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An observational study on diagnosis index of metabolic disease with blood-stasis

Status Approved

  • First Submitted Date

    2018/12/10

  • Registered Date

    2019/02/22

  • Last Updated Date

    2019/02/12

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    		 KCT0003548
    Unique Protocol ID DUIOH-2018-09-001-005
    Public/Brief Title Diagnosis index of metabolic disease with blood-stasis: an observational study
    Scientific Title An observational study on diagnosis index of metabolic disease with blood-stasis
    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 DUIOH-2018-09-001-005
    Approval Date 2018-11-07
    Institutional Review Board Name Dongguk University Ilsan Oriental Hospital Institutional Review Board
    Institutional Review Board Address 27, Dongguk-ro, Ilsandong-gu, Goyang-si, Gyeonggi-do
    Institutional Review Board Telephone 031-961-8405
    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 Soobin Jang
    Title Dr.
    Telephone +82-31-961-9111
    Affiliation Dongguk University
    Address 1672 Yuseongdae-ro, Yuseong-gu, Daejeon
    Contact Person for Public Queries
    Name Soobin Jang
    Title Dr.
    Telephone +82-42-868-9383
    Affiliation Dongguk University Ilsan Hospital
    Address 1672 Yuseongdae-ro, Yuseong-gu, Daejeon
    Contact Person for Updating Information
    Name Soobin Jang
    Title Dr.
    Telephone +82-42-868-9383
    Affiliation Korea Institute of Oriental Medicine
    Address 1672 Yuseongdae-ro, Yuseong-gu, Daejeon

  • 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 Recruiting
    Date of First Enrollment 2018-12-18 Actual
    Target Number of Participant 100
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Dongguk University Ilsan Oriental Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-12-18 ,

  • 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 K18192

  • 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 
    1. Objective
 • Verification of effectiveness of diagnosis for metabolic disease with blood-stasis

2. Background
 • Blood stasis cause increasing blood viscosity and decreasing blood flow velocity, therefore, blood stasis should be reinterpreted by scientifically identifying the concepts of blood and blood vessels
 • Necessity for developing monitoring system and treatment of Korean medicine

3. Plan 
 • This study is to recruit 100 adults without special restriction, and diagnostic index for blood-stasis and metabolic disease will be observed through measuring blood test, oximeter, ankle-brachial pressure index (ABI), body mass index (BMI), waist circumference, blood pressure, pulse rate, blood-stasis questionnaire.

  • 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 Cross-sectional  
    Target Number of Participant 100
    Cohort/Group Number 3
    Cohort/
    Group 1

    Cohort/Group Label

    Metebolic disease with Blood-stasis

    Cohort/Group Description

    Corresponds to one of the following (a) and (b), and satisfies (c) at the same time;
 (a)  Ankle-brachial pressure index (ABI) ≤0.9, 
 (b)  Both triglycerides (TG) ≥150 mg/dL & high density lipoprotein cholesterol (HDL-C) <40 mg/dL (men), 50 mg/dL (women),
 (c)  Blood-stasis syndrome questionnaire score ≥ 9
    Cohort/
    Group 2

    Cohort/Group Label

    Metebolic disease with non-Blood-stasis

    Cohort/Group Description

    Corresponds to one of the following (a) and (b), and satisfies (c) at the same time;
 (a)  Ankle-brachial pressure index (ABI) ≤0.9, 
 (b)  Both triglycerides (TG) ≥150 mg/dL & high density lipoprotein cholesterol (HDL-C) <40 mg/dL (men), 50 mg/dL (women), 
 (c)  Blood-stasis syndrome questionnaire score < 9
    Cohort/
    Group 3

    Cohort/Group Label

    Heathy control

    Cohort/Group Description

    Corresponds to both (a) and (b);
 (a)  Ankle-brachial pressure index (ABI) >0.9, 
 (b)  Both triglycerides (TG) <150 mg/dL &  high density lipoprotein cholesterol (HDL-C) ≥40 mg/dL (men), 50 mg/dL (women)
    Biospecimen
    Collection & Archiving    		 
    : DNA Collect & Archive: Sample without DNA
    Biospecimen Description 
    whole blood

  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description 
    South Korean men and women aged over 20 and under 70
    Sampling Method 
    Non-probability sampling
    Condition(s)/Problem(s) * (E00-E90)Endocrine, nutritional and metabolic diseases 
       (E88.9)Metabolic disorder, unspecified 

    Metabolic diseases, Hyperlipidemias, Atherosclerosis
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~69Year

    Description

    1. Those who voluntarily agreed to paricipate this study
2. Those who willing to cooperate during the study period and who will comply with restricstions
3. Those who have agreed to blood collection
    Exclusion Criteria 
    1. People with mental illness who are difficult to communicate
2. Those who are ill-informed and have difficulty communicating
3. Women who are pregnant
4. Those who are taking Herbal medicine for treatment of blood-stasis
5. Any person deemed unsuitable for participating in the study of human derivatives by other researchers
    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 
    Blood-stasis score
    Timepoint 
    Visit 1
    Secondary Outcome(s) 1
    Outcome 
    Resistin
    Timepoint 
    Visit 1
    Secondary Outcome(s) 2
    Outcome 
    Serum amyloid P
    Timepoint 
    Visit 1
    Secondary Outcome(s) 3
    Outcome 
    C-reactive protein
    Timepoint 
    Visit 1
    Secondary Outcome(s) 4
    Outcome 
    D-dimer
    Timepoint 
    Visit 1
    Secondary Outcome(s) 5
    Outcome 
    Triglycerides
    Timepoint 
    Visit 1
    Secondary Outcome(s) 6
    Outcome 
    High density lipoprotein cholesterol
    Timepoint 
    Visit 1
    Secondary Outcome(s) 7
    Outcome 
    Low density lipoprotein cholesterol
    Timepoint 
    Visit 1
    Secondary Outcome(s) 8
    Outcome 
    Ankle Brachial Pressure Index
    Timepoint 
    Visit 1
    Secondary Outcome(s) 9
    Outcome 
    Systolic blood pressure
    Timepoint 
    Visit 1
    Secondary Outcome(s) 10
    Outcome 
    Diastolic blood pressure
    Timepoint 
    Visit 1
    Secondary Outcome(s) 11
    Outcome 
    Body mass index
    Timepoint 
    Visit 1
    Secondary Outcome(s) 12
    Outcome 
    Waist circumference
    Timepoint 
    Visit 1
    Secondary Outcome(s) 13
    Outcome 
    Fasting blood sugar
    Timepoint 
    Visit 1

  • 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 No

  • 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 No
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