<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/NCT03775837</url>
  </required_header>
  <id_info>
    <org_study_id>02-2018-031</org_study_id>
    <nct_id>NCT03775837</nct_id>
  </id_info>
  <brief_title>Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults</brief_title>
  <official_title>Effect of Panax Ginseng C.A. Mey Extract on Liver Function in Adults: a Randomized, Double-blinded, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pusan National University Yangsan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Yangsan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators conduct a randomized, double-blind, placebo-controlled study to investigate&#xD;
      the effects of Panax Ginseng C.A. Mey Extract on liver function in adults for 8 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous studies have indicated that Panax Ginseng C.A. Mey Extract may have the ability to&#xD;
      improve liver function. Therefore, the investigators conduct a randomized, double-blind,&#xD;
      placebo-controlled study to investigate the effects of the Panax Ginseng C.A. Mey Extract on&#xD;
      liver function in adults; the safety of the compound are also evaluate. The Investigators&#xD;
      examine AST, ALT, GGT, and other metabolic parameters at baseline, as well as after 4 and 8&#xD;
      weeks of intervention. Sixty adults were administered either 600 mg of Panax Ginseng C.A. Mey&#xD;
      Extract or a placebo each day for 8 weeks;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Alanine aminotransferase</measure>
    <time_frame>8 weeks</time_frame>
    <description>Alanine aminotransferase</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Aspartate aminotransferase</measure>
    <time_frame>8 weeks</time_frame>
    <description>Aspartate aminotransferase</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gamma-glutamyl transferase</measure>
    <time_frame>8 weeks</time_frame>
    <description>Gamma-glutamyl transferase</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Liver Diseases</condition>
  <arm_group>
    <arm_group_label>Panax Ginseng C.A. Mey Extract group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group takes Panax Ginseng C.A. Mey Extract for 8 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group takes placebo for 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Panax Ginseng C.A. Mey Extract group</intervention_name>
    <description>This group takes Panax Ginseng C.A. Mey Extract for 8 weeks</description>
    <arm_group_label>Panax Ginseng C.A. Mey Extract group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo group</intervention_name>
    <description>This group takes placebo for 8 weeks</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ALT ranging from upper limit of reference to three times of upper limit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal liver or renal function (i.e., serum aminotransferase activity &gt; 3 times of&#xD;
             upper limit of reference range and serum creatinine concentrations &gt; 1.2 mg/dL)&#xD;
&#xD;
          -  Diabetes (diagnosed clinically or fasting glucose level &gt; 126 mg/dL)&#xD;
&#xD;
          -  History of viral hepatitis or cancer&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  History of serious cardiac disease such as angina or myocardial infarction&#xD;
&#xD;
          -  History of gastrectomy&#xD;
&#xD;
          -  History of medication for psychiatric disease&#xD;
&#xD;
          -  Administration of oriental medicine including herbs within the past 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang Yeoup Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Yangsan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sang Yeoup Lee</last_name>
    <phone>360-2860</phone>
    <phone_ext>055</phone_ext>
    <email>saylee@pnu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ye Li Lee</last_name>
    <phone>360-2860</phone>
    <phone_ext>055</phone_ext>
    <email>yeri1230@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Integrated Research Institute for Natural Ingredients and Functional Foods</name>
      <address>
        <city>Yangsan</city>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang Yeoup Lee, MD</last_name>
      <phone>82-55-360-2860</phone>
      <email>saylee@pnu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>February 1, 2023</last_update_submitted>
  <last_update_submitted_qc>February 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University Yangsan Hospital</investigator_affiliation>
    <investigator_full_name>Sang Yeoup Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03775837
org study id: 02-2018-031
nct id: NCT03775837
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate
      the effects of Panax Ginseng C.A. Mey Extract on liver function in adults for 8 weeks.
Previous studies have indicated that Panax Ginseng C.A. Mey Extract may have the ability to
      improve liver function. Therefore, the investigators conduct a randomized, double-blind,
      placebo-controlled study to investigate the effects of the Panax Ginseng C.A. Mey Extract on
      liver function in adults; the safety of the compound are also evaluate. The Investigators
      examine AST, ALT, GGT, and other metabolic parameters at baseline, as well as after 4 and 8
      weeks of intervention. Sixty adults were administered either 600 mg of Panax Ginseng C.A. Mey
      Extract or a placebo each day for 8 weeks;
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Alanine aminotransferase
time frame: 8 weeks
description: Alanine aminotransferase
measure: Aspartate aminotransferase
time frame: 8 weeks
description: Aspartate aminotransferase
measure: Gamma-glutamyl transferase
time frame: 8 weeks
description: Gamma-glutamyl transferase
arm group label: Panax Ginseng C.A. Mey Extract group
arm group type: Experimental
description: This group takes Panax Ginseng C.A. Mey Extract for 8 weeks
arm group label: Placebo group
arm group type: Placebo Comparator
description: This group takes placebo for 8 weeks
intervention type: Dietary Supplement
intervention name: Panax Ginseng C.A. Mey Extract group
description: This group takes Panax Ginseng C.A. Mey Extract for 8 weeks
arm group label: Panax Ginseng C.A. Mey Extract group
intervention type: Dietary Supplement
intervention name: Placebo group
description: This group takes placebo for 8 weeks
arm group label: Placebo group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sang Yeoup Lee
role: Principal Investigator
affiliation: Pusan National University Yangsan Hospital
last name: Sang Yeoup Lee
phone: 360-2860
phone ext: 055
email: saylee@pnu.edu
last name: Ye Li Lee
phone: 360-2860
phone ext: 055
email: yeri1230@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Pusan National University Yangsan Hospital
investigator full name: Sang Yeoup Lee
investigator title: Professor
mesh term: Liver Diseases