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A multi-center, randomized, double-blind, and controlled a clinical study for improvement of bone health via the analysis of effect of ferment oyster extract

Status Approved

  • First Submitted Date

    2021/01/08

  • Registered Date

    2021/03/26

  • Last Updated Date

    2021/03/23

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
    KCT0006032
    Unique Protocol ID 2020008
    Public/Brief Title A multi-center, randomized, double-blind, and controlled a clinical study for improvement of bone health via the analysis of effect of ferment oyster extract.
    Scientific Title A multi-center, randomized, double-blind, and controlled a clinical study for improvement of bone health via the analysis of effect of ferment oyster extract
    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 2020008
    Approval Date 2020-03-10
    Institutional Review Board Name Pusan National University Korean Medicine Hospital Institutional Review Board
    Institutional Review Board Address 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do
    Institutional Review Board Telephone 055-360-5902
    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 IN HEO
    Title Professor
    Telephone +82-55-360-5966
    Affiliation Pusan National University Korean Medicine Hospital
    Address 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do
    Contact Person for Public Queries
    Name Hyun Tae Kim
    Title KMD
    Telephone +82-55-360-5966
    Affiliation Pusan National University Korean Medicine Hospital
    Address 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do
    Contact Person for Updating Information
    Name Hyun Tae Kim
    Title KMD
    Telephone +82-55-360-5966
    Affiliation Pusan National University Korean Medicine Hospital
    Address 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do
  • 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 Not yet recruiting
    Date of First Enrollment 2021-04-05 Anticipated
    Target Number of Participant 120
    Primary Completion Date 2021-12-31 , Anticipated
    Study Completion Date 2021-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Pusan National University Korean Medicine Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-04-05 ,
    Recruitment Status by Participating Study Site 2
    Name of Study Dong-A University Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2021-04-05 ,
  • 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 MARINE BIOPROCESS
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Pusan National University Korean Medicine Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This study investigated whether fermented oyster extract as a functional raw material for health functional food is safe and clinically and scientifically analyzed and evaluated whether there is an effect on health. The human application test was designed as a multi-center, double-blind, randomized, and control food comparison test.
     If the subject voluntarily agrees in writing to participate in the clinical trial, the subject's suitability is evaluated after performing the necessary examinations and tests in accordance with the human application trial plan, and the test according to a pre-generated random assignment only to those who meet the selection/exclusion criteria. Randomized 1:1 as a group control.
     Research subjects randomly assigned are given trial food and dosing diary, etc.
    Take it once daily according to the prescribed method. On days 0, 56, 112, and 168, the efficacy and safety endpoints are measured and tested, and the results are analyzed.
  • 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 Others (Fermented Oyster Extract)
    Intervention Description
    Fermented oyster extract, 1,400mg/day, once a day, once a day 350mg 4 capsules,
    Take it with water after dinner
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental group

    Target Number of Participant

    80

    Arm Type

    Experimental

    Arm Description

    Fermented oyster extract, 1,400mg/day, once a day, once a day 350mg 4 capsules,
    Take it with water after dinner for 168 days (24 weeks)
    Arm 2

    Arm Label

    Placebo comparator

    Target Number of Participant

    80

    Arm Type

    Placebo comparator

    Arm Description

    Dextrin, 1,400mg/day, once a day, once a day 350mg 4 capsules,
    Take it with water after dinner for 168 days (24 weeks)
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (M00-M99)Diseases of the musculoskeletal system and connective tissue 
       (M81.09)Postmenopausal osteoporosis, site unspecified 

    1) Women over the age of 45 2) The next confirmed menopause ① Those who have passed more than 1 year after the last menstruation as of the screening date ② Natural amenorrhea or screening for 6 months based on the biochemical criteria for menopause (FSH> 40 IU) Received bilateral oophorectomy ≥ 6 weeks prior to visit.
    Rare Disease No
    Inclusion Criteria

    Gender

    Female

    Age

    45Year~No Limit

    Description

    1) Women over the age of 45
    2) The next confirmed menopause
    ① Those who have passed more than 1 year after the last menstruation as of the screening date
    ② Natural amenorrhea or screening for 6 months based on the biochemical criteria for menopause (FSH> 40 IU)
    Received bilateral oophorectomy ≥ 6 weeks prior to visit.
    Exclusion Criteria
    1) Those who received treatment such as Hormone replacement therapy, calcitonin, bisphosphonate within 6 months before screening test
    
    2) Those who have been taking beta-adrenergic receptor inhibitors within 2 months prior to screening test
    
     3) People with diabetes/hyperlipidemia that cannot be controlled within 2 months before screening test or People who take soy-containing health functional food
    
    4) Within 2 months before the screening test, People who took herbal medicines (Ogapi, Hogol, Gokgisaeng, Sangsaeng) which can affect bone metabolism, treatments such as steroids (Dynol tablet, Edgol tablet, Won Alpha Tablet, Premina Tablet, Posteage, Preda Tablet). Those who have consumed healthy foods (soy isoflavone, black yeast culture powder, milk protein extract) which can affect bone metabolism, 
    
    5) People with liver disease or AST or ALT greater than twice the upper limit of normal
    
    6) Patients with uncontrolled high blood pressure or heart disease such as angina pectoris-myocardial infarction
    
    7) Patients with uncontrolled hyperthyroidism or hypothyroidism
    
    8) Those who have taken other clinical trial drugs within 1 month
    
    9) Those suffering from diseases affecting bone metabolism (cirrhosis/chronic renal failure/drug treatment Necessary anemia)
    
    10) Patients with medically inappropriate administration of test food
    
    11) Alcohol abuser
    
    12) People with osteoporosis-related or other concomitant diseases that may affect the drug safety evaluation
    
    13) Those who are being treated for psychiatric diseases
    
    14) Others, those who are judged to be inappropriate by the judgment of the responsible researcher and the person in charge of testing
    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 /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    osteocalcin
    Timepoint
    0, 168th day
    Secondary Outcome(s) 1
    Outcome
    Deoxypyridinoline
    Timepoint
    0, 168th day
    Secondary Outcome(s) 2
    Outcome
    DPD/OSC ratio
    Timepoint
    0, 168th day
    Secondary Outcome(s) 3
    Outcome
    Bone Alkaline Phosphate
    Timepoint
    0, 168th day
    Secondary Outcome(s) 4
    Outcome
    Ca
    Timepoint
    0, 168th day
    Secondary Outcome(s) 5
    Outcome
    WOMAC
    Timepoint
    0, 168th day
    Secondary Outcome(s) 6
    Outcome
    C-telopeptide of type-I collagen
    Timepoint
    0, 168th day
    Secondary Outcome(s) 7
    Outcome
    N-telopeptide of type-I collagen
    Timepoint
    0, 168th day
    Secondary Outcome(s) 8
    Outcome
    BMD
    Timepoint
    0, 168th day
    Secondary Outcome(s) 9
    Outcome
    Estrogen
    Timepoint
    0, 168th day
    Secondary Outcome(s) 10
    Outcome
    Growth Hormone
    Timepoint
    0, 168th day
  • 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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