<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/NCT03028077</url>
  </required_header>
  <id_info>
    <org_study_id>CTCF2_2014_GN</org_study_id>
    <nct_id>NCT03028077</nct_id>
  </id_info>
  <brief_title>Effects of GS-3K8 and GINst15 on Acute Respiratory Illness</brief_title>
  <official_title>The Efficacy and Safety of GS-3K8 and GINst15 on Acute Respiratory Illness in Healthy Subjects</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>
      This study was conducted to investigate the effects of daily supplementation of GS-3K8 or&#xD;
      GINst15 on acute respiratory illness (ARI) in healthy subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Forty five&#xD;
      subjects were randomly divided into GS-3K8 (Ultrafiltered red ginseng extract) or GINst15&#xD;
      (Hydrolyzed ginseng extract) or placebo group. The primary clinical outcome measure was the&#xD;
      incidence of ARI. The secondary clinical outcome measure was the development and duration of&#xD;
      ARI symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Incidence rate of ARI (by questionnaire)</measure>
    <time_frame>18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)</time_frame>
    <description>Incidence of ARI were assessed before and after intervention and followed up for 6 weeks after termination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of ARI symptoms (by questionnaire)</measure>
    <time_frame>18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)</time_frame>
    <description>Development of ARI symptoms (score) were assessed before and after intervention and followed up for 6 weeks after termination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of ARI symptoms (by questionnaire)</measure>
    <time_frame>18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)</time_frame>
    <description>Duration of ARI symptoms were assessed before and after intervention</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Acute Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>GS-3K8</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GS-3K8 (6 cap/day, 500 mg/cap) for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GINst15</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GINst15 (6 cap/day, 500 mg/cap) for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>GS-3K8</intervention_name>
    <description>GS-3K8 (ultrafiltered red ginseng extract) 1 g/day</description>
    <arm_group_label>GS-3K8</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>GINst15</intervention_name>
    <description>GINst15 (hydrolyzed ginseng extract) 1 g/day</description>
    <arm_group_label>GINst15</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo 1 g/day</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 39-65 years with healthy adults&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects had been vaccinated against influenza in the previous 6 months&#xD;
&#xD;
          -  Subjects with symptoms of upper respiratory tract infection&#xD;
&#xD;
          -  Subjects with acute/chronic disease&#xD;
&#xD;
          -  History of alcohol or substance abuse&#xD;
&#xD;
          -  History of disease that could interfere with the test products or impede their&#xD;
             absorption&#xD;
&#xD;
          -  Subjects taking medications such as immune or upper respiratory tract infection&#xD;
             related drug or functional foods&#xD;
&#xD;
          -  Abnormal liver or kidney function tests&#xD;
&#xD;
          -  Pregnant or lactating women and heavy smokers&#xD;
&#xD;
          -  Being judged by the responsible physician of the local study center as unfit to&#xD;
             participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>39 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong Hwan Hwang, M.D. Ph. D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <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>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 18, 2017</last_update_submitted>
  <last_update_submitted_qc>January 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</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>ultrafiltered red ginseng</keyword>
  <keyword>hydrolyzed ginseng</keyword>
  <keyword>acute respiratory illness</keyword>
  <keyword>clinical trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03028077
org study id: CTCF2_2014_GN
nct id: NCT03028077
lead sponsor: 
has dmc: Yes
This study was conducted to investigate the effects of daily supplementation of GS-3K8 or
      GINst15 on acute respiratory illness (ARI) in healthy subjects.
This study was a 8 weeks, randomized, double-blind, placebo-controlled trial. Forty five
      subjects were randomly divided into GS-3K8 (Ultrafiltered red ginseng extract) or GINst15
      (Hydrolyzed ginseng extract) or placebo group. The primary clinical outcome measure was the
      incidence of ARI. The secondary clinical outcome measure was the development and duration of
      ARI symptoms.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Incidence rate of ARI (by questionnaire)
time frame: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
description: Incidence of ARI were assessed before and after intervention and followed up for 6 weeks after termination.
measure: Development of ARI symptoms (by questionnaire)
time frame: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
description: Development of ARI symptoms (score) were assessed before and after intervention and followed up for 6 weeks after termination.
measure: Duration of ARI symptoms (by questionnaire)
time frame: 18 weeks (intervention for 12 weeks, follow up for 6 weeks after termination)
description: Duration of ARI symptoms were assessed before and after intervention
arm group label: GS-3K8
arm group type: Experimental
description: GS-3K8 (6 cap/day, 500 mg/cap) for 12 weeks
arm group label: GINst15
arm group type: Experimental
description: GINst15 (6 cap/day, 500 mg/cap) for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for 12 weeks
intervention type: Dietary Supplement
intervention name: GS-3K8
description: GS-3K8 (ultrafiltered red ginseng extract) 1 g/day
arm group label: GS-3K8
intervention type: Dietary Supplement
intervention name: GINst15
description: GINst15 (hydrolyzed ginseng extract) 1 g/day
arm group label: GINst15
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo 1 g/day
arm group label: Placebo
criteria: 
gender: All
minimum age: 39 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jeong Hwan Hwang, M.D. Ph. D
role: Principal Investigator
affiliation: Chonbuk National University Hospital
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
mesh term: Respiratory Tract Infections
sharing ipd: Undecided