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A clinical study on menstrual pain investigating the effectiveness of an integrated diagnostic system combining typology, complexion, pulse, and symptoms

Status Approved

  • First Submitted Date

    2016/05/19

  • Registered Date

    2016/05/24

  • Last Updated Date

    2017/10/20

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    		 KCT0001929
    Unique Protocol ID 2014-07
    Public/Brief Title Research for the Effectiveness of the Integrated Diagnostic System for Typology, Complexion, Pulse, and Symptoms
    Scientific Title A clinical study on menstrual pain investigating the effectiveness of an integrated diagnostic system combining typology, complexion, pulse, and symptoms
    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 2014-07
    Approval Date 2014-10-08
    Institutional Review Board Name DONG-EUI University Korean Medical Hospital Institutional Review Board
    Institutional Review Board Address
    Institutional Review Board Telephone
    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 In Seon Lee
    Title professor
    Telephone +82-51-850-8660
    Affiliation Dong-Eui University Oriental Medicine Hospital
    Address 62, Yangjeong-ro, Busanjin-gu, Busan
    Contact Person for Public Queries
    Name Soo Hyung Jeon
    Title assistant professor
    Telephone +82-51-850-8904
    Affiliation Dong-Eui University Oriental Medicine Hospital
    Address 62, Yangjeong-ro, Busanjin-gu, Busan
    Contact Person for Updating Information
    Name Soo Hyung Jeon
    Title assistant professor
    Telephone +82-51-850-8904
    Affiliation Dong-Eui University Oriental Medicine Hospital
    Address 62, Yangjeong-ro, Busanjin-gu, Busan

  • 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
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2014-11-21 Actual
    Target Number of Participant 1026
    Primary Completion Date 2016-06-25 , Actual
    Study Completion Date 2016-07-27 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Dong-Eui University Oriental Medicine Hospital
    Recruitment Status Completed
    Date of First Enrollment 2014-11-21 ,

  • 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 Ministry of Health & Welfare
    Organization Type Government
    Project ID HI14D1103

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Dong-Eui University Oriental Medicine Hospital
    Organization Type Medical Institute

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    In order to perform an integrated diagnosis in traditional Korean medicine (TKM), information is collected on diagnostic variables like typology, complexion, pulse, and physiological symptoms. To reduce subjective diagnoses and inconsistencies between individual practitioners, equipment for data collection and statistical analysis are needed. An integrated diagnostic system based on the variables of typology, complexion, pulse and symptoms is able to collect objective data and provide output by means of a 3-dimensional facial shape diagnostic system, 3-dimensional pulse wave analyzer, and the Diagnosis System of Oriental Medicine (DSOM).
This study aimed to analyze the correlation between data of typology, complexion, pulse and symptoms in two groups of females over 18 assigned to a menstrual pain group and a comparison group.

  • 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 Case-control
    Time Perspective Cross-sectional  
    Target Number of Participant 1026
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    experimental group

    Cohort/Group Description

    The experimental group was composed of subjects who experience discomfort in daily life or interpersonal activities caused by menstrual pain, with scores of 4 or above on the Measure of Menstrual Pain(MMP).
To obtain facial image scan data, we used a 3-dimensional face shape diagnostic system. 
To collect data on subjects’ pulse waves, we used a 3-dimensional blood pressure pulse analyzer (3D MAC: Daeyomedi, Korea).
To collect data on subjects’ symptoms, we used the Diagnosis System of Oriental Medicine (DSOM).
    Cohort/
    Group 2

    Cohort/Group Label

    Control group

    Cohort/Group Description

    The control group was composed of subjects reporting little or no discomfort caused by menstrual pain in daily life or interpersonal activities, with scores of 3 or below on the Measure of Menstrual Pain(MMP).
To obtain facial image scan data, we used a 3-dimensional face shape diagnostic system. 
To collect data on subjects’ pulse waves, we used a 3-dimensional blood pressure pulse analyzer (3D MAC: Daeyomedi, Korea).
To collect data on subjects’ symptoms, we used the Diagnosis System of Oriental Medicine (DSOM).
    Biospecimen
    Collection & Archiving    		 
    Not collect nor Archive
    Biospecimen Description 
    		
												
    
											    
										
    
									
									
								
							
    
						
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									9. Subject Eligibility
								
    
								
							
    
							
    
								
    
									Subject Eligibility Information
									
										
											
    
												Study Population Description
												
    females aged 18 or above and residing in the city of “B,” in the Republic of Korea
    		
											
    
											
    
												Sampling Method
												
    • Explain the purpose of this study to the subjects who participated through the clinical trial recruitment announcement
• Classify them into menstrual pain group and control group according to results of menstrual cycle questionnaire
• Each recruit 513 people
• Non-probablity sampling
    		
