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Individualized Treatment With Traditional Chinese Medicine for the Patients With Insomnia Disorder: a Cohort Study

NCT ID: NCT02402959

Last Updated: 2015-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-02-29

Brief Summary

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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

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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.

Conditions

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Sleep Initiation and Maintenance Disorders

Keywords

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Insomnia Traditional Chinese Medicine herbal medicine cohort study individualized treatment TCM pattern differentiation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

individualized treatment

Intervention Type OTHER

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.

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.

individualized treatment

Intervention Type OTHER

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.

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.

individualized treatment

Intervention Type OTHER

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.

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.

individualized treatment

Intervention Type OTHER

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.

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.

individualized treatment

Intervention Type OTHER

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.

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.

individualized treatment

Intervention Type OTHER

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.

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.

individualized treatment

Intervention Type OTHER

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.

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.

individualized treatment

Intervention Type OTHER

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.

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.

individualized treatment

Intervention Type OTHER

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.

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.

individualized treatment

Intervention Type OTHER

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.

Interventions

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individualized treatment

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Natural Science Foundation of China

OTHER_GOV

Sponsor Role collaborator

China Academy of Chinese Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Baoyan Liu

vice-president

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Baoyan Liu, Master

Role: PRINCIPAL_INVESTIGATOR

China Academy of Chinese Medical Sciences

Locations

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East Hospital of Beijing University of Traditional Chinese Medicine

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Guang'anmen Hospital of China Academy of China Medical Sciences

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Guang'anmen Hospital of China Academy of China Medical Sciences

Beijing, Beijing Municipality, China

Site Status NOT_YET_RECRUITING

Guang'anmen Hospital of China Academy of China Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Fujian Institute of Traditional Chinese Medicine

Fuzhou, Fujian, China

Site Status NOT_YET_RECRUITING

Shenzhen hospital of Traditionl Chinese Medicine

Shenzhen, Guangdong, China

Site Status NOT_YET_RECRUITING

Affiliated hospital of He'nan university of Traditional Chinese Medicine

Zhengzhou, Henan, China

Site Status RECRUITING

Clinic of Hubei university of Traditional Chinese Medicine

Wuhan, Hubei, China

Site Status RECRUITING

Affiliated hospital of Shandong university of Traditional Chinese Medicine

Ji'nan, Shandong, China

Site Status NOT_YET_RECRUITING

Countries

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China

Central Contacts

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Liyun He, PhD

Role: CONTACT

Phone: 86-010-64014411

Email: [email protected]

Changhe Yu, Master

Role: CONTACT

Phone: 86-010-64014411

Email: [email protected]

Facility Contacts

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Rongjuan Guo

Role: primary

Ronglin Gao

Role: primary

Jiangui Zhu

Role: primary

Yanjiao Liu

Role: primary

Junshan Huang

Role: primary

Zhouke Guo

Role: primary

Songling Wang

Role: primary

Ping Wang

Role: primary

Xianghua Qi

Role: primary

Other Identifiers

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GZR81230086

Identifier Type: -

Identifier Source: org_study_id