- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03640169
Development of Health Management Model for Chinese Medical Preventive Medicine
Evaluation Project for the Development of Health Management Model for Chinese Medical Preventive Medicine
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
With regard to "Developing traditional Chinese medicine (TCM) Health Care", the goal of "Promoting the development of TCM health promotion service" was set and the strategy of "Promoting the development of TCM preventive medicine and health promotion services" was used to develop TCM preventive medicine, which is applied to preventing disease and improving physical fitness. By establishing the TCM health care prototype of "health promotion" and "preventive medicine," this project will push the systemic development of TCM preventive medicine forward and improve suboptimal health by early intervention, providing people with multiple model choices in self-health management.
This project will first form a multidisciplinary team to gather and analyze the domestic and international health promotion and management models of TCM or traditional medicine. Then systematically arrange and induct the literature references to establish the outline and draft of "Health management model of TCM preventive medicine." Furthermore, in July-September, this project will try to practice "Health management model of TCM preventive medicine" together with health promotion groups related to Taiwan Society of Health Promotion in the district of Shilin and Zhongzheng in Taipei city, and plan to recruit 100 people. The purpose of this project is to design a health management model of TCM preventive medicine that meets the need of healthy or suboptimal healthy people. The investigators expecte to bring out the prototype of "Health management model of TCM preventive medicine" and finish the follow-up promoting proposal of the draft in the meantime, which will discuss the possibility of applying this model to healthy or suboptimal healthy people and bring up concrete policy and implementation recommendations of "promoting the development of TCM preventive medicine and health promotion services."
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Taipei, Taiwan, 106
- Taiwan Society of Health Promotion
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- more than 20 y/o.
- can walk independently, without disability
- can communicate with Chinese or Taiwanese, and understand the purpose of the study
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Management of TCM preventive medicine
The Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Duo-in qigong practice.
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The Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Duo-in qigong practice.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood pressure
Time Frame: Change from baseline of both systolic and diastolic pressure at 8 week
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Change of both systolic and diastolic pressure after 8 week
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Change from baseline of both systolic and diastolic pressure at 8 week
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Heart rate variability
Time Frame: Change from Baseline Heart rate variability at 8 week
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Change of Heart rate variability after 8 week
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Change from Baseline Heart rate variability at 8 week
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Blood oxygen concentration
Time Frame: Change from Baseline Blood oxygen concentration at 8 week
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Change of Blood oxygen concentration after 8 week
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Change from Baseline Blood oxygen concentration at 8 week
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Pressure index
Time Frame: Change from Baseline score of Pressure index at 8 week
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Change of the pressure feeling after 8 week.
Score ranged from 0-12: the higher the score, the heavy the pressure feeling.
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Change from Baseline score of Pressure index at 8 week
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Body Constitution Scores (measured by Body Constitution Questionnaire, BCQ)
Time Frame: Change from Baseline Body Constitution Yang- deficiency, Yin- deficiency and Stasis Scores at 8 week
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The measurement of Body Constitution Questionnaire will come out 3 scores: Scores of Yang-deficiency: ranged from 19-95 Score of Yin- deficiency: ranged from 19-95 Score of Stasis: ranged from 16-80 The higher the score, the worse the Yang- deficiency, Yin- deficiency and Stasis. |
Change from Baseline Body Constitution Yang- deficiency, Yin- deficiency and Stasis Scores at 8 week
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Heart rate
Time Frame: Change from Baseline Heart rate at 8 week
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Change of Heart rate after 8 week
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Change from Baseline Heart rate at 8 week
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Pittsburgh Sleep Quality Index
Time Frame: Change from Baseline total score of Pittsburgh Sleep Quality Index at 8 week
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Change of the global score of Pittsburgh Sleep Quality Index after 8 week The higher the global score, the worse the sleep quality.
If the global <=5, defined to have good sleep quality; If the global > 5, defined to have bad sleep quality.
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Change from Baseline total score of Pittsburgh Sleep Quality Index at 8 week
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Brief Symptom Rating Scale(BSRS-5)
Time Frame: Change from Baseline BSRS-5 at 8 week
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Change of the score of the Brief Symptom Rating Scale after 8 week.
Score ranged from 0-24: the higher the score the worse the physical and mental condition.
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Change from Baseline BSRS-5 at 8 week
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Dietary behavior Instrument
Time Frame: Change from Baseline total score of the Dietary behavior Instrument at 8 week
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Change of score of the Dietary behavior Instrument after 8 week.
Score ranged from 0-36: the higher the score, the better the eating behavior.
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Change from Baseline total score of the Dietary behavior Instrument at 8 week
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CMUH106-REC1-082
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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