NCT00789269Unknown2 期
Effectiveness and Safety of Rhubarb for the Treatment of Patients Who Have Suffered From a Stroke
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The lung infection rate within 14 days after stroke onset
研究概览
简要总结
This study will determine if rhubarb will reduced the incidence of pneumonia and improved recovery from an acute stroke. The study is designed to look at both infection rate and overall recovery and recovery of motor function, for example muscle strength and coordination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Occurrence of an acute ischemic stroke (between 9 and 72 h after onset) with a score of at least 6 on the National Institute of Health Stroke Scale (NIHSS), and patient age of at least 18 years.
- •Have no pneumonia according to modified criteria of the U.S. Centers for Disease Control and Prevention (CDC)
- •Consistent with the Constipation of Phlegm-Heat Accumulation type by Traditional Chinese Medicine (TCM) standard
- •Patients or their representatives voluntarily take part in this study and signed the informed consent
排除标准
- •Cerebral hemorrhage, subarachnoid hemorrhage
- •Transient ischemic attack(TIA)
- •Proven cerebral embolism caused by tumor, Brain Trauma, cerebral parasitic disease, dysbolismus, fibrillation atrial resulted from rheumatic heart disease, coronary heart disease, and other heart diseases
- •Clinical signs of infection on admission
- •Pregnant or breast-feeding
- •Allergic to rhubarb
- •Preceding or ongoing antibiotic therapy within the last 24 h
- •Participation in another interventional trial
- •Immunosuppressant treatment within the last 30 days
- •Combining severe clinical conditions such as liver, kidney, Hematopoietic System, endocrine system or psychological diseases
研究组 & 干预措施
1
Experimental
rhubarb
干预措施: rhubarb (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
The lung infection rate within 14 days after stroke onset
时间窗: 14 days
次要结局
- Global disability on modified Rankin scale(90 days)
- NIH stroke scale(90 days)
- Barthel Index(90 days)
- Death rate(90 days)
- Syndrome score by Traditional Chinese Medicine (TCM) standard(90 days)
- Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transaminase (ALT), aspartate transaminase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples, etc.(90 days)
研究者
研究点 (1)
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