<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/NCT03260543</url>
  </required_header>
  <id_info>
    <org_study_id>GB-LFE-GP</org_study_id>
    <nct_id>NCT03260543</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Fermented Ginseng Powder on Liver Function</brief_title>
  <official_title>A 12-week, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Fermented Ginseng Powder on Liver Function</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was conducted to investigate the effects of daily supplementation of fermented&#xD;
      ginseng powder on improvement of Liver function.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human&#xD;
      trial to evaluate the efficacy and safety of fermented ginseng powder on improvement of Liver&#xD;
      function. The investigators measured ALT(Alanine Transaminase) profiles, Liver function&#xD;
      index, fatty liver grade, lipid metabolism index, total antioxidant capacity, imflammation&#xD;
      index, and Multidimensional Fatigue Scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</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 of ALT(Alanine Transaminase)</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Changes of ALT were assessed before and after the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of Liver function index</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Changes of AST were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of fatty liver grade</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Changes of fatty liver grade were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of lipid metabolism index</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Changes of lipid metabolism index were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of total antioxidant capacity</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Changes of total antioxidant capacity were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of imflammation index</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Changes of imflammation index were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Multidimensional Fatigue Scale</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Changes of Multidimensional Fatigue Scale were assessed before and after the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Fatty Liver, Nonalcoholic</condition>
  <arm_group>
    <arm_group_label>fermented ginseng powder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tablets (2 tablets/day, 125 mg &amp; 500 mg/day) 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>fermented ginseng powder</intervention_name>
    <description>tablets (2 tablets/day, 125 mg &amp; 500 mg/day) for 12 weeks.</description>
    <arm_group_label>fermented ginseng powder</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo for 12 weeks.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19-70 years with ALT 35-105 IU/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under antipsychotic drugs therapy within past 2 months&#xD;
&#xD;
          -  History of alcohol or substance abuse&#xD;
&#xD;
          -  Participation in any other clinical trials within past 2 months&#xD;
&#xD;
          -  Laboratory test by show the following results&#xD;
&#xD;
               -  Serum Creatinine &gt; 2.0 mg/dl&#xD;
&#xD;
          -  Pregnancy or breast feeding etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>70 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>54907</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>March 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>February 1, 2018</last_update_submitted>
  <last_update_submitted_qc>February 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2018</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>ginseng powder</keyword>
  <keyword>Fatty Liver</keyword>
  <keyword>Clinical Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatty Liver</mesh_term>
    <mesh_term>Non-alcoholic Fatty Liver Disease</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/NCT03260543
org study id: GB-LFE-GP
nct id: NCT03260543
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study was conducted to investigate the effects of daily supplementation of fermented
      ginseng powder on improvement of Liver function.
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of fermented ginseng powder on improvement of Liver
      function. The investigators measured ALT(Alanine Transaminase) profiles, Liver function
      index, fatty liver grade, lipid metabolism index, total antioxidant capacity, imflammation
      index, and Multidimensional Fatigue Scale.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes of ALT(Alanine Transaminase)
time frame: Baseline and 12 weeks
description: Changes of ALT were assessed before and after the intervention
measure: Changes of Liver function index
time frame: Baseline and 12 weeks
description: Changes of AST were assessed before and after the intervention
measure: Changes of fatty liver grade
time frame: Baseline and 12 weeks
description: Changes of fatty liver grade were assessed before and after the intervention
measure: Changes of lipid metabolism index
time frame: Baseline and 12 weeks
description: Changes of lipid metabolism index were assessed before and after the intervention
measure: Changes of total antioxidant capacity
time frame: Baseline and 12 weeks
description: Changes of total antioxidant capacity were assessed before and after the intervention
measure: Changes of imflammation index
time frame: Baseline and 12 weeks
description: Changes of imflammation index were assessed before and after the intervention
measure: Changes of Multidimensional Fatigue Scale
time frame: Baseline and 12 weeks
description: Changes of Multidimensional Fatigue Scale were assessed before and after the intervention
arm group label: fermented ginseng powder
arm group type: Experimental
description: tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for 12 weeks.
intervention type: Dietary Supplement
intervention name: fermented ginseng powder
description: tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.
arm group label: fermented ginseng powder
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo for 12 weeks.
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 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
mesh term: Fatty Liver
mesh term: Non-alcoholic Fatty Liver Disease
sharing ipd: Undecided