NCT01048411已完成不适用
Multicenter Randomized Controlled Trial to Investigate the Influence of the Homeopathic Remedy 'Naja-comp' on Stroke Therapy in Geriatric Rehabilitation
University of Erlangen-Nürnberg Medical School3 个研究点 分布在 1 个国家目标入组 344 人开始时间: 2006年1月最近更新:
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
- 344
- 试验地点
- 3
- 主要终点
- barthel-index
研究概览
简要总结
The homeopathic remedy 'naja-comp' will improve functional outcome measured by the Barthel-Index.
The homeopathic remedy 'naja-comp' will decrease complications during geriatric rehabilitation measured by rate of unplanned discharge to hospital.
详细描述
Secondary outcome for functional improvement are Scandinavian Stroke Scale, 4D+S-Scale and Timed-Up&Go-Test.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke within 60 days after onset
排除标准
- •stroke by injury or tumor
- •stroke older than 60 days
- •missing consent for participation
- •participation at other clinical trials
研究组 & 干预措施
Naja-comp.
Active Comparator
s.c. injection of naja comp (homeopathic remedy) three times a week
干预措施: Naja-comp. (Drug)
Placebo
Placebo Comparator
s.c. injection of placebo (NaCl-solution) three times a week
干预措施: Placebo (Drug)
结局指标
主要结局
barthel-index
时间窗: baseline, 21st day of rehabilitation
rate of unplanned discharge to hospital care
时间窗: until day 21 of rehabilitation
次要结局
- Scandinavian Stroke Scale, 4D+S-Scale, Timed-Up&Go-Test(baseline, 21st day of rehabilitation)
研究者
研究点 (3)
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