Randomized, Double Blind, Placebo Control Trial to Evaluate the Efficacy of Astragalus Membranaceus in the Patients After Stroke With Fatigue
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- EORTC QLQ-C30
研究概览
简要总结
The high levels of fatigue in stroke patients without neurological impairment suggest it has a central origin rather than being the result of increased physical effort required after stroke（Winward et al., 2009）. Fatigue is different from post-stroke depression and the more serious stroke patients are more prone to fatigue（Windward et al., 2009）.
Fatigue is one of the symptoms of qi deficiency,and Astragalus membranaceus is the most effective of all traditional Chinese medicine and can tonifying middle and tonify the original qi. Therefore, the aim of this study was to investigate the efficacy of Astragalus membranaceus on post-stroke fatigue.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender: Male or female.
- •Age: between 40 and 80 years old.
- •Three months after stroke.
- •Hemorrhagic stroke or ischemic stroke.
- •Fatigue score from screen process ≧
- •Subject with comprehension or communication.
- •Volunteer signs the agreement to participate the study after whole study purpose and procedures description in detail.
排除标准
- •People from mental illness can not to participate the evaluation.
- •Major diseases such as cancer、Chronic pulmonary obstructive disease(COPD)、 Heart failure、Myocardial Infraction、Chronic renal failure or Liver cirrhosis.
- •Pregnant woman.
- •Breast-feeding woman.
研究组 & 干预措施
Chinese Herb Astragalus membranaceus
干预措施: Chinese Herb Astragalus membranaceus (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
EORTC QLQ-C30
时间窗: 2 year(all patients)
BFI-T score
时间窗: 2 years(all patients)
次要结局
- SF-36 score(2 years(all patients))