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Multi-center, randomized, wait-list controlled pilot study of GyeJibokryeong-hwan for shoulder discomfort relate to blood stasis

Status Approved

  • First Submitted Date

    2019/02/21

  • Registered Date

    2019/04/23

  • Last Updated Date

    2019/11/01

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    		 KCT0003837
    Unique Protocol ID SMCJH 1810-07
    Public/Brief Title Multi-center, randomized, wait-list controlled pilot study of GyeJibokryeong-hwan for shoulder discomfort relate to blood stasis
    Scientific Title Multi-center, randomized, wait-list controlled pilot study of GyeJibokryeong-hwan for shoulder discomfort relate to blood stasis
    Acronym
    MFDS Regulated Study Yes
    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 SMCJH 1810-07
    Approval Date 2018-11-16
    Institutional Review Board Name Semyung University Chungju Oriental Medicine Hospital
    Institutional Review Board Address 63, Sangbang 4-gil, Chungju-si, Chungcheongbuk-do
    Institutional Review Board Telephone 043-841-1738
    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 Ho-Yeon Go
    Title Professor
    Telephone +82-43-841-1731
    Affiliation Semyung University
    Address 63 Sangbang 4-gil, Chungju, Chungcheongbuk-do
    Contact Person for Public Queries
    Name Ho-Yeon Go
    Title Professor
    Telephone +82-43-841-1731
    Affiliation Semyung University
    Address 63 Sangbang 4-gil, Chungju, Chungcheongbuk-do
    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 Multi-center Number of center : 2
    Overall Recruitment Status Recruiting
    Date of First Enrollment 2019-06-03 Actual
    Target Number of Participant 40
    Primary Completion Date 2020-06-30 , Anticipated
    Study Completion Date 2020-09-30 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Chungju Oriental Hospital of Semyung University
    Recruitment Status Recruiting
    Date of First Enrollment 2019-09-06 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Semyung University Oriental Medicine Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2019-06-03 ,

  • 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 KSN1713041

  • 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 40 patients with sholder pain with blood-stasis and hyperlipidemia, and they will be assigned randomly to immediate treatment group or wait-list controlled group. Both groups will take GyeJibokryeong-hwan for 8 weeks and shoulder pain, blood-stasis score, blood test, oximeter, ankle-brachial pressure index (ABI), body mass index (BMI), waist circumference, and blood pressure will be measured.

  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose 
    Treatment
    Phase Phase4
    Intervention Model Cross-over  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug  
    Intervention Description 
    GyeJibokryeong-hwan (Hanpoong Pharm & Food Co., 3.0g, bid, oral administration for 8 weeks)
 - Arm 1 (Immediate treatment group) - taking Gyejibokryeong-hwan during 0-8 weeks after enrollment
 - Arm 2 (Wait-list treatment group) - taking Gyejibokryeong-hwan during 8-16 weeks after enrollment
    Number of Arms 2
    Arm 1

    Arm Label

    Wait-list treatment group

    Target Number of Participant

    20

    Arm Type

    Others

    Arm Description

    Taking Gyejibokryeong-hwan during 8-16 weeks after enrollment (Hanpoong Pharm & Food Co., 3.0g, bid, oral administration)
    Arm 2

    Arm Label

    Immediate treatment group

    Target Number of Participant

    20

    Arm Type

    Others

    Arm Description

    Taking Gyejibokryeong-hwan during 0-8 weeks after enrollment (Hanpoong Pharm & Food Co., 3.0g, bid, oral administration)

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M75.0)Adhesive capsulitis of shoulder 

    Shoulder pain
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~70Year

    Description

    1. Those who have shoulder pain with a Visual Analog Scale (VAS) score of 4 or more
2. Those who have blood-stasis score of 9 or more
3. triglycerides (TG) ≥150 mg/dL or total cholesterol (TC) ≥200 mg/dL
4. Those who voluntarily agreed to participate this study
5. Those who willing to cooperate during the study period and who will comply with restrictions
    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 paricipating in other clinical trial
5. Any person deemed unsuitable for participating in this study
    Healthy Volunteers No

  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome 
    Shoulder pain
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 1
    Outcome 
    Triglycerides 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 2
    Outcome 
    Total cholesterol
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 3
    Outcome 
    Ankle Brachial Pressure Index 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 4
    Outcome 
    Systolic blood pressure 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 5
    Outcome 
    Blood-stasis score
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 6
    Outcome 
    High density lipoprotein cholesterol 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 7
    Outcome 
    Low density lipoprotein cholesterol 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 8
    Outcome 
    Diastolic blood pressure 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 9
    Outcome 
    Waist circumference 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 10
    Outcome 
    Body mass index 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 11
    Outcome 
    Fasting blood sugar 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 12
    Outcome 
    Resistin 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 13
    Outcome 
    Serum amyloid P 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 14
    Outcome 
    C-reactive protein 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 15
    Outcome 
    D-dimer 
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 16
    Outcome 
    Oximeter
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 17
    Outcome 
    Adverse events
    Timepoint 
    4-week, 8-week, 16-week (Arm 1) / 12-week, 16-week (Arm 2)
    Secondary Outcome(s) 18
    Outcome 
    brachial-ankle pulse wave velocity (baPWV)
    Timepoint 
    0-day, 4-week, 8-week, 16-week (Arm 1) / 0-day, 8-week, 12-week, 16-week (Arm 2)

  • 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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