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Exploratory observational study on the pulse waveform of dysmenorrhea patients and healthy subjects according to their menstrual period

Status Approved

  • First Submitted Date

    2015/07/31

  • Registered Date

    2015/08/27

  • Last Updated Date

    2017/02/03

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
    KCT0001604
    Unique Protocol ID PAS02-15D1-KH25
    Public/Brief Title Exploratory observational study on the pulse waveform of dysmenorrhea patients and healthy subjects according to their menstrual period
    Scientific Title Exploratory observational study on the pulse waveform of dysmenorrhea patients and healthy subjects according to their menstrual period
    Acronym
    MFDS Regulated Study Yes
    IND/IDE Protocol Yes
    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 KOMCIRB-150622-HR-021
    Approval Date 2015-06-30
    Institutional Review Board Name Kyung Hee University Korean Medicine 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 Youngbae Park
    Title Dr.
    Telephone +82-2-958-9242
    Affiliation Kyung Hee University
    Address College of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul, Korea
    Contact Person for Public Queries
    Name Hyunho Kim
    Title Dr.
    Telephone +82-2-958-9242
    Affiliation Kyung Hee University
    Address College of Oriental Medicine, Kyung Hee University, 1 Hoegi-dong, Dongdaemun-gu, Seoul, Korea
    Contact Person for Updating Information
    Name Jihye Kim
    Title Miss
    Telephone +82-42-868-9252
    Affiliation Korea Institute of Oriental Medicine
    Address Korea Institute of Oriental Medicine, 1672 Yuseongdae-ro, Yuseong-gu, Daejeon, 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
    Study Site Single
    Overall Recruitment Status Completed
    Date of First Enrollment 2015-08-10 Actual
    Target Number of Participant 48
    Primary Completion Date 2016-02-28 , Actual
    Study Completion Date 2016-02-28 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Kyung Hee University Oriental Medical Center
    Recruitment Status Completed
    Date of First Enrollment 2015-08-10 ,
  • 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 Korea Institute of Oriental Medicine
    Organization Type Research Institute
    Project ID K15023
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Korea Institute of Oriental Medicine
    Organization Type Research Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This is a protocol for an exploratory observational study that aims to assess the clinical efficacy of pulse tonometric device, and to determine whether the pulse tonometric device of diagnosis tools for primary dysmenorrhea can be used in clinic. This study will be conducted in a single center, case-controlled and exploratory observational study. A total of 48 participants will be enrolled in this study. The whole measurement process will be carried out in the Kyung Hee University Korean Medicine Hospital, Seoul, and Republic of Korea. Period of this study will be expected to be from June to November 2015. 
  • 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 48
    Cohort/Group Number 2
    Cohort/
    Group 1

    Cohort/Group Label

    Control (healthy subjects) group

    Cohort/Group Description

    Group 2 consisting of 24 females with few premenstrual symptoms and Visual Analogue Scale (VAS) score< 4 were taken as controls. Compare and analyze  pulse tonometric devices' parameters of dysmenorrhea patients group and control (healthy subjects) group.
    Cohort/
    Group 2

    Cohort/Group Label

    Dysmenorrhea patients group

    Cohort/Group Description

    Group 1 consisting of 24 females suffering from primary dysmenorrhea having Visual Analogue Scale (VAS) score ≥ 4. Compare and analyze pulse tonometric devices' parameters of dysmenorrhea patients group and control (healthy subjects) group.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    24 women who have menstrual pain (dysmenorrhea) and 24 women who haven't menstrual pain which are residing in Seoul, Korea.
    Sampling Method
    Non-probablity sampling
    Condition(s)/Problem(s) * (N00-N99)Diseases of the genitourinary system 
       (N94.4)Primary dysmenorrhoea 
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    20Year~30Year

    Description

    1) Female aged 20 to 30 years
    2) Women with a period cycle of 28 ± 3 days during last 3 months
    3) Women who have menstrual pain (dysmenorrhea) over 4 degrees by Visual Analogue Scale (VAS)
    4) Woman who can communicate with clinical study researcher and fill out a questionnaires
    5) Woman who have a voluntary agreement and participation in this clinical study
    6) Given written informed consent form.
    Exclusion Criteria
    1) Women with secondary dysmenorrhea caused by uterine myoma, endometriosis, ophorociptosis and infection of genitals confirmed by ultrasound exam
    2) Women who have medical operations and procedures
    3) who have major neuro-psychiatric disorder or have history of major neuro-psychiatric disorder, and women who are taking anti-depressant, anti-serotonin barbiturate, psychotropic drugs with 3 months
    4) Women who have major medical disease or have history of major medical disease (hypertension, diabetes, hyperlipidemia, gastritis, enteritis, gastro-esophageal reflux disease, Crohn’s disease etc.)
    5) Women who have an drastic diet within 1 week
    6) Women who are pregnant, as determined by a urine pregnancy test
    7) History of adverse reaction to pulse tonometric device
    8) Women who have congenital vascular anomaly and experience fracture of the wrist
    9) Received clinical study within one month prior to enrollment
    10) Any other condition likely in the judgment of the investigator that make the participants unable to complete, or is unsuitable for the study.
    Healthy Volunteers Yes
  • 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
    Pulse tonometric devices' parameter (pulse pressure index)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 1
    Outcome
    InBody 720s' parameters (intercellular water, extracellular water, protein, mineral, body fat mass, extracellular water/total body water ratio)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 2
    Outcome
    Total score of Measurement of Menstrual Pain (MMP)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 3
    Outcome
    Total score of Self-rating Anxiety Scale (SAS)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 4
    Outcome
    Toral score of Self-rating Depression Scale (SDS)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 5
    Outcome
    Total score of Cold and Heat Pattern Questionnaire (CHPQ)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 6
    Outcome
    Total score of Phlegm Pattern Questionnaire (PPQ)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 7
    Outcome
    Total score of Blood Stasis Pattern Questionnaire (BSPQ)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 8
    Outcome
    Total score of Food Accumulation Pattern Questionnaire (FAPQ)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 9
    Outcome
    Total score of Seven Emotions Pattern Questionnaire (SEPQ)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 10
    Outcome
    Total score of Fatigue Pattern Questionnaire (FPQ)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 11
    Outcome
    Pulse tonometric devices' parameter (pulse rate)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 12
    Outcome
    Pulse tonometric devices' parameters (pulse depth index)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 13
    Outcome
    Pulse tonometric devices' parameters (pulse volume index)
    Timepoint
    After completion of the clinical study
    Secondary Outcome(s) 14
    Outcome
    Tongue image
    Timepoint
    After completion of the clinical 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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