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  • Status : Approved
    • First Submitted Date : 2018/11/21
    • Registered Date : 2019/02/11
    • Last Updated Date : 2019/07/11
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1. Background

Background Information
CRIS
Registration Number
KCT0003488 
Unique Protocol ID KHNMCOH 2018-07-002-002 
Public/Brief Title The Clinical Trial for Practical Application of Mibyeong Management Program 
Scientific Title The Clinical Trial for Practical Application of Mibyeong Management Program :a randomized controlled trial  
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 KHNMCOH 2018-07-002-002 
Approval Date 2018-09-11 
Institutional Review Board  
Name Kyung Hee University Korean Medicine Hospital at Gangdong Institutional Review Board  
Address 892, Dongnam-ro, Gangdong-gu, Seoul 
Telephone 02-440-8108 
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name min woo 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 CRC 
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 min young Park 
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 Multi-center (Number of center : 2)
Overall Recruitment Status Recruiting  
Date of First Enrollment 2018-09-28 , Actual
Target Number of Participant 150
Primary Completion Date 2019-01-19 , Actual
Study Completion Date 2019-01-31 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Kyung Hee University Oriental Medical Center 
Recruitment Status Completed  
Date of First Enrollment 2018-09-28 , Actual
Recruitment Status by Participating Study Site 2
Name of Study Site Kyung Hee University Oriental Medicine Hospital at Gangdong 
Recruitment Status Completed  
Date of First Enrollment 2018-09-28 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Ministry of Science, ICT & Future Planning 
Organization Type Government  
Project ID NRF-2014M3A9D7045482 
Source of Monetary/Material Support 2   
Organization Name Ministry of Science, ICT & Future Planning 
Organization Type Government  
Project ID NRF-2014M3A9D7034367 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
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 randomized controlled clinical trial for Practical Application of Mibyeong management program which was developed by Korea Institute of Oriental Medicine. The purpose of this study is to examine the effectiveness and practical application of Mibyeong management program by comparing and assessing changes of health awareness, health behavior, and biomarkers.

Visit 1:
Study subjects, who had satisfied both the selection and exclusion criteria, visited the research center to conduct the examination.(Evaluation criteria: (1) demographic investigation, medical history, women’s health history, health management application used or not (2) body measurement, vital signs, pulse wave, heart wave variability, body composition, face color (3) questionnaire surveying Mibyeong awareness, Health Promoting Lifestyle, Quality of Life, original symptom, Sasang constitution, chills and fever, Mibyeong(sub-health) and lifestyle (4) randomization (5) Mibyeong management program education(intervention group only) (6) expert consultation). The visit was concluded upon the completion of the above.

Visit 2:
The subjects were instructed to return to the research center in 6 weeks (±14 days) after the visit 1 (Evaluation criteria: (1) health management application used or not (2) body measurement, vital signs, pulse wave, heart wave variability, body composition, face color (3) questionnaire surveying satisfaction level with the Mibyeong manual(intervention group only), Mibyeong(sub-health) and lifestyle (4) Mibyeong management program education(intervention group only)).

Visit 3:
The subjects were instructed to return to the research center in 6 weeks (±14 days) after the visit 2 (Evaluation criteria: (1) health management application used or not (2) body measurement, vital signs, pulse wave, heart wave variability, body composition, face color (3) questionnaire surveying satisfaction level with the Mibyeong manual(intervention group only), Mibyeong awareness, Health Promoting Lifestyle, Quality of Life, chills and fever, Mibyeong(sub-health) and lifestyle (4)Mibyeong management program education(waitlist group only) (5) expert consultation). After the visit 3, all research schedules are completed.  

8. Study Design

Study Design Information
Study Type Interventional Study 
Study Purpose Others (to examine the effectiveness and practical application of Mibyeong management program)  
Phase Not applicable 
Intervention Model Parallel  
Blinding/Masking Open 
Allocation RCT 
Intervention Type Others  
Intervention Description Intervention group: The Intervention group does daily life using Mibyeong management program.
The ratio of the number of access to Mibyeong management program application(once per day) is calculated as percentage(%). Total compliance during intervention period should be at least 70%, and if it is less than 70%, it is excluded from per-protocol group.
Waitlist group: The control group maintains daily life without using Mibyeong management program.  
Number of Arms
Arm 1 Arm Label Intervention group 
Target Number of Participant 75 
Arm Type Experimental 
Arm Description The Intervention group does daily life using Mibyeong management program. The ratio of the number of access to Mibyeong management program application(once per day) is calculated as percentage(%). Total compliance during intervention period should be at least 70%, and if it is less than 70%, it is excluded from per-protocol group. 
Arm 2 Arm Label Control group 
Target Number of Participant 75 
Arm Type No intervention 
Arm Description The control group maintains daily life without using Mibyeong management program. 

9. Subject Eligibility

Subject Eligibility Information
Condition(s) / Problem(s) * Symptoms, signs and abnormal clinical and laboratory findings, NEC
 men and women between the ages of 30-49 years who are able to participate independently in evaluation/ survey required in the present research
Rare Disease No
Inclusion
Criteria
Gender Both 
Age 30 Year ~ 49 Year
Description (1) men and women between the ages of 30-49 years
(2) able to use smartphone
(3) able to participate for 3 months as subjects of the present research
(4) able to participate independently in evaluation/ survey required in the present research
(5) a person who has voluntarily decided to participate in the present research and received written consent  
Exclusion Criteria (1) a person who does not have a smartphone(Android 4.4 or IOS 9 and over version)
(2) a person who participated in internet mediation or clinical trials in the last 1 month.
(3) other individuals deemed ill-suited for participation in the present research by the principal researcher due to clinically significant medical or psychiatric finding (e.g., cardio-cerebrovascular disease, malignant neoplasm, pregnant woman, etc.)  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Not applicable 
Primary Outcome(s) 1 
Outcome Mibyeong awareness 
Timepoint Visit 1, 3 
Secondary Outcome(s) 1 
Outcome Health promoting behaviors 
Timepoint Visit 1, 2, 3 
Secondary Outcome(s) 2 
Outcome biomarker change(blood pressure, pulse wave, heart wave variability, body composition) 
Timepoint Visit 1, 2, 3 
Secondary Outcome(s) 3 
Outcome Subjective health status(Mibyeong(sub-health),Quality of Life) 
Timepoint Visit 1, 2, 3 
Secondary Outcome(s) 4 
Outcome satisfaction level with the application 
Timepoint Visit 1, 2, 3 
Secondary Outcome(s) 5 
Outcome number of days of access Mibyeong management program 
Timepoint Visit 1, 2, 3 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd No

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

Sharing of Study Data Information
Sharing Statement No 
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