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Retrospective chart review and analysis of facial palsy patients treated by Western medicine and Korean traditional medicine collaboration

Status Approved

First Submitted Date

2017/03/21
Registered Date

2017/04/18
Last Updated Date

2017/04/01

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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	KCT0002312
Unique Protocol ID	WMCSB 201702-14
Public/Brief Title	Retrospective chart review and analysis of facial palsy patients treated by Western medicine and Korean traditional medicine collaboration
Scientific Title	Retrospective chart review and analysis of facial palsy patients treated by Western medicine and Korean traditional medicine collaboration
Acronym
MFDS Regulated Study	No
IND/IDE Protocol
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	WMCSB 201702-14
Approval Date	2017-02-16
Institutional Review Board Name	Wonkwang University Sanbon Hospital IRB
Institutional Review Board Address
Institutional Review Board Telephone
Data Monitoring Committee

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	Hyungwon Kang
Title	Professor
Telephone	+82-31-390-2763
Affiliation	Wonkwang University Sanbon Hospital
Address	321, Sanbon-ro, Gunpo-si, Gyeonggi-do, 15865, Rep. of KOREA
Contact Person for Public Queries
Name	Nam-Kuon Kim
Title	Professor
Telephone	+82-55-360-5947
Affiliation	Pusan National University
Address	2, Busandaehak-ro 63beon-gil, Geumjeong-gu, Busan, 46241, Rep. of KOREA
Contact Person for Updating Information
Name	Haegue Shin
Title	Student
Telephone	+82-63-850-6984
Affiliation	Wonkwang University
Address	460, Iksan-daero, Iksan-si, Jeollabuk-do, 54538, Rep. 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	Active, not recruiting
Date of First Enrollment	2017-03-21 Actual
Target Number of Participant	18
Primary Completion Date	2017-06-31 , Anticipated
Study Completion Date	2017-06-30 , Anticipated
Name of Study	Wonkwang University Sanbon Hospital
Recruitment Status	Active, not recruiting
Date of First Enrollment	2017-03-21 ,

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	National Research Foundation
Organization Type	Research Institute
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Wonkwang University Sanbon Hospital
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	This study analyses the clinical pathway of facial palsy patients over 19 years old who visited Western medicine and Korean traditional medicine collaborated hospital by retrospective collection of medical records and computer data on the Real world basis. It further compares and analyses the validity of the clinical pathway drawn from the big data from Health Insurance Review and Assessment Service.

Study Summary Information

Lay Summary

This study analyses the clinical pathway of facial palsy patients over 19 years old who visited Western medicine and Korean traditional medicine collaborated hospital by retrospective collection of medical records and computer data on the Real world basis. It further compares and analyses the validity of the clinical pathway drawn from the big data from Health Insurance Review and Assessment Service.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Cohort
Time Perspective	Retrospective
Target Number of Participant	18
Cohort/Group Number	1
Cohort/ Group 1	Cohort/Group Label Facial palsy patients over nineteen years old treated by Western medicine and Korean traditional medicine collaboration
Cohort/ Group 1	Cohort/Group Description Clinical pathway and patterns of facial palsy patients over nineteen years old treated by Western medicine and Korean traditional medicine collaboration in this hospital from January 1, 2016 to December 31, 2016 (for 5 months) whose medical recording code are G510, G511, G512, G513, G514, G518, G519, G530, G531, G532, G533, or G538
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Facial palsy patients over nineteen years old treated by Western medicine and Korean traditional medicine collaboration in this hospital from January 1, 2016 to December 31, 2016 (for 5 months) whose medical recording code are G510, G511, G512, G513, G514, G518, G519, G530, G531, G532, G533, or G538
Sampling Method	Retrospective collection of medical records and computer data of facial palsy patients over nineteen years old treated by Western medicine and Korean traditional medicine collaboration in this hospital from January 1, 2016 to December 31, 2016 (for 5 months)
Condition(s)/Problem(s)	* (G00-G99)Diseases of the nervous system (G51.0)Bell’s palsy
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description Facial paralysis patients over nineteen years old treated by Western medicine and Korean traditional medicine collaboration in this hospital from January 1, 2016 to December 31, 2016 (for 5 months) whose medical recording code are G510, G511, G512, G513, G514, G518, G519, G530, G531, G532, G533, or G538
Exclusion Criteria	None
Healthy Volunteers	No

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	Clinical pathway of facial palsy patients
Timepoint	Beginning of the study
Secondary Outcome(s) 1
Outcome	Sociodemographic variable
Timepoint	Beginning of the study

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

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	Not provided at time of Registration

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