Scheme Optimization of Acupoints Compatibility and Influence Factors of the Effect
试验速览
- 阶段
- 1 期
- 入组人数
- 333
- 试验地点
- 1
- 主要终点
- Pittsburgh sleep quality index(PSQI)
研究概览
简要总结
With primary insomnia as the research object, by the method of multi-center RCT and needle single cavity and different acupoints compatibility treatment for primary insomnia, to Pittsburgh sleep quality index(PSQI) and evaluation, sleep log evaluation and Polysomnogram(PSG) as the means, such as the single cavity with different acupoints compatibility evaluate clinical curative effect of treating primary insomnia.
详细描述
In order to establish a spectrum of acupoints compatibility of the law, is clear about the factors affecting the compatibility effect of acupoints, the formation of strong operability of acupoints compatibility optimization evaluation method, the project choice of the clinical acupuncture and moxibustion have curative effect of primary insomnia as the breakthrough point of the study, carried out clinical multi-center RCT research, through objective and scientific evaluation method, comparing the effect of different acupoints compatibility.
Primary insomnia in clinical common disease, frequently-occurring disease, acupuncture curative effect is distinct, disease diagnosis, curative effect evaluation standard. Previous clinical data also show that the primary insomnia is acupuncture clinical diseases. This project by primary insomnia as the research object, research to better guide clinical practice, improve the clinical curative effect, promote acupuncture of the inheritance and innovation, promote scientification of acupuncture and moxibustion, modernization and internationalization, and will have broad prospect of application and significant scientific research value.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Insomnia 's Disease;
- •Aged 18-60 (including 18 and 60);
- •Does not attend other clinical researchers;
- •Participation in the researchers signed informed consent and voluntary;
- •Pittsburgh sleep index (PSQI) index > 7 points;
- •Athens scale or 6 points;
- •Depression scale and anxiety scale 50 points or less.
排除标准
- •Breathing-Related Sleep disorder;
- •Circadian rhythm disorders;
- •Sleep disorders;
- •Drug-induced insomnia (such as drug abuse, drug treatment);
- •Sleep disorders caused by poor diet, lifestyle factors(Long-term excessive drinking, coffee, tea, etc.);
- •All systemic diseases (such as pain, fever, cough, surgery, etc.) and the external environment disturbance factors;
- •With cardiovascular, lung, liver, kidney and hematopoietic system such as serious primary diseases;
- •Patients with mental illness;
- •Pregnancy or breast-feeding women;
- •Acupoints with severe skin infections;
- •Patients who are afraid of acupuncture;
- •Advanced malignant tumor or other serious wasting disease, infection and bleeding;
- •Who do not meet the inclusion criteria, poor compliance, treatment, not according to stipulations can not judge the curative effect or data not congruent affect curative effect and safety of judgment;
- •Caused by excessive anxiety and depression of patients with insomnia.
研究组 & 干预措施
Single point group (Shenmen)
Patients will be acupuncture with Shenmen(HT7).
干预措施: acupuncture (Other)
Sancai coordinated points group
Patients in Sancai coordinated points group, will be acupuncture with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6).
干预措施: acupuncture (Other)
Control group
Patients in Control group, will be acupuncture with at the junction of deltoid and biceps.
干预措施: acupuncture (Other)
结局指标
主要结局
Pittsburgh sleep quality index(PSQI)
时间窗: 9 weeks
次要结局
- Sleep diary(5 weeks)
- Athens insomnia scale(9 weeks)
- Change in Total Sleep Time Measured by PSG(5 weeks)
- Self-rating anxiety scale(SAS)(1 week)
- Self-Rating Depression Scale(SDS)(1 week)
- Test GABA,Glu,5-HT,Ach,NE,DA in the human brain to reflect the state of brain function by the Encephalofluctuograph(ET)(5 weeks)
研究者
Tie Li
973 project management deputy director of the office
Changchun University of Chinese Medicine