Clinical trial NCT02402959: Individualized Treatment With Traditional Chinese Medicine for the Patients With Insomnia Disorder: a Cohort Study
Official title: Individualized Treatment With Traditional Chinese Medicine Pattern Differentiation for the Patients With Insomnia Disorder: a Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep Initiation and Maintenance Disorders
Keywords: Insomnia
Traditional Chinese Medicine
herbal medicine
cohort study
individualized treatment
TCM pattern differentiation
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: National Natural Science Foundation of China
First posted: 2015-03-31
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the diagnosis of insomnia, who come to the experts' clinic for treatment, will be invitated and included in his cohort.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients with the diagnosis of insomnia;
2. Patients' age between 18 and 65 years (18 and 65 years included);
3. Patients with the oral or written informed consent.

Exclusion Criteria:

1. 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.
2. Psychopath with suicidal tendency;
3. Patients with pregnancy and lactation.

Primary outcomes:
measure: Change from baseline in the Sleep Quality
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
Secondary outcomes:
measure: Change from baseline in the diagnosis of insomnia
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
measure: Change from baseline in the Insomnia Severity
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
measure: Change from baseline in the Patient's satisfaction to the TCM treatment
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
measure: Change from baseline in the Insomnia severity and improvement
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
measure: Change from baseline in the Clinician's satisfaction to the TCM treatment
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
measure: Change from baseline in the Reduction of western medicine
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
measure: Change from baseline in the Sleep structure
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
measure: Change from baseline in the Depression/Anxiety severity
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
measure: Change from baseline in the Other measures that experts regard them necessary.
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
measure: Adverse Event
timeFrame: Week 1, 2, 4, 6, 8 or Final visit.
Other outcomes:
Locations:
city: Beijing
country: China
facility: East Hospital of Beijing University of Traditional Chinese Medicine
state: Beijing
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of China Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of China Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Guang'anmen Hospital of China Academy of China Medical Sciences
state: Beijing
city: Fuzhou
country: China
facility: Fujian Institute of Traditional Chinese Medicine
state: Fujian
city: Shenzhen
country: China
facility: Shenzhen hospital of Traditionl Chinese Medicine
state: Guangdong
city: Zhengzhou
country: China
facility: Affiliated hospital of He'nan university of Traditional Chinese Medicine
state: Henan
city: Wuhan
country: China
facility: Clinic of Hubei university of Traditional Chinese Medicine
state: Hubei
city: Ji'nan
country: China
facility: Affiliated hospital of Shandong university of Traditional Chinese Medicine
state: Shandong
Study officials:
affiliation: China Academy of Chinese Medical Sciences
name: Baoyan Liu, Master
role: PRINCIPAL_INVESTIGATOR
References: