The First Affiliated Hospital of Guangzhou University of Chinese Medicine
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Mortality rate
研究概览
简要总结
Maintenance hemodialysis (MHD) is one of the most important treatments for patients with end-stage renal failure. Studies have found that insomnia is widespread in MHD patients, affecting their quality of life. Auricular acupoint pressing is an effective traditional Chinese medicine treatment for insomnia. This study compared the effects of auricular acupoint pressing and oral estazolam on insomnia in patients with MHD, and evaluated the possibility of auricular acupoint pressing to reduce the incidence of adverse events by improving insomnia in patients with MHD, and to explore the insomnia of MHD patients treated with TCM characteristics. The role and efficacy provide a basis for the treatment of sleep disorders by Chinese medicine.
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
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.Age 18-90 years old，received maintenance hemodialysis treatment for more than 1 year, no history of surgical trauma, infection, trauma in the past 3 months; 2.the current condition is stable, the heart function is grade I, no limb paralysis, speech disadvantages and other sequelae； 3.Informed consent volunteer to participate in this experiment.
排除标准
- •At present, dialysis is inadequate, water and sodium retention is severe;
- •combined with severe cardiovascular disease, sequelae of cerebral infarction or history of cerebral hemorrhage, history of COPD, history of myasthenia gravis, history of angle-closure glaucoma, blood system disease, mental system disease or other systemic The disease can not be matched with the experimenter;
- •poor compliance or poor medical attitude;
- •severe hearing or vision loss, or a very low level of education, can not match the experiment.
研究组 & 干预措施
Auricular acupoint pressing group
干预措施: Auricular point pressure therapy (Other)
Oral estazolam group
干预措施: Oral estazolam medication (Drug)
Combined treatment group
干预措施: Auricular point pressure therapy (Other)
Combined treatment group
干预措施: Oral estazolam medication (Drug)
结局指标
主要结局
Mortality rate
时间窗: June 1, 2019 to June 1, 2021
Pittsburgh sleep quality index（PSQI）score
时间窗: June 1, 2019 to June 1, 2021
次要结局
- Gastrointestinal bleeding rate(June 1, 2019 to June 1, 2021)
- Incidence of cardiovascular events(June 1, 2019 to June 1, 2021)
- Cerebrovascular accident rate(June 1, 2019 to June 1, 2021)
研究者
Haitao Tu
Principal Investigator
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine