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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03640182
Other study ID # CMUH107-REC1-008
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date July 2, 2018
Est. completion date September 8, 2018

Study information

Verified date August 2018
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this project is to design a health management model of traditional Chinese medicine (TCM) preventive medicine that meets the need of 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." 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, Zhongzheng, Beitou, and Songshan in Taipei city, and plan to recruit 200 people in this promotion project.


Description:

As population aging and fast-paced lifestyle go on, chronic diseases increase rapidly and preventive medicine has become the key point of science in modern days. In addition, World Health Assembly urged member states to appropriately integrate traditional and complementary medicine into health services according to the resolutions of sixty-ninth World Health Assembly.(WHA69.24). To strengthen the foresight of health and welfare governance, Ministry of Health and Welfare lay down "2025 White Paper on Health and Welfare Policy", looking on ahead the needs of health care, preventive care, health promotion and social welfare.

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, proving 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, 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, Zhongzheng, Beitou, and Songshan in Taipei city, and plan to recruit 200 people in this promotion project. 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 and bring up concrete policy and implementation recommendations of "promoting the development of TCM preventive medicine and health promotion services."


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 200
Est. completion date September 8, 2018
Est. primary completion date September 3, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Health management model of TCM preventive medicine
The Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Medical Ba-Duan-Jin duo-in qigong practice.

Locations

Country Name City State
Taiwan Taiwan Society of Health Promotion Taipei

Sponsors (8)

Lead Sponsor Collaborator
China Medical University Hospital China Medical University, China, National Research Institute of Chinese Medicine, Ministry of Health and Welfare, National Yang Ming University, Taipei Veterans General Hospital, Taiwan, Taiwan Society of Health Promotion, Tri-Service General Hospital, University of Taipei

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Body Constitution Scores (measured by Body Constitution Questionnaire, BCQ) 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, Ying- deficiency and Stasis.
BCQ measure
Change from Baseline Body Constitution Yang- deficiency, Yin- deficiency and Stasis Scores at 8 week
Primary Blood pressure Change of both systolic and diastolic pressure after 8 week Change from baseline of both systolic and diastolic pressure at 8 week
Primary heart rate Change of heart rate after 8 week Change from Baseline Heart rate at 8 week
Primary Heart rate variability Change of Heart rate variability after 8 week Change from Baseline Heart rate variability at 8 week
Primary Blood oxygen concentration Change of Blood oxygen concentration after 8 week Change from Baseline Blood oxygen concentration at 8 week
Primary Pittsburgh Sleep Quality Index (PSQI) 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. Change from Baseline global score of Pittsburgh Sleep Quality Index at 8 week
Primary Brief Symptom Rating Scale(BSRS-5) Change of the total 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. Change from Baseline score of Brief Symptom Rating Scale at 8 week
Primary Dietary behavior Instrument Change of total score of the Dietary behavior Instrument after 8 week. Score ranged from 0-36: the higher the score, the better the eating behavior. Change from Baseline score of the Dietary behavior Instrument at 8 week
Primary Pressure index Change of the pressure feeling after 8 week. Score ranged from 0-12: the higher the score, the heavy the pressure feeling. Change from Baseline score of Pressure index at 8 week
Primary 2.44 meter stand-up test Change of the stand-up and walking ability after 8 week Change from Baseline 2.44 meter stand-up test at 8 week
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