											
    
										
										
    
											Condition(s)/Problem(s)
											
												
												* (N00-N99)Diseases of the genitourinary system 
    
												
												
												   (N94.6)Dysmenorrhoea, unspecified 
												
												
											    		
										
    
										
    
											Rare Disease
											
												
													
													No
												
											
										
    
										
    
											
												Inclusion Criteria
											
											
												
    Gender
    
												Female
											    		
										
    
										
    
											
												
    Age
    
												18Year~No Limit
											    		
										
    
										
    
											
												
    Description
    
												
    ○Experimental group
  • Females aged 18 or above
  • Menstrual cycle length of 21–39 days
  • Discomfort in daily life or interpersonal activities from menstrual pain
  • Score of 4 or above on MMP (Measure of Menstrual Pain)19
○ Control group
  • Female aged 18 or above 
  • Menstrual cycle length of 21–39 days
  • Little or no discomfort in daily life or interpersonal activities from menstrual pain
  • Score of 3 or below on MMP (Measure of Menstrual Pain)19
    
											    		
										
    
										
    
											
												Exclusion Criteria
											
											
												
      • Menstrual cycle length of less than 20 days or more than 40 days
  • Premenopausal symptoms (irregular menstruation, rosacea)
  • Polycystic Ovarian Syndrome
  • Sterility
  • Cancer history within the previous 5 years
  • Severe diseases with the potential to affect signs and symptoms
   - Cardiovascular disease, renal disease, diabetes, anemia 
   - Hypertensive patients unable to adjust blood pressure
   - Active liver disease or gallbladder disease
   - Hyper- or hypothyroidism
   - Psychiatric disorders or on antidepressants
   - Sanhupung (postpartum syndrome) or musculoskeletal diseases above moderate level
  • Otherwise assessed by the investigators to be either mentally or physically unsuitable to participate in the study
    
											    		
										
    
										
    
											
												Healthy Volunteers
											
											
												
													Yes
													
												
											
										
    
									    
								
    
							
    
						
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									10. Outcome Measure(s)
								
    
								
							
    
							
    
								
    
									Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
									
										
    
											
												
												Type of Primary Outcome
											
											 Not applicable
										
    
										
											
    
												
													Primary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    Menstrual Cycle Questionnaire
    		
											
    
											
    
												Timepoint
												
    visit 1 (the non-menstrual period was considered to be 7–10 days after the last day of menstruation)
    		
											
    
										
										
											
    
												
													Secondary Outcome(s) 1
												
											
    
											
    
												Outcome
												
    Hyungsang diagnosis by the 3-Dimensional Facial Shape Diagnostic System
    		
											
    
											
    
												Timepoint
												
    visit 1 (the non-menstrual period was considered to be 7–10 days after the last day of menstruation), visit 2(the menstrual period measurements were taken within 2–3 days following the first day of menstruation
    		
											
    
										
											
    
												
													Secondary Outcome(s) 2
												
											
    
											
    
												Outcome
												
    Pulse wave measurement using a blood pressure pulse analyzer (3D MAC: Daeyomedi, Korea)
    		
											
    
											
    
												Timepoint
												
    visit 1 (the non-menstrual period was considered to be 7–10 days after the last day of menstruation), visit 2(the menstrual period measurements were taken within 2–3 days following the first day of menstruation
    		
											
    
										
											
    
												
													Secondary Outcome(s) 3
												
											
    
											
    
												Outcome
												
    Diagnosis System of Oriental Medicine
    		
											
    
											
    
												Timepoint
												
    visit 1 (the non-menstrual period was considered to be 7–10 days after the last day of menstruation), visit 2(the menstrual period measurements were taken within 2–3 days following the first day of menstruation
    		
											
    
										
									    
								
    
							
    
						
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									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
											
												
													Yes
													
												
												
												
											
										
    
										
											
    
												Final Enrollment Number
												 
											
    
											
    
												Number of Publication
												1
											
    
											
												
    
													Publications 1
													
														
    Soo Hyung Jeon, Kyu Kon Kim, In Seon Lee, Yong Tae Lee, Gyeong Cheol Kim,Gyoo Yong Chi, Hye Sook Cho, Hee Jung Kang and JongWon Kim. Pulse Wave Variation during the Menstrual Cycle in Women with Menstrual Pain. BioMed Research International. SCI. 2016- ,
														 VOL :  page :  ~ 
														
														
    
													    		
												
    
											
											
    
												Results Upload
												
													
												
											
    
											
    
												Date of Posting Results
												2016/05/24
											
    
											
    
												Protocol URL or File Upload
												
													
													
													
												
											
    
											
    
												Brief Summary
												
    		
											
    
										
									    
								
    
							
    
						
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									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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