Exploring Changes in Sleep Assessment of Patients With Sleep-related Diseases Treated by Chinese Medicine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI) scores
研究概览
简要总结
The investigators recruited patients ages 20-65 from 2 groups in Tainan Hospital. One was from a weight loss class, also called WLC, one was from our regular clinic. These patients have no history of schizophrenia, narcolepsy, neurological disease, alcohol and drug addiction but had Pittsburgh Sleep Quality Index (PSQI) scores for psychometric properties ≥ 5 between January 1 to November 30 of 2019. The study group were the patients who received XYS for 28 days and the control group were those who didn't receive any Chinese medicine but attended the WLC. Age, gender, personal biodata, polysomnography findings, and these subjective sleep questionnaires were collected. The Wilcoxon test was used to compare the difference in pre and post evaluation in two groups. After comparing the objective and subjective assessment between the better and poorer performance in the XYS group, we would find more suitable criteria for XYS in traditional Chinese medicine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20- to 65-year-old patients.
- •Pittsburgh Sleep Quality Index (PSQI) scores ≥ 5.
排除标准
- •Schizophrenia.
- •Narcolepsy.
- •Neurological diseases (history of stroke, neurodegenerative diseases, etc.).
- •Alcohol addiction.
- •Drug addiction.
研究组 & 干预措施
Xiao-Yao-San group
Received Xiao-Yao-San for 28 days
干预措施: Xiao-Yao-San (Drug)
weight loss class group
The control group were those who didn't receive any Chinese medicine but attended the weight loss class.
干预措施: Weight loss class(WLC) group (Other)
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI) scores
时间窗: Up to 12 weeks.
Sleep quality
次要结局
未报告次要终点
研究者
Yu-Ching HSU
Tainan Hospital, Ministry of Health and Welfare
Tainan Hospital, Ministry of Health and Welfare
