Preventive MedicineNCT03640182
Promotion Project of Health Management Model for Chinese Medical Preventive Medicine
A study testing Health management model of TCM preventive medicine in people with Preventive Medicine and Health Promotion, run by China Medical University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Preventive Medicine, Health Promotion
- What is being tested?
- Health management model of TCM preventive medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jul 2018to 8 Sep 2018
- Phase
- Interventional
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- more than 20 y/o.
- can walk independently, without disability
- can communicate with Chinese or Taiwanese, and understand the purpose of the study
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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."
- Conditions
- Preventive Medicine, Health Promotion
- Being tested
- Health management model of TCM preventive medicine
- Keywords
- Health Management Model, Chinese Medicine, Preventive Medicine, Body Constitution, Health Promotion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health management model of TCM preventive medicineOther
The Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Medical Ba-Duan-Jin duo-in qigong practice.
| Study group | Role | What they receive |
|---|---|---|
| Management of TCM preventive medicine | Experimental | The Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Medical Ba-Duan-Jin duo-in qigong practice. Receives: Other: Health management model of TCM preventive medicine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline Body Constitution Yang- deficiency, Yin- deficiency and Stasis Scores at 8 week
Blood pressure
Change of both systolic and diastolic pressure after 8 week
Measured: Change from baseline of both systolic and diastolic pressure at 8 week
heart rate
Change of heart rate after 8 week
Measured: Change from Baseline Heart rate at 8 week
Heart rate variability
Change of Heart rate variability after 8 week
Measured: Change from Baseline Heart rate variability at 8 week
Blood oxygen concentration
Change of Blood oxygen concentration after 8 week
Measured: Change from Baseline Blood oxygen concentration at 8 week
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.
Measured: Change from Baseline global score of Pittsburgh Sleep Quality Index at 8 week
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.
Measured: Change from Baseline score of Brief Symptom Rating Scale at 8 week
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.
Measured: Change from Baseline score of the Dietary behavior Instrument at 8 week
Pressure index
Change of the pressure feeling after 8 week. Score ranged from 0-12: the higher the score, the heavy the pressure feeling.
Measured: Change from Baseline score of Pressure index at 8 week
2.44 meter stand-up test
Change of the stand-up and walking ability after 8 week
Measured: Change from Baseline 2.44 meter stand-up test at 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start2 Jul 2018
- Primary completion3 Sep 2018 (estimated)
- Study completion8 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preventive MedicineStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University, China, Tri-Service General Hospital (TSGH), Taiwan Society of Health Promotion, National Research Institute of Chinese Medicine, Ministry of Health and Welfare, National Yang Ming Chiao Tung University, University of Taipei, Taipei Veterans General Hospital, Taiwan
- Responsible party
- Principal investigator, Yi-Chang Su, China Medical University, China
- Investigators
- Yi-Chang Su, PhD, Principal investigator, China Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640182
- Sponsor's protocol ID
- CMUH107-REC1-008
- Status last verified
- Aug 2018
- First submitted
- 20 Jul 2018
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promotion Project of Health Management Model for Chinese Medical Preventive Medicine
- ClinicalTrials.gov ID
- NCT03640182
- Acronym / sponsor ID
- CMUH107-REC1-008
- Conditions
- Preventive Medicine, Health Promotion
- Keywords
- Health Management Model, Chinese Medicine, Preventive Medicine, Body Constitution, Health Promotion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- China Medical University, China, Tri-Service General Hospital (TSGH), Taiwan Society of Health Promotion, National Research Institute of Chinese Medicine, Ministry of Health and Welfare, National Yang Ming Chiao Tung University, University of Taipei, Taipei Veterans General Hospital, Taiwan
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 3 Sep 2018 (estimated)
- Study completion
- 8 Sep 2018 (estimated)
- First posted
- 21 Aug 2018 (actual)
- 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 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.
Detailed 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."
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Management of TCM preventive medicine | Experimental | Other: Health management model of TCM preventive medicineThe Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Medical Ba-Duan-Jin duo-in qigong practice. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- more than 20 y/o.
- can walk independently, without disability
- can communicate with Chinese or Taiwanese, and understand the purpose of the study
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Health management model of TCM preventive medicineThe Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Medical Ba-Duan-Jin duo-in qigong practice. | Other | Management of TCM preventive medicine |
Primary outcome
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, Ying- deficiency and Stasis. BCQ measure
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
heart rate
Time frame: Change from Baseline Heart rate at 8 week
Change of heart rate after 8 week
Heart rate variability
Time frame: Change from Baseline Heart rate variability at 8 week
Change of Heart rate variability after 8 week
Blood oxygen concentration
Time frame: Change from Baseline Blood oxygen concentration at 8 week
Change of Blood oxygen concentration after 8 week
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from Baseline global 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.
Brief Symptom Rating Scale（BSRS-5）
Time frame: Change from Baseline score of Brief Symptom Rating Scale at 8 week
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.
Dietary behavior Instrument
Time frame: Change from Baseline score of the Dietary behavior Instrument at 8 week
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.
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.
2.44 meter stand-up test
Time frame: Change from Baseline 2.44 meter stand-up test at 8 week
Change of the stand-up and walking ability after 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Yi-Chang Su, PhD principal investigator
China Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health management model of TCM preventive medicine in people with Preventive Medicine and Health Promotion, run by China Medical University Hospital at 1 site in Taiwan.
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 1 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 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 10 primary outcomes in all. 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 24 Aug 2018.