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A Clinical Trial to Analyze the effect of oral intake of Phellinus linteus(sanghuang) Extract on immune function: Randomized, Double-blind Controlled Trial

Status Approved

  • First Submitted Date

    2020/09/25

  • Registered Date

    2020/10/12

  • Last Updated Date

    2020/09/25

  • 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
    KCT0005460
    Unique Protocol ID DJUMC-2020-BM-07
    Public/Brief Title A Clinical Trial to Analyze the effect of oral intake of Phellinus linteus(sanghuang) Extract on immune function: Randomized, Double-blind Controlled Trial
    Scientific Title A Clinical Trial to Analyze the effect of oral intake of Phellinus linteus(sanghuang) Extract on immune function: Randomized, Double-blind Controlled Trial
    Acronym A Clinical Trial to Analyze the effect of oral intake of Phellinus linteus(sanghuang) Extract on immune function: Randomized, Double-blind Controlled Trial
    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 DJUMC-2020-BM-07
    Approval Date 2020-08-12
    Institutional Review Board Name Cheonan Korean Medicine Hospital of Daejeon university IRB
    Institutional Review Board Address 4, Notaesan-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do
    Institutional Review Board Telephone 041-521-7013
    Data Monitoring Committee
  • 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 Jae Hui Kang
    Title Associate Professor
    Telephone +82-41-521-7579
    Affiliation Daejeon University
    Address 62 Daehak-ro, Dong-gu, Daejeon
    Contact Person for Public Queries
    Name Yong Ho Ku
    Title Resident
    Telephone +82-41-521-7579
    Affiliation Cheonan Korean Medicine Hospital of Daejeon University
    Address 4, Notaesan-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-do
    Contact Person for Updating Information
    Name Yong Ho Ku
    Title Resident
    Telephone +82-41-521-7579
    Affiliation Cheonan Korean Medicine Hospital of Daejeon University
    Address 4, Notaesan-ro, Seobuk-gu, Cheonan-si, Chungcheongnam-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 Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-09-25 Anticipated
    Target Number of Participant 98
    Primary Completion Date 2021-03-31 , Anticipated
    Study Completion Date 2021-03-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Cheonan Korean Medicine Hospital of Daejeon University
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2020-09-25 ,
  • 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 Trade, Industry & Energy
    Organization Type Government
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Cheonan Korean Medicine Hospital of Daejeon University
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    This clinical trial was designed to evaluate the efficacy and safety of enhancing immune function compared to a control food (Placebo) when ingesting Phellinus linteus(sanghuang) extract in adults with reduced immune function. Human subjects will voluntarily sign the agreement for human application tests, determine whether they meet the selection criteria/exclusion criteria through visit evaluation, and then enter one of the test group and the control group according to the order in which appropriate human subjects are registered. Randomly assigned. Assigned subjects consume food for human application test (test food or control food) twice/day for 8 weeks. The purpose of this human application test is to prove that the test group (Psidium mushroom mycelium extract) is superior to the control group (Placebo) in increasing NK cell activity after 8 weeks of administration.
  • 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
    Others
    (It was planned to evaluate the efficacy and safety of enhancing immune function compared to the control food (Placebo) when ingesting Phellinus linteus(sanghuang) extract)
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Double
    Blinded Subject Subject, Investigator
    Allocation RCT
    Intervention Type Dietary Supplement  
    Intervention Description
    Test food: Phellinus linteus(sanghuang) extract (1,000 mg/day)
    Control food: placebo (dextrin 1,000 mg/day)
    Take orally for 8 weeks, twice a day, 1 capsule at a time.
    Number of Arms 2
    Arm 1

    Arm Label

    Experimental group

    Target Number of Participant

    49

    Arm Type

    Experimental

    Arm Description

    Phellinus linteus(sanghuang) extract 1,000mg/day twice a day, once a capsule taken orally for 8 weeks
    Arm 2

    Arm Label

    Control group

    Target Number of Participant

    49

    Arm Type

    Placebo comparator

    Arm Description

    Take the placebo formulation orally twice a day, one capsule at a time for 8 weeks
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (D50-D89)Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism 
       (D84.9)Immunodeficiency, unspecified 

    Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~65Year

    Description

    1. Men and women aged 20 to 65 years old
    2. Peripheral blood WBC of 3×1000/μl or more and less than 10×1000/μl
    3. Those who have had upper respiratory tract infections or cold symptoms, a typical disease that can cause upper respiratory tract infections, more than two times within one year before the start of the test
    4. A person who has agreed to participate in this test and signed a written consent form by the subject (or legal representative) voluntarily
    Exclusion Criteria
    1. Those who are currently being treated for clinically significant acute or chronic cardio-cerebrovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal disease, psychotic, infectious and hematologic/neoplastic diseases, etc. You can participate in the research at the discretion of the research director considering the status of
    2. Those with uncontrolled hypertension (160/100mmHg or more, measured after 10 minutes of rest for the subject)
    3. Patients with uncontrolled diabetes (fasting glucose 126mg/dL or higher, or starting a new drug due to diabetes within 3 months)
    4. Those whose AST(GOT) or ALT(GPT) blood level is 3 times or more than the normal upper limit of the relevant organ7,8,9
    5. Creatinine blood levels exceeding 2.4mg/dL for men and 1.8mg/dL for women
    6. Those who have consumed or are ingesting health functional foods that may affect immunity within 2 weeks before screening
    7. Those who complain of severe gastrointestinal symptoms such as heartburn and indigestion
    8. Pregnant, lactating or planning to become pregnant during the study period
    9. Those who are sensitive or allergic to test food related foods
    10. Those who plan to participate in other studies during this study
    11. Those who received other study drugs within 4 weeks of starting this study
    12. Those who the researcher deems unsuitable for this study
    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
    NK cell activity
    Timepoint
    0 weeks (before intake), 8 weeks
    Secondary Outcome(s) 1
    Outcome
    WBC
    Timepoint
    0 weeks (before intake), 8 weeks
    Secondary Outcome(s) 2
    Outcome
    IFN-γ
    Timepoint
    0 weeks (before intake), 8 weeks
    Secondary Outcome(s) 3
    Outcome
    IL-1β, IL-2, IL-6, IL-12
    Timepoint
    0 weeks (before intake), 8 weeks
    Secondary Outcome(s) 4
    Outcome
    IgG1, IgG2, IgM
    Timepoint
    0 weeks (before intake), 8 weeks
    Secondary Outcome(s) 5
    Outcome
    TNF-α
    Timepoint
    0 weeks (before intake), 8 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 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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