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A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Soybean extract complex on menopausal symptoms.

Status Approved

  • First Submitted Date

    2021/03/15

  • Registered Date

    2021/03/24

  • Last Updated Date

    2021/03/15

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
    KCT0006019
    Unique Protocol ID 4-2014-0399
    Public/Brief Title Clinical trial for the evaluation of the efficacy and safety of isoflavone on menopausal symptoms.
    Scientific Title A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of Soybean extract complex on menopausal symptoms.
    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 4-2014-0399
    Approval Date 2014-07-09
    Institutional Review Board Name Yonsei University Health System, Severance Hospital, Institutional Review Board
    Institutional Review Board Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
    Institutional Review Board Telephone 02-2228-0500
    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 Seok Kyo Seo
    Title professor
    Telephone +82-2-2228-2236
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
    Contact Person for Public Queries
    Name Hye In Kim
    Title fellow
    Telephone +82-2-2228-2236
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of Korea
    Contact Person for Updating Information
    Name Seok Kyo Seo
    Title professor
    Telephone +82-2-2228-2236
    Affiliation Yonsei University Health System, Severance Hospital
    Address 50-1, Yonsei-ro, Seodaemun-gu, Seoul, Republic of 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 Multi-center Number of center : 2
    Overall Recruitment Status Completed
    Date of First Enrollment 2014-07-16 Actual
    Target Number of Participant 80
    Primary Completion Date 2015-10-05 , Actual
    Study Completion Date 2016-03-25 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Yonsei University Health System, Severance Hospital
    Recruitment Status Completed
    Date of First Enrollment 2014-07-22 ,
    Recruitment Status by Participating Study Site 2
    Name of Study National Health Insurance Service Ilsan Hospital
    Recruitment Status Completed
    Date of First Enrollment 2014-07-16 ,
  • 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 Pulmuone
    Organization Type Others
    Project ID PMO_CPX
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Pulmuone
    Organization Type Others
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study was conducted as a double-blind, randomized, placebo-controlled clinical trial. The aim of this study was to evaluate the efficacy and safety of Soybean extract complex on menopausal symptoms in postmenopausal women. Forty participants were randomly assigned to the placebo group, and another 40 were placed in the Soybean extract complex group.
  • 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
     Supportive Care
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    The soybean extract complex group took one tablet two times a day (Soybean extract complex 190mg/day) for 12 weeks.
    The placebo group was provided with identically shaped tablet. The placebo was also taken two times a day for 12 weeks.
    Number of Arms 2
    Arm 1

    Arm Label

    The soybean extract complex group

    Target Number of Participant

    40

    Arm Type

    Active comparator

    Arm Description

    The soybean extract complex group took one tablet two times a day (Soybean extract complex 190mg/day) for 12 weeks.
    Arm 2

    Arm Label

    The placebo group

    Target Number of Participant

    40

    Arm Type

    Placebo comparator

    Arm Description

    The placebo group took one identically shaped placebo tablet two times a day for 12 weeks.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (N00-N99)Diseases of the genitourinary system 
       (N95.1)Menopausal and female climacteric states 

    postmenopause
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    40Year~60Year

    Description

    1) Postmenopausal women aged between 40 and 60 years.
    2) Modified kupperman index > 20
    Exclusion Criteria
    1) BMI (Body Mass Index)> 30 Kg/m2
    2) Women used hormone therapy for the past 3 months
    3) Women with endometrial hyperplasia, cevical cencer, endometrial cacer, breast cancer, or estrogen dependent tumor
    4) Women with severe migrane, thromboembolism, cerebrovascular disease, or cardiovascular disease for the past one year
    5) Women with psychical disorder
    6) Women with undiagnosed vaginal bleeding
    7) Women with uncontrolled hypertension(> 160/100mmHg)
    8) Women with uncontrolled DM (fasting glucose > 180mg/dL or started new DM drug within 3 months)
    9) Women with uncontrolled thyroid disease
    10) Women with drug or alcohol abuse
    11) More than three times over the normal limit of ALT or AST
    12) More than two times over the normal limit of creatinine
    13) Women with abnormal mammography/PAP smear (BI-RADS Category > 3, PAP smear > ASCUS)
    14) Women with partitipating other clinical trial
    15) if reserchers are deemed inappropriate in this clinical trial
    16) Women used thyroid hormone, Clonidine, anticoagulant agent(Warfarin, Aspirin, Clipidogrel)within 3 months
    17) Women used complementary and alternative medicine for the past 1 months
    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
    Changes of Modified KMI scores
    Timepoint
    After 6 weeks and 12 weeks
    Secondary Outcome(s) 1
    Outcome
    Changes of Modified KMI subcategories score, ALP, OC, and urine-NTx
    Timepoint
    After 6 weeks and 12 weeks
  • 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
    Results Upload
    Final Enrollment Number 80
    Number of Publication 0
    Results Upload 결과보고서요약.pdf
    Date of Posting Results 2021/03/24
    Protocol URL or File Upload 프로토콜.pdf
    Brief Summary
    In this study, through the Modified KMI questionnaire, it was confirmed that very significant menopausal symptoms and even some vasomotor symptoms were improved. In particular, in this study, there were significant differences between groups ingested at 12 weeks in the symptoms of numbness, fatigue symptoms, muscle joint pain, chest palpitations, vaginal dryness and decreased secretion. However, it had no effect on emotions, sleep, pain, and cognitive impairment. In other studies, both soybean and hop extracts were reported to be very effective in relation to hot flushing. In this study, the test group showed a higher decrease, but there was no significant difference between the intake groups. This can be attributed to the fact that the characteristic imagination of the study, especially in a short period of time, is very sensitive to the placebo effect, which can have a great influence on the overall result, and that symptoms can naturally decrease with time. In the test group, the decrease in ALP, an indicator of bone loss, and Urine-NTX, a by-product produced during bone decomposition, could improve bone health as in previous studies, but there was no significant difference between the intake groups. This is thought to be helpful in evaluating more subjects and long-term intake.
  • 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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