Effect of Moxibustion Intervention on Insomnia Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The score of PSQI
研究概览
简要总结
Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia.
Describe participant population/health conditions:120 insomnia patients
详细描述
Type of study:clinical trial Purpose of research:To explore the efficacy and safety of moxibustion combined with Traditional Chinese and Western medicine in treating insomnia.
Describe participant population/health conditions:120 insomnia patients The participants were enrolled according to the principle of randomization and single blindness, and the analysis was adjusted every quarter according to the research schedule. The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with only western medicine.
Clinical evaluation of the main efficacy indicators: The score of PSQI scale was assessed. The reduction rate of PSQI scale was ≥ 25% as effective, and the difference between the two groups was compared as the basis for evaluating the main efficacy indicators. The efficacy of insomnia symptoms was evaluated by the difference of PSQI score reduction rate between groups before and after intervention.
Secondary clinical outcome measures: Quality of Life Scale (SQLS), SF-36 scale, Clinical Gross Impression Scale (CGI), adverse reaction（TESS） .
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria of ICD-10 insomnia;
- •In line with the relevant diagnostic criteria of TCM syndrome differentiation of heart-spleen and deficiency type insomnia (TCM syndrome diagnosis criteria according to the 1993 Ministry of Health "Guidelines for Clinical Research on the treatment of Insomnia with new Chinese Medicine" standards: heart-spleen and deficiency: palpitation, amnesia, dizziness, poor and tired, pale face, easy to sweat, tongue, thin coat, thin pulse);
- •Pittsburgh Sleep Quality Index (PSQI) score > 7 at baseline;
- •The treatment plan used in this study is tolerable, cooperative and compliant;
- •Regardless of gender, age 18-65 years old;
- •Understand the procedure and content of the test, and voluntarily sign the informed consent;
排除标准
- •Participating in other clinical studies;
- •Exclude patients with serious physical diseases or diseases that may affect the evaluation of the test;
- •there is a clear risk of suicide or danger to oneself or others;
- •Exclude pregnant or lactating women, or those planning pregnancy;
- •Persons with alcohol and drug dependence within 1 year prior to screening.
研究组 & 干预措施
The study group(using the moxibustion)
The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine.
- The study group: Using the moxibustion, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment.
- The control group: Using the moxibustion with blank patch, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment.
- The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks.
干预措施: Traditional Chinese moxibustion apparatus (Device)
The control group(using the moxibustion with blank patch)
The study group was treated with traditional Chinese moxibustion and western medicine. The control group was treated with blank moxibustion and western medicine.
- The study group: Using the moxibustion, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment.
- The control group: Using the moxibustion with blank patch, select specific 3 groups of acupoints. Select a group of acupuncture points every day, in the moxibustion treatment for 20 minutes, 4 weeks for a course of treatment.
- The treatment period is 4 weeks, which is a course of treatment, and the observation period is 8 weeks.
干预措施: Traditional Chinese moxibustion apparatus (Device)
结局指标
主要结局
The score of PSQI
时间窗: Baseline, week two, week four, week eight
The reduction rate of PSQI scale ≥25% was regarded as effective, and the difference between the two groups was compared as the basis for evaluating the main therapeutic effect indicators. The efficacy of insomnia symptoms was evaluated by the difference in the reduction rate of PSQI scores between the two groups before and after the intervention.
次要结局
- The score of Quality of Life Scale (SQLS)(Baseline, week two, week four, week eight)
- The score of SF-36 scale(Baseline, week two, week four, week eight)
- The score of Clinical Gross Impression Scale (CGI)(Baseline, week two, week four, week eight)
- adverse reaction（TESS）evaluation(Baseline, week two, week four, week eight)