malformations, tumors, abscesses, encephalitis, or other common non-ischemic brain diseases (e.g., multiple sclerosis).
- •Chronic liver disease or elevated ALT, AST (greater than two times the upper limit of normal), renal insufficiency or elevated blood creatinine (greater than 1.5 times the upper limit of normal).
- •Coagulation disorders or history of systemic hemorrhage.
- •Life expectancy is less than 3 months.
- •Unable to complete the study due to mental illness, cognitive or emotional impairment.
- •Suspected or known allergy to the components of the trial medication.
- •Pregnancy, breastfeeding or potential pregnancy.
- •Treatment within the last 3 months that may affect limb function, such as botulinum toxin injections or medications to improve limb motor function, etc.
- •Within three months or currently participating in another investigational study.
- •Other patients who, in the opinion of the investigator, are not suitable for participation of the study.
研究组 & 干预措施
Mongolian Medicine ZhenBao Pills group
Experimental
Experimental group
干预措施: Mongolian Medicine ZhenBao Pills (Drug)
Mongolian Medicine ZhenBao Pills Placebo-controlled group
Placebo Comparator
Placebo-controlled group
干预措施: Mongolian Medicine ZhenBao Pills Placebo (Drug)
结局指标
主要结局
The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) scores
时间窗: 90 days after randomization
Difference in FMA-UE scores (range =0-66, with lower scores indicating more severe limb dysfunction) between baseline and 90 days after randomization.
次要结局
- Modified Rankin scale (mRS) scores(90 days after randomization)
- FMA-UE scores(30 days after randomization)
- The Fugl-Meyer Assessment for Lower Extremity (FMA-LE)scores(90 days after randomization)
- Visual analogue scale (VAS) scores(90 days after randomization)
- National Institutes of Health Stroke Scale (NIHSS) scores(90 days after randomization)
- The Barthel index of activity of daily living (BI)(90 days after randomization)
研究者
Ying Gao
Professor
Dongzhimen Hospital, Beijing
研究点 (2)
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