Individualized Treatment With Traditional Chinese Medicine for the Patients With Insomnia Disorder: a Cohort Study
1 other identifier
observational
600
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Shorter than P25 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 20, 2015
CompletedFirst Posted
Study publicly available on registry
March 31, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedMarch 31, 2015
March 1, 2015
9 months
March 20, 2015
March 30, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the Sleep Quality
Measured by Pittsburgh Sleep Quality Index, PSQI
Week 1, 2, 4, 6, 8 or Final visit.
Secondary Outcomes (10)
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 Patient's satisfaction to the TCM treatment
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.
- +5 more secondary outcomes
Study Arms (10)
Cohort 1
Based on the first TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.
Cohort 2
Based on the second TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.
Cohort 3
Based on the third TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.
Cohort 4
Based on the fourth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.
Cohort 5
Based on the fifth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.
Cohort 6
Based on the sixth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.
Cohort 7
Based on the seven TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.
Cohort 8
Based on the eighth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.
Cohort 9
Based on the nineth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.
Cohort 10
Based on the tenth TCM expert's experience and his knowledge, the insomnia patients will be treated with the best individualized treatment options, which should be at least in accordance to the current China Traditional Chinese herbal medicine pharmacopoeia and the China adult insomnia diagnosis and treatment guidelines. In addition, the expert could determine the treatment in consideration of individual patient's preferences and best existed evidence. Therefore, the choices of medicine, dosage form, dosage, frequency and duration are not restricted.
Interventions
Individualized treatment includes anything no matter what kind of interventions, like medicine, herbs, acupuncture, massage, behaviour therapy, diet and exercise therapy. The TCM experts should choose the intervention in accordance to the patients' preference, best existed evidence and their empirical knowledge.
Eligibility Criteria
Patients with the diagnosis of insomnia, who come to the experts' clinic for treatment, will be invitated and included in his cohort.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
East Hospital of Beijing University of Traditional Chinese Medicine
Beijing, Beijing Municipality, China
Guang'anmen Hospital of China Academy of China Medical Sciences
Beijing, Beijing Municipality, China
Guang'anmen Hospital of China Academy of China Medical Sciences
Beijing, Beijing Municipality, China
Guang'anmen Hospital of China Academy of China Medical Sciences
Beijing, Beijing Municipality, China
Fujian Institute of Traditional Chinese Medicine
Fuzhou, Fujian, China
Shenzhen hospital of Traditionl Chinese Medicine
Shenzhen, Guangdong, China
Affiliated hospital of He'nan university of Traditional Chinese Medicine
Zhengzhou, Henan, China
Clinic of Hubei university of Traditional Chinese Medicine
Wuhan, Hubei, China
Affiliated hospital of Shandong university of Traditional Chinese Medicine
Ji'nan, Shandong, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Baoyan Liu, Master
China Academy of Chinese Medical Sciences
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice-president
Study Record Dates
First Submitted
March 20, 2015
First Posted
March 31, 2015
Study Start
March 1, 2015
Primary Completion
December 1, 2015
Study Completion
February 1, 2016
Last Updated
March 31, 2015
Record last verified: 2015-03