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  • Status : Approved
    • First Submitted Date : 2017/06/22
    • Registered Date : 2017/08/09
    • Last Updated Date : 2017/07/19
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1. Background

Background Information
CRIS
Registration Number
KCT0002414 
Unique Protocol ID WKUJJ-IRB-2016-0002 
Public/Brief Title Acquisition of the tongue image data on common cold and healthy subjects 
Scientific Title Acquisition of the tongue image data on common cold and healthy subjects  
Acronym  
MFDS Regulated Study No
IND/IDE Protocol No
Registered
at Other Registry
No
Healthcare Benefit
Approval Status
 

2. Institutional Review Board/Ethics Committee

Institutional Review Board Information
Board Approval Status Submitted approval 
Board Approval Number WKUJJ-IRB-2016-0002 
Approval Date 2016-03-30 
Institutional Review Board  
Name Wonkwang University Oriental Medical Hospital Institutional Review Board 
Address  
Telephone  
Data Monitoring Committee No  

3. Contact Details

Contact Details Information
Contact Person for Principal Investigator / Scientific Queries  
Name Jong Cheon Joo 
Title Dr. 
Telephone +82-63-270-1073 
Affiliation Wonkwang University Oriental Medical Hospital, Jeonju 
Address 99, Garyeonsan-ro, Deokjin-gu, Jeonju-si, Jeollabuk-do 
Contact Person for Public Queries
Name Jihye Kim 
Title Researcher 
Telephone +82-42-868-9252 
Affiliation Korea Institute of Oriental Medicine 
Address 1672, Yuseongdae-ro, Yuseong-gu, Daejeon 
Contact Person for Updating Information
Name Jihye Kim 
Title Researcher 
Telephone +82-42-868-9252 
Affiliation Korea Institute of Oriental Medicine 
Address 1672, Yuseongdae-ro, Yuseong-gu, Daejeon 

4. Status

Status Information
Study Site Single
Overall Recruitment Status Completed  
Date of First Enrollment 2016-04-01 , Actual
Target Number of Participant 100
Primary Completion Date 2016-05-31 , Actual
Study Completion Date 2016-05-31 , Actual
Recruitment Status by Participating Study Site 1
Name of Study Site Wonkwang University Oriental Medical Hospital, Jeonju 
Recruitment Status Completed  
Date of First Enrollment 2016-04-01 , Actual

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information
Source of Monetary/Material Support 1   
Organization Name Korea Institute of Oriental Medicine 
Organization Type Others  
Project ID 37074 

6. Sponsor Organization

Sponsor Organization Information
Sponsor Organization 1   
Organization Name Korea Institute of Oriental Medicine 
Organization Type Others  

7. Study Summary

Study Summary Information
Lay Summary The aim of this study was to collect the tongue image of common cold patients and healthy subjects. The hypothesis of this study was tongue features will differ significantly between common cold patients and healthy subjects (controls group).  

8. Study Design

Study Design Information
Study Type Observational Study 
Observational Study Model Case-control 
Time Perspective Cross-sectional  
Target Number of Participant 100
Cohort/Group Number
Cohort/
Group 1
Cohort/Group
Label
Common cold patient 
Cohort/Group
Description
The common cold patients’ tongue images were taken by using a computerized tongue image analysis system. The outcomes were the changes in the tongue features including the tongue coating thickness and the tongue color captured by the computerized tongue image analysis system. Statistics experts analyzed the relationship between the results using Pearson's chi-squared test and the independent t-test.  
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  
Cohort/
Group 2
Cohort/Group
Label
Healthy subject  
Cohort/Group
Description
The healthy subjects’ tongue images were taken by using a computerized tongue image analysis system. The outcomes were the changes in the tongue features including the tongue coating thickness and the tongue color captured by the computerized tongue image analysis system. Statistics experts analyzed the relationship between the results using Pearson's chi-squared test and the independent t-test.  
Biospecimen
Collection & Archiving
Not collect nor Archive 
Biospecimen Description  

9. Subject Eligibility

Subject Eligibility Information
Study Population Description Fifty patients with common cold and fifty healthy subjects  
Sampling Method Non-probablity sampling  
Condition(s)/Problem(s) * Diseases of th respiratory system
Rare Disease No
Inclusion
Criteria
Gender Both 
Age No Limit ~ No Limit
Description ① Willing to participate and sign a written informed consent voluntarily
② are able to read, write or communicate
Patient - ③ Diagnosis of common cold according to Western medicine
Control - ④ Healthy subjects without common cold and any other disease  
Exclusion Criteria ① a history of any diseases such as influenza, acute bacterial sinusitis, allergic rhinitis, streptococcal pharyngitis and herpangina
② (a) having an organic disease, such as acute or chronic liver disease (e.g., hepatitis, liver cirrhosis), anemia, tuberculosis, chronic lung disease, cardiovascular disease (e.g., heart failure, hypertension), endocrine/metabolic disease (e.g., diabetes, thyroid gland disease, severe obesity), autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis), malignant tumors, or infectious disease; or (b) psycho-social causes, such as depression, anxiety neurosis, recent severe stress, schizophrenia, alcoholism, or an eating disorder
③ eating a food as follows: coffee, coloring ice cream which can be dyed the color of tongue coating
④ drinking alcohol within 4 hours
⑤ smoking within 1 hour
⑥ pregnancy or breast-feeding
⑦ be deemed unacceptable for participation this trial conductors  
Healthy Volunteers Yes

10. Outcome Measure(s)

Outcome Measure(s) Information
Type of Primary Outcome Not applicable 
Primary Outcome(s) 1 
Outcome Tongue coating thickness 
Timepoint Visit 2 
Secondary Outcome(s) 1 
Outcome Tongue color 
Timepoint Visit 2 

11. Study Results and Publication

Study Results and Publication Information
Result Registerd  

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

Sharing of Study Data Information
Sharing Statement Not provided at time of Registration 
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