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Efficacy and Safety of GBE on andropause symptoms; A 8 weeks, Randomized, Double-blind, Placebo-Controlled Clinical Trial

Status Approved

  • First Submitted Date

    2020/09/10

  • Registered Date

    2020/10/12

  • Last Updated Date

    2020/09/10

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    		 KCT0005471
    Unique Protocol ID HB_GBE
    Public/Brief Title Efficacy and Safety of GBE on andropause symptoms; A 8 weeks, Randomized, Double-blind, Placebo-Controlled Clinical Trial
    Scientific Title Efficacy and Safety of GBE on andropause symptoms; A 8 weeks, Randomized, Double-blind, Placebo-Controlled Clinical Trial
    Acronym HB_GBE
    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 1971-001-378
    Approval Date 2019-10-16
    Institutional Review Board Name Chung-Ang University Hospital Institutional Review Board
    Institutional Review Board Address 102, Heukseok-ro, Dongjak-gu, Seoul
    Institutional Review Board Telephone 02-6299-2738
    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 Jinwook Kim
    Title Associate Professor
    Telephone +82-2-6299-1807
    Affiliation Chung-Ang Univerisity Hospital
    Address Chung-Ang Univerisity Hospital, 102 Heukseok-ro, Dongjak-gu, Seoul
    Contact Person for Public Queries
    Name Jinwook Kim
    Title Associate Professor
    Telephone +82-2-6299-1807
    Affiliation Chung-Ang Univerisity Hospital
    Address Chung-Ang Univerisity Hospital, 102 Heukseok-ro, Dongjak-gu, Seoul
    Contact Person for Updating Information
    Name Min-young Kim
    Title CRA
    Telephone +82-70-7730-4212
    Affiliation Neonutra
    Address 4F, 44 Daehak-ro, Jongno-gu, Seoul, 03122, 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 Single
    Overall Recruitment Status Active, not recruiting
    Date of First Enrollment 2020-02-17 Actual
    Target Number of Participant 100
    Primary Completion Date 2020-10-28 , Anticipated
    Study Completion Date 2020-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Chung-Ang Univerisity Hospital
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2020-02-17 ,

  • 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 Ministry of Agriculture, Food and Rural Affairs
    Organization Type Government
    Project ID

  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Holistic Bio
    Organization Type Others

  • 7. Study Summary

    Study Summary Information
    Lay Summary 
    This trial was planned to evaluate the efficacy and safety of menopausal men ingesting GBE on improvement of male menopausal symptoms compared to placebo.

  • 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 (health functional food)
    Intervention Description 
    Subjects are randomly assigned to either the test group or the control group according to the registered order. Subjects take investigational product or placebo for 8 weeks. 
Investigational product (GBE): once a day, 2 tablets orally intake (Ginseng Berry Extract 700mg/day) 
Placebo: consumed in the same way as the investigational product
    Number of Arms 2
    Arm 1

    Arm Label

    Ginseng Berry Extract

    Target Number of Participant

    50

    Arm Type

    Experimental

    Arm Description

    Two tablets are administered orally once a day for 8 weeks.
    Arm 2

    Arm Label

    Placebo comparator

    Target Number of Participant

    50

    Arm Type

    Placebo comparator

    Arm Description

    Two tablets are administered orally once a day for 8 weeks.

  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (N00-N99)Diseases of the genitourinary system 
       (N50.80)Male climacteric states 

    Andropause
    Rare Disease No
    Inclusion Criteria

    Gender

    Male

    Age

    40Year~No Limit

    Description

    1) Men over 40 years of age complaining of menopausal symptoms
2) Those who answered “yes” to Question 1 (“Is there a decrease in libido?”) or Question 7 (“Is there a decrease in erection?”) on the Male Menopausal Questionnaire (ADAM)
3) A person who consented to participate in this clinical trial and signed a Informed consent form before the trail began.
    Exclusion Criteria 
    1) Those who have used hormones such as male hormones or similar hormones (plant extracts, etc.) within 1 month of screening
2) Those who have used erectile dysfunction treatment (PDE5 inhibitor) within 1 month of screening
3) Those with a blood PSA (Prostate Specific Antigen) greater than 4 ng/mL
4) Those diagnosed with prostate cancer
5) Body Mass Index 40kg/m2 or more
6) Those who had a history of myocardial infarction, heart failure, cerebral infarction, cerebral hemorrhage, angina within 6 months of screening
7) Persons with severe mental illness such as depression, bipolar emotional disorder, schizophrenia, or currently taking psychotropic drugs such as antidepressants
8) Those with a history of endocrine diseases that may affect weight, such as hypothyroidism and Cushing's syndrome (those who are judged to be able to participate in this clinical trial by the Investigator can participate)
9) Uncontrolled hypertension persons (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measurement criteria after 10 minutes of stability in human subjects)
10) Those who have used insulin or hypoglycemic agents within 3 months of screening
11) Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the study institution 
12) Those whose Creatinine is more than twice the normal upper limit of the study institution 
13) Those who took appetite suppressants, appetite relievers, oral steroids, and thyroid hormones within 3 months of screening
14) Those with psychogenic menopausal disorder
15) Those with a history of alcoholism or substance abuse
16) Persons who are sensitive or allergic to investigational product for this clinical trial 
17) Those who participated in other clinical trials within 1 months of Visit 1 or plan to participate in other clinical trials after the start of this clinical trial. 
18) Those who have taken menopausal medicines or health functional foods within 1 month of screening
19) A person who determines that the Investigator is inappropriate for clinical trials
    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 
    change of ADAM(Androgen Deficiency in Aging Male)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 1
    Outcome 
    change of ADAM(Androgen Deficiency in Aging Male)'s Individual question
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 2
    Outcome 
    Total testosterone, Free testosterone
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 3
    Outcome 
    SHBG(Sex Hormone Binding Globulin), Albumin
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 4
    Outcome 
    Total Cholesterol, Triglyceride, HDL-Cholesterol, LDL-Cholesterol
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 5
    Outcome 
    total score of AMS(Aging Male’s symptom)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 6
    Outcome 
    total score of IPSS(International Prostate Symptom Score)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 7
    Outcome 
    total score and change of IIEF(International Index of Erectile Function)'s Individual question
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 8
    Outcome 
    LH(Luteinizing hormone)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 9
    Outcome 
    FSH(Follicle Stimulating Hormone)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 10
    Outcome 
    DHEA-S(Dehydroepiandrosterone Sulfate)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 11
    Outcome 
    IGF-1(Insulin-like growth factor-1)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 12
    Outcome 
    Estradiol
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 13
    Outcome 
    FBS(fasting blood sugar)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 14
    Outcome 
    Insulin
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 15
    Outcome 
    HOMA-IR(Homeostatic Model Assessment for Insulin Resistance)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 16
    Outcome 
    QUICKI(quantitative insulin sensitivity check index)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 17
    Outcome 
    HOMA-β(Homeostatic model assessment of β-cell function)
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 18
    Outcome 
    Blood pressure
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 19
    Outcome 
    waist circumference
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 20
    Outcome 
    hip circumference
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 21
    Outcome 
    weight
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 22
    Outcome 
    adverse event
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 23
    Outcome 
    Clinical pathology examination
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 24
    Outcome 
    pulse
    Timepoint 
    baseline, 8 week
    Secondary Outcome(s) 25
    Outcome 
    PSA(Prostate Specific Antigen)
    Timepoint 
    baseline, 8 week

  • 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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