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临床试验/NCT06417515
NCT06417515已完成4 期

Exploring Changes in Sleep Assessment of Patients With Sleep-related Diseases Treated by Chinese Medicine

Yu-Ching HSU1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

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

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

Experimental

Received Xiao-Yao-San for 28 days

干预措施: Xiao-Yao-San (Drug)

weight loss class group

Other

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

发起方
Yu-Ching HSU
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yu-Ching HSU

Tainan Hospital, Ministry of Health and Welfare

Tainan Hospital, Ministry of Health and Welfare

研究点 (1)

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