Clinical Normative Evaluation of Chronic Insomnia Treated by Traditional Chinese Medicine According to Yin Yang Theory and Its Correlation With Circadian Rhythm
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of Traditional Chinese medicine (TCM) according to Yin Yang theory for treatment of chronic insomnia .
详细描述
All subjects giving written informed consent. In this multicenter, controlled, prospective cohort study, the outpatient and inpatient chronic insomnia patients' baseline demographic data were collected, including age, gender, education background, and medication history. Venous blood samples were collected and sent to laboratory test for blood routine, and blood biochemistry at Baseline and Week 4. The Pittsburgh sleep quality index (PSQI) was used to assess the patients' sleep quality at baseline and week 4. Objective sleep quality data is assessed by wearing a Sleep wearable devices. The classic Morningness-Eveningness Questionnaire and wearable devices was used to assess the patients' chronotype at baseline and week 4.Subjects who visit the TCM clinic of this project received Suanzaoren Decoction and Huanglian Wendan Decoction orally twice daily for 4 weeks. Add or subtract Chinese herbal medicine according to the different clinical manifestations of each patient. Subjects from TCM clinic who had previously taken Western medicine hypnotics continued taking them, and for those who had not taken before, Western medicine hypnotics shall not be given/prescribed. Subjects who visit the Western medicine clinic of this project received Estazolam 1mg tablet orally once daily for 4 weeks. The participants will have a follow-up visit every two weeks, and the prescription would be adjusted according to the condition of illness.Cessation rate of Western medicine hypnotics was assessed at Month 6.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients or inpatients.
- •It conforms to the chronic insomnia diagnosis standard of Chinese adult insomnia diagnosis and treatment guide (2017 Edition).
- •Chronic insomnia patients with Yin yang imbalance and Ying Wei Disharmony Syndrome.
- •Informed consent, voluntary participation in the study.
排除标准
- •Sleep apnea syndrome leads to insomnia.
- •Severe depression, suicidal tendency or having committed suicide.
- •Pregnant and lactating women.
- •It has serious primary heart, liver, lung, kidney, blood or serious diseases affecting its survival, such as: tumor or AIDS, SCR > 1.5n (n is the upper limit of normal value), ALT > 2n (n is the upper limit of normal value), WBC < 3.0 × 109 / L;
- •Those who cannot give full informed consent due to mental disorders.
- •According to the researcher's judgment, other situations that are not suitable for the group, such as the change of working environment.
- •Subjects who are participating in other clinical studies.
研究组 & 干预措施
Chinese medicine group
Participants received Suanzaoren Decoction and Huanglian Wendan Decoction orally twice daily for 4 weeks.
Subjects who had previously taken Western medicine hypnotics continued to take them, and those who did not take them did not add Western medicine hypnotics.
干预措施: Suanzaoren Decoction and Huanglian Wendan Decoction (Drug)
Western medicine group
Participants received Estazolam 1mg tablet orally once daily for 4 weeks.
干预措施: Estazolam 1Mg Tab (Drug)
结局指标
主要结局
Change from Baseline in the total score of the Pittsburgh sleep quality index (PSQI) at 4 weeks
时间窗: Baseline and Week 4
The Pittsburgh sleep quality index (PSQI) is a validated,self-reported instrument assessing the sleep quality over the past 4 week period. Possible scores range from 0(the best sleep quality) to 21(the worst possible sleep) quality).The higher the score of PSQI, the worse the sleep quality. Change=(Month 1 Score-Baseline Score)
Cessation rate of Western medicine hypnotics at Month 6
时间窗: Month 6
Cessation was defined as an absence of any Western medicine hypnotics that was sustained for 3 consecutive months or more. Cessation rate of Western medicine hypnotics=(Month 6 number-Baseline number)/Baseline number of Participants use Western medicine hypnotics.
次要结局
- Change from Baseline of the AST at 4 weeks(Baseline and Week 4)
- Change from Baseline of the BUN at 4 weeks(Baseline and Week 4)
- Change from Baseline of the Scr at 4 weeks(Baseline and Week 4)
- Genome-wide association study(Month 6)
- Change from baseline objective sleep quality(Baseline and Week 4)
- Change from Baseline of the ALT at 4 weeks(Baseline and Week 4)
- Change from Baseline in the score of Morningness-Eveningness Questionaire (MEQ)(Baseline and Week 4)