NCT00710164Unknown2 期
Effectiveness and Safety of Xiaoshuanchangrong (XSCR) Capsule 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
- 130
- 试验地点
- 20
- 主要终点
- Global disability on modified Rankin scale
研究概览
简要总结
This study will determine if Xiaoshuanchangrong (XSCR) capsule will improve recovery from an acute stroke. The study is designed to look at both 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute ischemic stroke with limb weakness, NIH stroke scale ≥6, limb weakness score ≥2
- •Onset of symptoms within 72 hours
- •18 Years and older
- •Consistent with the Qi deficiency and Blood stasis 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
- •Transient ischemic attack(TIA), cerebral hemorrhage, subarachnoid hemorrhage
- •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: XSCR capsule (Composed of Traditional Chinese Medicine Huangqi, Chuanxiong, Chishao, Danggui, Dilong, Taoren, Honghua.) (Drug)
B
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Global disability on modified Rankin scale
时间窗: 90 days
次要结局
- NIH stroke scale(90 days)
- Barthel Index(90 days)
- Syndrome score by Traditional Chinese Medicine (TCM) standard(90 days)
- mini-mental state examination (MMSE)(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; protein, red b(90 days)
研究者
研究点 (20)
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