NCT00721825已完成2 期
A Double-Blinded, Placebo-Controlled, Randomized Phase II Pilot Study to Investigate the Potential Efficacy of a Traditional Chinese Medicine NeuroAid In Enhancing Recovery After Stroke (TIERS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Fugl-Meyer assessment
研究概览
简要总结
TIERS is a phase II to generate detailed preliminary data on the efficacy of NeuroAid in post-stroke recovery, and to assess the utility of the rehabilitation outcome measure instruments used.
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
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject had cerebral infarction confirmed by Computed Tomography (CT scan or Magnetic Resonance Imaging (MRI) imaging
- •Presents within 1 month after stroke onset
- •Presents with motor power of from grade 1 - 4/5 in at least one limb
- •Has a pre-stroke modified Rankin score ≤
- •Age between 21 and 80 years old
- •Female subjects are eligible to participate in the trial if they are of non childbearing potential (hysterectomy or post-menopausal)
- •Subject or legally acceptable representative is willing and able to provide written informed consent
- •Subject and carer are willing and able to comply with investigational drug administration schedule.
排除标准
- •Subject has received thrombolysis
- •Subject has evidence of intra-cerebral hemorrhage on brain CT scan or MRI
- •Subject has definite indication for full-dose or long-term anticoagulation therapy
- •Subject has other significant non-ischemic brain lesion which could affect function disability
- •Subject has co-existing systemic diseases: terminal cancer, renal failure (creatinine >200 μmol/L, if known), cirrhosis, severe dementia or psychosis
- •Subject has a history of previous stroke/s
- •Subject has participated in another clinical trial within the last three months
- •Subject has aphasia or any other cognitive disabilities which prevent cooperation with study instructions
- •Subject has dense hemiplegia (grade 0 motor power)
- •Subject has haemoglobin level of <10mg/dl on admission
- •Subject has a history of craniotomy or seizures
研究组 & 干预措施
1
Active Comparator
Neuroaid
干预措施: Neuroaid (Drug)
2
Placebo Comparator
Neuroaid matched placebo
干预措施: Neuroaid matched Placebo (Drug)
结局指标
主要结局
Fugl-Meyer assessment
时间窗: 4 weeks
次要结局
- Functional Independence Measure (FIM) scale(4 weeks and 8 weeks)
- Fugl-Meyer subscores(4 weeks and 8 weeks)
- NIHSS and NIHSS subscores(4 weeks and 8 weeks)
研究者
研究点 (1)
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