Individualized Treatment With Traditional Chinese Medicine Pattern Differentiation for the Patients With Insomnia Disorder: a Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 7
- 主要终点
- Change from baseline in the Sleep Quality
研究概览
简要总结
The primary purpose of this study is to discover, establish and refine the individual treatment protocol of each TCM expert for insomnia, and to explore what characteristics of the patients are considered with the corresponding treatment in clinical practices.
The secondary purpose is to determine the effectiveness of TCM pattern differentiation treatment for the patients with insomnia.
详细描述
Traditional Chinese medicine (TCM) has been effectively and instantly used for keeping Chinese people's health over 2000 years. Recently the TCM is becoming popular and well known home and abroad due to its effectiveness and individualized treatment. It has been known that TCM practitioners diagnosed, give the treatment and evaluated patients' health condition with symptoms and signs, what are called TCM patterns. This is why TCM practitioners always consider and emphasize the importance of TCM patterns in the TCM education and clinic practices. At the same time, TCM pattern differentiation is considered complicated and difficult to understand, due to the difference of TCM practitioners'clincal experience and knowledge. The one ,who has more experience and knowledge, treat patients more effective than the other. Unlike modernized medicine, drugs are not always recommended for the diseases, conversely, the TCM practitioners and their knowledge are always recommended. In addition, young TCM practitioners have to follow and imitate the experts who are full of knowledge, if they want to be good ones. From these views, the experience and knowledge of experts are important and crucial to the clinical outcomes, meanwhile they are hard to discover and establish. Therefore, we package the experts and their treatment as the one target to discover, establish and refine the individual treatment protocol (experience and knowledge) of each TCM expert, and to explore what characteristics of the patients are considered with the corresponding treatment in clinical practices.
The prerequisite of the study is that experts chosen for the study are the ones who are the specialists on the insomnia treatment. So, the secondary purpose is to determine the effectiveness of TCM patter differentiation treatment for the patients with insomnia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with the diagnosis of insomnia;
- •Patients' age between 18 and 65 years (18 and 65 years included);
- •Patients with the oral or written informed consent.
排除标准
- •Patients with any uncontrolled and severe diseases which cause insomnia will be excluded. the diseases may include heart disease (like angina, cardiac arrhythmias, heart failure, myocardial infarction), pulmonary disease (COPD, asthma), gastrointestinal disorders (stomach or duodenal ulcers, reflux disease), neurologic disorders (seizures, spastic torticollis, blepharospasm, dystonias, parkinson's disease, alzheimer's disease, dementia, sleep-disruptive headaches), head trauma (blow to the head with loss of consciousness, concussion), pain disorders (fibrositis/fibromyalgia, arthritis, muscle cramps, chronic low back pain, headaches), endocrine and metabolic disorders (thyroid disease, diabetes), kidney disease (kidney failure with dialysis, kidney stones) autoimmune disorders, cancer, and HIV/AIDS.
- •Psychopath with suicidal tendency;
- •Patients with pregnancy and lactation.
结局指标
主要结局
Change from baseline in the Sleep Quality
时间窗: Week 1, 2, 4, 6, 8 or Final visit.
Measured by Pittsburgh Sleep Quality Index, PSQI
次要结局
- Change from baseline in the Patient's satisfaction to the TCM treatment(Week 1, 2, 4, 6, 8 or Final visit.)
- Change from baseline in the Other measures that experts regard them necessary.(Week 1, 2, 4, 6, 8 or Final visit.)
- Change from baseline in the diagnosis of insomnia(Week 1, 2, 4, 6, 8 or Final visit.)
- Change from baseline in the Insomnia Severity(Week 1, 2, 4, 6, 8 or Final visit.)
- Change from baseline in the Insomnia severity and improvement(Week 1, 2, 4, 6, 8 or Final visit.)
- Change from baseline in the Clinician's satisfaction to the TCM treatment(Week 1, 2, 4, 6, 8 or Final visit.)
- Change from baseline in the Reduction of western medicine(Week 1, 2, 4, 6, 8 or Final visit.)
- Change from baseline in the Sleep structure(Week 1, 2, 4, 6, 8 or Final visit.)
- Change from baseline in the Depression/Anxiety severity(Week 1, 2, 4, 6, 8 or Final visit.)
- Adverse Event(Week 1, 2, 4, 6, 8 or Final visit.)
研究者
Baoyan Liu
vice-president
China Academy of Chinese Medical Sciences