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A Pilot Study of Clinical Application of Mibyeong Management Program

Status Approved

First Submitted Date

2018/02/27
Registered Date

2018/04/23
Last Updated Date

2018/07/30

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0002822
Unique Protocol ID	KHNMCOH2017-12-002-001
Public/Brief Title	A Pilot Study of Clinical Application of Mibyeong Management Program
Scientific Title	A Pilot Study of Clinical Application of Mibyeong Management Program
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KHNMCOH2017-12-002-001
Approval Date	2018-01-30
Institutional Review Board Name	Kyung Hee University Korean Medicine Hospital at Gangdong Institutional Review Board
Institutional Review Board Address	892, Dongnam-ro, Gangdong-gu, Seoul
Institutional Review Board Telephone	02-440-8108
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	min yoo Hwang
Title	associate professor
Telephone	+82-2-440-7289
Affiliation	Kyung Hee University
Address	26, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	hye eun Na
Title	Clinical Research Co
Telephone	+82-2-440-7289
Affiliation	Kyung Hee University
Address	26, Kyungheedae-ro, Dongdaemun-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	hyun joo Oh
Title	resident
Telephone	+82-2-440-7290
Affiliation	Kyung Hee University Oriental Medicine Hospital at Gangdong
Address	892, Dongnam-ro, Gangdong-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Completed
Date of First Enrollment	2018-02-05 Actual
Target Number of Participant	30
Primary Completion Date	2018-03-17 , Actual
Study Completion Date	2018-04-25 , Actual
Name of Study	Kyung Hee University Oriental Medicine Hospital at Gangdong
Recruitment Status	Completed
Date of First Enrollment	2018-02-05 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Ministry of Science, ICT & Future Planning
Organization Type	Government
Project ID	2014M 3A9D 7045482

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyung Hee University Oriental Medicine Hospital at Gangdong
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study is a pilot study of clinical application of Mibyeong management program which was developed by Korea Institute of Oriental Medicine. The purpose of this study is to collect data for clinical application and program supplementation of the developed Mibyeong management program. Study subjects, who had satisfied both the selection and exclusion criteria, visited the research center to conduct the examination.(Evaluation criteria: (1)body measurement, vital signs, pulse wave, heart wave variability, body composition (2)questionnaire surveying exercise/physical activity, medical history, women’s health history, Quality of Life, Sasang constitution, chills and fever, Mibyeong(sub-health), lifestyle (3) expert consultation). The visit was concluded upon the completion of the above. Within two weeks(±5 days) after the first visit, the subjects were instructed to conduct questionnaire surveying chills and fever, Mibyeong(sub-health) through the developed Mibyeong management program by themselves. The subjects were instructed to return to the research center in 4 weeks (±1 weeks) for a second round of evaluation (Evaluation criteria: (1) body measurement, vital signs, pulse wave, heart wave variability, body composition (2)questionnaire surveying Quality of Life, chills and fever, Mibyeong(sub-health), lifestyle, satisfaction level with the Mibyeong manual (3) expert consultation). The second visit was concluded upon the completion of the above.

Study Summary Information

Lay Summary

This study is a pilot study of clinical application of Mibyeong management program which was developed by Korea Institute of Oriental Medicine. The purpose of this study is to collect data for clinical application and program supplementation of the developed Mibyeong management program. 
Study subjects, who had satisfied both the selection and exclusion criteria, visited the research center to conduct the examination.(Evaluation criteria: (1)body measurement, vital signs, pulse wave, heart wave variability, body composition (2)questionnaire surveying exercise/physical activity, medical history, women’s health history, Quality of Life, Sasang constitution, chills and fever,  Mibyeong(sub-health), lifestyle (3) expert consultation). The visit was concluded upon the completion of the above. 
Within two weeks(±5 days) after the first visit, the subjects were instructed to conduct questionnaire surveying chills and fever, Mibyeong(sub-health) through the developed Mibyeong management program by themselves.
The subjects were instructed to return to the research center in 4 weeks (±1 weeks) for a second round of evaluation (Evaluation criteria: (1) body measurement, vital signs, pulse wave, heart wave variability, body composition (2)questionnaire surveying  Quality of Life, chills and fever,  Mibyeong(sub-health), lifestyle, satisfaction level with the Mibyeong manual (3) expert consultation). The second visit was concluded upon the completion of the above.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Others (To collect data for clinical application and program supplementation of the developed Mibyeong management program)
Phase	Not applicable
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Others
Intervention Description	application of Mibyeong management program according to the needs of participants
Number of Arms	1
Arm 1	Arm Label men and women between the ages of 30-49 years
	Target Number of Participant 30
	Arm Type Experimental
	Arm Description Study subjects visited the research center to conduct the examination.(Evaluation criteria: (1)body measurement, vital signs, pulse wave, heart wave variability, body composition (2)questionnaire surveying exercise/physical activity, medical history, women’s health history, Quality of Life, Sasang constitution, chills and fever, Mibyeong(sub-health), lifestyle (3) expert consultation). The visit was concluded upon the completion of the above. Within two weeks(±5 days) after the first visit, the subjects were instructed to conduct questionnaire surveying chills and fever, Mibyeong(sub-health) through the developed Mibyeong management program by themselves. The subjects were instructed to return to the research center in 4 weeks (±1 weeks) for a second round of evaluation (Evaluation criteria: (1) body measurement, vital signs, pulse wave, heart wave variability, body composition (2)questionnaire surveying Quality of Life, chills and fever, Mibyeong(sub-health), lifestyle, satisfaction level with the Mibyeong manual (3) expert consultation). The second visit was concluded upon the completion of the above.

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	Not Applicable-Quality of life
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 30Year~49Year
	Description (1) a person who has voluntarily decided to participate in the present research and received written consent (2) men and women between the ages of 30-49 years (3) able to participate independently in evaluation/ survey required in the present research (4) able to follow up to 5 weeks as subjects of the present research
Exclusion Criteria	(1) other individuals deemed ill-suited for participation in the present research by the principal researcher due to clinically significant medical or psychiatric finding
Healthy Volunteers	Yes

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	questionnaire(satisfaction level with the Mibyeong program)
Timepoint	Visit2
Secondary Outcome(s) 1
Outcome	machine measurement(pulse wave)
Timepoint	Visit 1,2
Secondary Outcome(s) 2
Outcome	machine measurement(heart wave variability)
Timepoint	Visit 1,2
Secondary Outcome(s) 3
Outcome	machine measurement(body composition)
Timepoint	Visit 1,2
Secondary Outcome(s) 4
Outcome	questionnaire(Mibyeong(sub-health))
Timepoint	Visit1, Web survey1, Visit2
Secondary Outcome(s) 5
Outcome	questionnaire(chills and fever)
Timepoint	Visit1, Web survey1, Visit2
Secondary Outcome(s) 6
Outcome	questionnaire(quality of life)
Timepoint	Visit 1,2

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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