<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02244372</url>
  </required_header>
  <id_info>
    <org_study_id>CHE-PI-CM</org_study_id>
    <nct_id>NCT02244372</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity</brief_title>
  <official_title>A 8-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Cordyceps Sinensis Mycelium Culture Extract(Paecilomyces Hepiali, CBG-CS-2) on Promotion of Immunity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chonbuk National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chonbuk National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators performed randomized, double-blind, placebo-controlled human trial to&#xD;
      evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces&#xD;
      hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity&#xD;
      parameters , including Cytotoxicity, Cytokine (IL-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP,&#xD;
      antibody titer, and upper respiratory tract infection(URI)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in Cytotoxicity</measure>
    <time_frame>4, 8 weeks</time_frame>
    <description>Cytotoxicity was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week). cytotoxicity was measured by NK cell activity.&#xD;
Cytotoxicity (%) = (experimental release - spontaneous release) / (maximum release - spontaneous release) x 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α)</measure>
    <time_frame>4, 8 weeks</time_frame>
    <description>Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α) was measured in study visit 1(0 week), visit 2(4 week), and visit 3(8 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in hs-CRP</measure>
    <time_frame>4, 8 weeks</time_frame>
    <description>hs-CRP was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Immunity</condition>
  <arm_group>
    <arm_group_label>Cordyceps sinensis mycelium culture extract 0.76 g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cordyceps sinensis mycelium culture extract 0.76 g</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cordyceps sinensis mycelium culture extract 1.15 g</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cordyceps sinensis mycelium culture extract 1.15 g</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cordyceps sinensis mycelium culture extract 0.76 g</intervention_name>
    <arm_group_label>Cordyceps sinensis mycelium culture extract 0.76 g</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Cordyceps sinensis mycelium culture extract 1.15 g</intervention_name>
    <arm_group_label>Cordyceps sinensis mycelium culture extract 1.15 g</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females 20-80 years old&#xD;
&#xD;
          -  Who had suffered more than twice Upper respiratory infection* disorder or common cold&#xD;
             causing URI&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  WBC concentration below 3000 ㎕&#xD;
&#xD;
          -  Subjects vaccinated against influenza within the last 6 months prior to the study&#xD;
&#xD;
          -  Subjects with Upper respiratory infection at screening visit&#xD;
&#xD;
          -  Subjects with BMI &lt; 18.5 kg/m2 at screening visit&#xD;
&#xD;
          -  Allergic or hypersensitive to any of the ingredients in the test products&#xD;
&#xD;
          -  Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic,&#xD;
             renal failure, and diabetes&#xD;
&#xD;
          -  History of reaction to any of the test products or of gastrointestinal diseases such&#xD;
             as Crohn's disease or gastrointestinal surgery&#xD;
&#xD;
          -  History of alcohol or substance abuse&#xD;
&#xD;
          -  Participation in any other clinical trials within past 2 months&#xD;
&#xD;
          -  Laboratory test, medical or psychological conditions deemed by the investigators to&#xD;
             interfere with successful participation in the study&#xD;
&#xD;
          -  Pregnant or lactating women etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinical Trial Center for Functional Foods; Chonbuk National University Hospital</name>
      <address>
        <city>Jeonju</city>
        <state>Jeollabuk-do</state>
        <zip>560-822</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>August 21, 2019</last_update_submitted>
  <last_update_submitted_qc>August 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chonbuk National University Hospital</investigator_affiliation>
    <investigator_full_name>Soo-Wan Chae</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Trial Center for Functional Foods</investigator_title>
  </responsible_party>
  <keyword>Cordyceps sinensis mycelium culture extract(Paecilomyces hepiali, CBG-CS-2)</keyword>
  <keyword>immunity</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02244372
org study id: CHE-PI-CM
nct id: NCT02244372
lead sponsor: 
has dmc: Yes
The investigators performed randomized, double-blind, placebo-controlled human trial to
      evaluate the efficacy and safety of Cordyceps sinensis mycelium culture extract (Paecilomyces
      hepiali, CBG-CS-2) on promotion of immunity. The investigators measured promotion of immunity
      parameters , including Cytotoxicity, Cytokine (IL-4, IL-6, IL-12, IFN-γ, TNF-α), hs-CRP,
      antibody titer, and upper respiratory tract infection(URI)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes in Cytotoxicity
time frame: 4, 8 weeks
description: Cytotoxicity was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week). cytotoxicity was measured by NK cell activity.
Cytotoxicity (%) = (experimental release - spontaneous release) / (maximum release - spontaneous release) x 100
measure: Changes in Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α)
time frame: 4, 8 weeks
description: Cytokine(IL-4, IL-6, IL-12, IFN-γ, TNF-α) was measured in study visit 1(0 week), visit 2(4 week), and visit 3(8 week).
measure: Changes in hs-CRP
time frame: 4, 8 weeks
description: hs-CRP was measured in study visit 1(0 week), visit 2(4 week) and visit 3(8 week).
arm group label: Cordyceps sinensis mycelium culture extract 0.76 g
arm group type: Experimental
description: Cordyceps sinensis mycelium culture extract 0.76 g
arm group label: Cordyceps sinensis mycelium culture extract 1.15 g
arm group type: Experimental
description: Cordyceps sinensis mycelium culture extract 1.15 g
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Dietary Supplement
intervention name: Cordyceps sinensis mycelium culture extract 0.76 g
arm group label: Cordyceps sinensis mycelium culture extract 0.76 g
intervention type: Dietary Supplement
intervention name: Cordyceps sinensis mycelium culture extract 1.15 g
arm group label: Cordyceps sinensis mycelium culture extract 1.15 g
intervention type: Dietary Supplement
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Soo-Wan Chae
investigator title: Principal Investigator, Clinical Trial Center for Functional Foods