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Protective effects of Korean Red Ginseng on Endocrine Disrupting Bisphenol A in Humans

Status Approved

  • First Submitted Date

    2013/11/11

  • Registered Date

    2013/11/12

  • Last Updated Date

    2013/11/14

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
    KCT0000920
    Unique Protocol ID SM-IRB-10-0720-004
    Public/Brief Title Effects of Korean Red Ginseng for detoxification of bisphenol A, an endocrine disrupting chemical
    Scientific Title Protective effects of Korean Red Ginseng on Endocrine Disrupting Bisphenol A in Humans
    Acronym krg
    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 SM-IRB-10-0720-004
    Approval Date 2010-08-03
    Institutional Review Board Name Instritute Review Board of Sookmyung Women's University
    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 Mihi Yang
    Title Ph. D.
    Telephone +82-2-2077-7179
    Affiliation Sookmyung Women's Hospital
    Address
    Contact Person for Public Queries
    Name Mihi Yang
    Title Ph. D.
    Telephone +82-2-2077-7179
    Affiliation Sookmyung Women's Hospital
    Address
    Contact Person for Updating Information
    Name Mihi Yang
    Title Ph. D.
    Telephone +82-2-2077-7179
    Affiliation Sookmyung Women's Hospital
    Address
  • 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 2010-09-01 Actual
    Target Number of Participant 22
    Primary Completion Date 2010-12-31 , Actual
    Study Completion Date 2011-03-10
    Recruitment Status by Participating Study Site 1
    Name of Study Sookmyung Women's Hospital
    Recruitment Status Completed
    Date of First Enrollment 2010-09-01 ,
  • 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 Korean Society of Ginseng
    Organization Type Research Institute
    Project ID 18
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Sookmyung Women's Hospital
    Organization Type University
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Ethnopharmacological relevance: Korean red ginseng is a processed ginseng to enhance safety, preservation and efficacy. We studied safety and efficacy of KRG, focusing on female quality of life (QOL) and exposure to bisphenol A (BPA), an endocrine disrupting chemical, and investigated individual variations in susceptibility to KRG with the Sasang Typology, the personalized medicine used for hundred years in Korea.
    Materials and Methods: We performed a single-blind randomized clinical trial. Study subjects were young women (N=22), consumed 2.7 g of KRG or placebo powder/day for 2 weeks and answered questionnaires including gynecologic complaints at the 4 time spots during the trial. We diagnosed the Sasang Typology with the questionnaire for the Sasang constitution Classification II (QSCCⅡ) and analyzed urinary total BPA and malondialdehyde (MDA), an oxidative stress biomarker.
    Results: The KRG consumption decreased urinary BPA  and MDA levels (ps<0.05) and alleviated ‘menstrual irregularity’, ‘menstrual pain’, and ‘constipation’ (ps<0.05). Soeumin (Lesser Yin person) showed KRG-related alleviation in insomnia, flushing, perspiration and appetite, rather than other Sasang types. During the KRG-intervention, no one experienced side effects of raw ginseng.
    
  • 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 Phase1
    Intervention Model Parallel  
    Blinding/Masking Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    take 9 capsules of placebo or KRG (2.7 g of KRG powder)/day after meals for 2 weeks
    Number of Arms 2
    Arm 1

    Arm Label

    placebo

    Target Number of Participant

    11

    Arm Type

    Placebo comparator

    Arm Description

    take 9 capsules of placebo (238.13 mg of corn starch, 10 mg of powder flavor of KRG and 1.88 mg of coloring matters/capsule)/day after meals for 2 weeks
    Arm 2

    Arm Label

    KRG group

    Target Number of Participant

    11

    Arm Type

    Experimental

    Arm Description

    take 9 capsules of placebo or KRG (2.7 g of KRG powder)/day after meals for 2 weeks
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (N00-N99)Diseases of the genitourinary system 
       (N94.6)Dysmenorrhoea, unspecified 
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    20Year~25Year

    Description

    Volunteers, who experienced menstrual pain or irregularity were recruited , were on 7-11 days after the last menstruation and without bleeding. 
    Exclusion Criteria
    people who had any medicine for diseases
    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 Efficacy
    Primary Outcome(s) 1
    Outcome
    questionnaires containing items of quality of life (QOL) including the 17 complaints
    Timepoint
    before the trial and after the next menstruation
    Secondary Outcome(s) 1
    Outcome
    urinary bisphenol a and maldondialdehyde
    Timepoint
    day 0, 4, 8 and 14 days during the trial (4 spots)
  • 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
    Mihi Yang, Min-Woo Hwang, Mirim Jin. Effects of Korean Red Ginseng (Panax Ginseng Meyer)
    on Bisphenol A Exposure and Gynecologic Complaints 
    . BMC Complementary and Alternative Medicine. SCI. - ,
    														 VOL :  page :  ~ 
    														
    														
    Results Upload
    Date of Posting Results 2013/11/12
    Protocol URL or File Upload
    Brief Summary
  • 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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