Sleep Initiation and Maintenance DisordersNCT02402959
Individualized Treatment With Traditional Chinese Medicine for the Patients With Insomnia Disorder: a Cohort Study
An observational study of Sleep Initiation and Maintenance Disorders, run by China Academy of Chinese Medical Sciences at 9 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- individualized treatment
- How many people
- 600 participants
- Where
- 9 sitesChina
- Study dates
- Mar 2015to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the diagnosis of insomnia, who come to the experts' clinic for treatment, will be invitated and included in his cohort.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites, 9 recruiting
- Not yet recruiting
East Hospital of Beijing University of Traditional Chinese Medicine
Beijing, Beijing Municipality
Rongjuan Guo
- Not yet recruiting
Guang'anmen Hospital of China Academy of China Medical Sciences
Beijing, Beijing Municipality
Ronglin Gao
- Not yet recruiting
Guang'anmen Hospital of China Academy of China Medical Sciences
Beijing, Beijing Municipality
Jiangui Zhu
- Recruiting
Guang'anmen Hospital of China Academy of China Medical Sciences
Beijing, Beijing Municipality
Yanjiao Liu
- Not yet recruiting
Fujian Institute of Traditional Chinese Medicine
Fuzhou, Fujian
Junshan Huang
- Not yet recruiting
Affiliated hospital of Shandong university of Traditional Chinese Medicine
Ji'nan, Shandong
Xianghua Qi
- Not yet recruiting
Shenzhen hospital of Traditionl Chinese Medicine
Shenzhen, Guangdong
Zhouke Guo
- Recruiting
Clinic of Hubei university of Traditional Chinese Medicine
Wuhan, Hubei
Ping Wang
- Recruiting
Affiliated hospital of He'nan university of Traditional Chinese Medicine
Zhengzhou, Henan
Songling Wang
About this study
Official title: Individualized Treatment With Traditional Chinese Medicine Pattern Differentiation for the Patients With Insomnia Disorder: a Cohort Study
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.
Read the 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.
- Being tested
- individualized treatment
- Keywords
- Insomnia, Traditional Chinese Medicine, herbal medicine, cohort study, individualized treatment, TCM pattern differentiation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: individualized treatment | |
| 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. Receives: Other: individualized treatment | |
| 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. Receives: Other: individualized treatment | |
| 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. Receives: Other: individualized treatment | |
| 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. Receives: Other: individualized treatment | |
| 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. Receives: Other: individualized treatment | |
| 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. Receives: Other: individualized treatment | |
| 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. Receives: Other: individualized treatment | |
| 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. Receives: Other: individualized treatment | |
| 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. Receives: Other: individualized treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Sleep Quality
Measured by Pittsburgh Sleep Quality Index, PSQI
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Secondary outcomes (10)
Change from baseline in the diagnosis of insomnia
Measured by the Structured Interview for Insomnia Disorder (SID), which is a translation and modified version of Brief Insomnia Questionnaire and used as a diagnosis questionnaire in the study. Its content validity has been reviewed and assessed by the experts who participated in the cohort. Three criteria of DSM-Ⅴ, ICSD-3 and ICD-10 for insomnia have been included in the SID questionnaire. The SID is chosen as an outcome to tell whether there is a diagnosis of insomnia after treatment.
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Insomnia Severity
Measured by Insomnia Severity Index, ISI
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Patient's satisfaction to the TCM treatment
Measured by the Patient's satisfaction scale
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Insomnia severity and improvement
Measured by the Clinician Global Impression Scale-Severity and -Improvement score.
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Clinician's satisfaction to the TCM treatment
Measured by the Clinician Reported Outcome for TCM treatment
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Reduction of western medicine
Reported by the patients.
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Sleep structure
Measured by the Cardiopulmonary Coupling (CPC), which is a new operator-independent, automated measure of sleep physiology. CPC collects the electrocortical activity of the heart rate variability (HRV) and respiration. The result provides information on sleep quality and sleep disordered breathing phenotypes independent of EEG analysis. High-frequency coupling states the consolidated and stable NREM sleep, and Low-frequency coupling is enhanced in states of fragmented sleep.
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Depression/Anxiety severity
Measured by the Hamilton Depression/Anxiety Scale
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Other measures that experts regard them necessary.
Other measures may include the wrist actigraphy, Polysomnography (PSG), other questionnaires, Multiple Sleep Latency Test (MSLT), CT, MRI, or some chemicals test.
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Adverse Event
Reported by the patients, such as cold, fever, diarrhea, and so on.
Measured: Week 1, 2, 4, 6, 8 or Final visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Baoyan Liu, China Academy of Chinese Medical Sciences
- Investigators
- Baoyan Liu, Master, Principal investigator, China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02402959
- Sponsor's protocol ID
- GZR81230086
- Status last verified
- Mar 2015
- First submitted
- 20 Mar 2015
- Last updated
- 31 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Treatment With Traditional Chinese Medicine Pattern Differentiation for the Patients With Insomnia Disorder: a Cohort Study
- ClinicalTrials.gov ID
- NCT02402959
- Acronym / sponsor ID
- GZR81230086
- Keywords
- Insomnia, Traditional Chinese Medicine, herbal medicine, cohort study, individualized treatment, TCM pattern differentiation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Other: individualized treatmentBased 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 | – | Other: individualized treatmentBased 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 | – | Other: individualized treatmentBased 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 | – | Other: individualized treatmentBased 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 | – | Other: individualized treatmentBased 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 | – | Other: individualized treatmentBased 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 | – | Other: individualized treatmentBased 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 | – | Other: individualized treatmentBased 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 | – | Other: individualized treatmentBased 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 | – | Other: individualized treatmentBased 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the diagnosis of insomnia, who come to the experts' clinic for treatment, will be invitated and included in his cohort.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| individualized treatmentIndividualized 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. | Other | Cohort 1, Cohort 10, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7, Cohort 8, Cohort 9 |
Primary outcome
Change from baseline in the Sleep Quality
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Measured by Pittsburgh Sleep Quality Index, PSQI
10 secondary outcomes
Change from baseline in the diagnosis of insomnia
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Insomnia Severity
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Patient's satisfaction to the TCM treatment
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Insomnia severity and improvement
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Clinician's satisfaction to the TCM treatment
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Reduction of western medicine
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Sleep structure
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Depression/Anxiety severity
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Change from baseline in the Other measures that experts regard them necessary.
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Adverse Event
Time frame: Week 1, 2, 4, 6, 8 or Final visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Baoyan Liu, Master principal investigator
China Academy of Chinese Medical Sciences
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Initiation and Maintenance Disorders, run by China Academy of Chinese Medical Sciences at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liyun He, PhD (86-010-64014411 ext. 2207, hely3699@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the Sleep Quality (time frame: Week 1, 2, 4, 6, 8 or Final visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2015.