Study on the Curative Effect and Autonomic Nerve Function of Primary Insomnia Patients with Liver Depression and Spleen Deficiency Type Based on Acupoint Selection of Meridian Theory
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Sleep quality measured by Pittsburgh sleep quality index ( PSQI)
研究概览
简要总结
The classical literature combined with modern medicine to select acupoints, in order to intervene in the autonomic nerve function of the superior cervical sympathetic ganglion as an opportunity, put forward the meridian acupoints mainly to reconcile the head orifices Ying Wei, acupuncture treatment of primary insomnia clinical research. Heart rate variability ( HRV ), Pittsburgh sleep quality index ( PSQI ), polysomnography ( PSG ) and the MOS item short from health survey ( SF-36 ) were observed. Insomnia Severity Index ( ISI ), Dysfunctional Beliefs and Attitudes about Sleep Scale 16 ( DBAS-16 ), GABA, Glx and other secondary indicators were used to clarify the clinical short-term and long-term efficacy of different acupoints in the treatment of patients with primary insomnia and the intervention effect on HRV.
详细描述
In this randomized controlled trial, 96 patients with insomnia of liver depression and spleen deficiency type were selected from the Third Affiliated Hospital of Zhejiang University of Traditional Chinese Medicine. All patients will be randomly assigned to the control group or the acupuncture group.
MAIN OUTCOME MEASURES : Pittsburgh Sleep Quality Index ( PSQI ) was used to measure sleep quality, and 36-Item Short Form Health Survey ( SF-36 ) was used to measure quality of life. Secondary outcomes included the Insomnia Severity Index ( ISI ), Sleep Dysfunction Beliefs and Attitudes Scale 16, DBAS-16, GABA and Glx.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •In line with the diagnostic criteria of insomnia of liver depression and spleen deficiency type in traditional Chinese medicine :
- •In line with the Western diagnostic criteria for insomnia ;
- •18 ≤ age ≤ 40 years old, male or female ;
- •patients with a course of more than two weeks ; Note: The above criteria must be met for inclusion in this study.
排除标准
- •Insomnia caused by a variety of organic diseases, neurological or psychiatric disorders
- •Pregnancy, lactation or drug allergy
- •There are more serious primary diseases such as cardiovascular and cerebrovascular diseases, gastrointestinal diseases, endocrine system diseases, or psychiatric patients.
- •Patients with coagulation dysfunction and bleeding tendency.
结局指标
主要结局
Sleep quality measured by Pittsburgh sleep quality index ( PSQI)
时间窗: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
The patients will be assessed by PSQI Chinese fixed questionnaire at each observation point and the clinical efficacy will be observed.It consists of 19 self-evaluation and 5 other-evaluation items. Only 19 self-evaluation questions are scored, and 19 self-evaluation questions are composed of 7 factors, each factor consists of 7 factors of 0-3 points. '0 ' refers to no difficulty, ' 3 ' refers to very difficult. The total score of ' 21 ' refers to very difficult in all respects. The sum of all factor scores constitutes the total score of the 0-21 scale. The reference boundary value of adult sleep quality problems in China : poor sleep quality : PSQI ≥ 8 ; good sleep quality : PSQI ≤ 7 ; the higher the score, the worse the sleep quality.
Quality of life measure by 36-item short form health survey（SF-36）
时间窗: Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.
The patients will be evaluated by SF-36 scale at each observation point. The SF-36 scale is a general scale developed by the American Medical Research Group to evaluate the quality of life. It is widely recognized and widely used in the world. This scale has eight dimensions to evaluate health-related quality of life ( HRQOL ), which belong to two categories of physical health and mental health, namely physiological function ( PF ), role physical ( RP ), bodily pain ( BP ), general health ( CH ), vitality ( VT ), social function ( SF ), role emotional ( RE ), mental health ( MH ). In addition, the SF-36 scale also includes another indicator - health change ( HT ), which is used to evaluate health changes over the past year.Add the scores of each item to the actual score, and then calculate the final score RP according to the following formula. The higher the RP score, the better the health status.
次要结局
- Insomnia Severity Index（ISI）(Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.)
- Dysfunctional Beliefs and Attitudes about Sleep Scale 16，DBAS-16 (DBAS-16)(Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.)
- GABA(Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.)
- Glx(Before treatment, 4 weeks of treatment, and 4 weeks after the end of treatment, three time points were observed.)
研究者
Chuanlong Zhou
Deputy Chief Chinese Physician
The Third Affiliated hospital of Zhejiang Chinese Medical University