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Development of Health Management Model for Chinese Medical Preventive Medicine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03640169
Recruitment Status : Completed
First Posted : August 21, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborators:
China Medical University, China
Tri-Service General Hospital
Taiwan Society of Health Promotion
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
National Yang Ming University
Taipei Veterans General Hospital, Taiwan
Information provided by (Responsible Party):
Yi-Chang Su, China Medical University, China

Study Description
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Brief Summary:
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. 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.

Condition or disease Intervention/treatment Phase
Preventive Medicine Health Promotion Other: Health management of TCM preventive medicine Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Evaluation Project for the Development of Health Management Model for Chinese Medical Preventive Medicine
Actual Study Start Date : July 7, 2017
Actual Primary Completion Date : September 16, 2017
Actual Study Completion Date : September 16, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines

Arms and Interventions
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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.
 Other: Health 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

    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.


  2. Blood pressure [ Time Frame: Change from baseline of both systolic and diastolic pressure at 8 week ]
    Change of both systolic and diastolic pressure after 8 week

  3. Heart rate [ Time Frame: Change from Baseline Heart rate at 8 week ]
    Change of Heart rate after 8 week

  4. Heart rate variability [ Time Frame: Change from Baseline Heart rate variability at 8 week ]
    Change of Heart rate variability after 8 week

  5. Blood oxygen concentration [ Time Frame: Change from Baseline Blood oxygen concentration at 8 week ]
    Change of Blood oxygen concentration after 8 week

  6. Pittsburgh Sleep Quality Index [ Time Frame: Change from Baseline total score of Pittsburgh Sleep Quality Index at 8 week ]
    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.

  7. Brief Symptom Rating Scale（BSRS-5） [ Time Frame: Change from Baseline BSRS-5 at 8 week ]
    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.

  8. Dietary behavior Instrument [ Time Frame: Change from Baseline total score of the Dietary behavior Instrument at 8 week ]
    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.

  9. Pressure index [ Time Frame: Change from Baseline score of Pressure index at 8 week ]
    Change of the pressure feeling after 8 week. Score ranged from 0-12: the higher the score, the heavy the pressure feeling.


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640169


Locations
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Taiwan
Taiwan Society of Health Promotion
Taipei, Taiwan, 106
Sponsors and Collaborators
China Medical University Hospital
China Medical University, China
Tri-Service General Hospital
Taiwan Society of Health Promotion
National Research Institute of Chinese Medicine, Ministry of Health and Welfare
National Yang Ming University
Taipei Veterans General Hospital, Taiwan
Investigators
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Principal Investigator: Yi-Chang Su, PhD China Medical University, China
More Information
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Responsible Party: Yi-Chang Su, Professor, China Medical University, China
ClinicalTrials.gov Identifier: NCT03640169    
Other Study ID Numbers: CMUH106-REC1-082
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yi-Chang Su, China Medical University, China:
Health Management Model
Chinese Medicine
Preventive Medicine
Body Constitution
Health Promotion