NCT00817609Unknown2 期
Effectiveness and Safety of Angongniuhuang Pill on Restoring Consciousness for 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
- 60
- 试验地点
- 1
- 主要终点
- Glasgow Coma Scale (GCS) within 90 days after stroke onset.
研究概览
简要总结
This study will determine if Angongniuhuang Pill (Composed of Niuhuang, Yujin, Xijiao, Huangqin, Huanglian, Xionghuang, Zhizi, Zhusha, Bingpian, Shexiang, and Zhenzhu) will have a better effect in restoring consciousness for patients who have suffered from an acute ischemic stroke. The study is designed to look at both consciousness level 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（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 not higher than 12 of Glasgow Coma Scale (GCS)
- •Patient age of between 18 and 80 years.
- •Patients or their representatives voluntarily take part in this study and signed the informed consent
排除标准
- •Transient Ischemic attack(TIA), cerebral hemorrhage, subarachnoid hemorrhage
- •Ischemic stroke that needs rt-PA treatment
- •Subjects who are unlikely to complete taking the investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition.
- •Pregnant or breast-feeding.
- •Proven disability by law, such as blindness, deafness, dumb, disturbance of intelligence, mental disorders, limb handicap.
- •Liable to be allergic (allergic to at lease 2 foods/drugs previously exposed)
- •Had been participated in other clinical trials during the last 1 month prior to study inclusion.
研究组 & 干预措施
A
Experimental
干预措施: Angongniuhuang Pill (Drug)
B
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Glasgow Coma Scale (GCS) within 90 days after stroke onset.
时间窗: 90 days
次要结局
- The percentage of patients of different consciousness level stratified according to the GCS, and the time spent of patients who recovered from coma.(90 days)
- Global disability on modified Rankin scale at 90 days.(90 days)
- NIH stroke scale(90 days)
- Changes in laboratory indexes as safety assessment, including red blood cell(RBC), white blood cell(WBC), platelet(PLT), alanine transarninase(ALT), aspartate transarninase (AST), blood urea nitrogen (BUN), creatinine(Cr) in blood samples; protein, red b(14 days)
研究者
研究点 (1)
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