<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/NCT03828188</url>
  </required_header>
  <id_info>
    <org_study_id>JAR-FHL-RG2</org_study_id>
    <nct_id>NCT03828188</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level</brief_title>
  <official_title>A 12-week, Randomized, Double-blind, Placebo-controlled 2x2 Cross-over Design Human Trial to Evaluate the Efficacy and Safety of Red Ginseng Concentrated Powder on Improvement of Blood Triglyceride Level</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 Red Ginseng&#xD;
      Concentrated Powder on Improvement of Blood Triglyceride Level.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design&#xD;
      human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng&#xD;
      Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over&#xD;
      study.)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">May 8, 2019</completion_date>
  <primary_completion_date type="Actual">May 11, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of Fasting triglyceride</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of Fasting triglyceride was assessed before and after the intervention</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of Lipid metabolism indices</measure>
    <time_frame>30 weeks</time_frame>
    <description>Lipid metabolism indices were assessed before and after the intervention. The lipid metabolism index should be measured by collecting blood while keeping fasting for 12 hours or more. The inspection items are as follows.&#xD;
Total cholesterol, triglyceride, LDL-C, HDL-C, Non HDL-C, VLDL-C, free fatty acid, Apo A1, Apo B, hs-CRP&#xD;
Non HDL-C and VLDL-C are calculated by the calculation formula, and the first digit of the decimal point is indicated.&#xD;
Non HDL-C= Total cholesterol - HDL-C VLDL-C= Total cholesterol - (HDL-C + LDL-C)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Arteriosclerosis indices</measure>
    <time_frame>30 weeks</time_frame>
    <description>It is calculated by the calculation formula using the lipid metabolism indicator test item. Round off the third decimal place to the second decimal place. The items are as follows:&#xD;
* Total cholesterol/HDL-C, LDL-C/HDL-C, triglycerid/HDL-C, (Total cholesterol - HDL-C)/HDL-C, Apo B/Apo A1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Carnitine (Serum)</measure>
    <time_frame>30 weeks</time_frame>
    <description>Carnitine (Serum)[μmol/L] was assessed before and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of lipoprotein lipase</measure>
    <time_frame>30 weeks</time_frame>
    <description>lipoprotein lipase[ng/ml] was assessed before and after the intervention</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Hyperlipidemias</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Red Ginseng Concentrated Powder in 12 weeks → rest in 4 weeks → Placebo 12 weeks.&#xD;
Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)&#xD;
Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Placebo 12 weeks→ rest in 4 weeks → Red Ginseng Concentrated Powder in 12 weeks.&#xD;
Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)&#xD;
Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Red Ginseng Concentrated Powder</intervention_name>
    <description>Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</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>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 19-70 years with Triglyceride 120-200 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lipid lowering agent within past 6 months&#xD;
&#xD;
          -  Those with clinically significant severe cardiovascular, endocrine, immune,&#xD;
             respiratory, liver, biliary, renal and urinary tract, neuropsychiatry,&#xD;
             musculoskeletal, inflammatory and hematologic and gastrointestinal disorders&#xD;
&#xD;
          -  Persons with significant hypersensitivity reactions to ginseng and red ginseng&#xD;
&#xD;
          -  Those with a history of gastrointestinal disorders (ex, Crohn's disease) or&#xD;
             gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may&#xD;
             affect the absorption of a product for clinical trials&#xD;
&#xD;
          -  Those who have received antipsychotic medication within 2 months before screening&#xD;
&#xD;
          -  Those with a history of alcoholism or substance abuse&#xD;
&#xD;
          -  Those who participated in other clinical trials within 2 months before screening&#xD;
&#xD;
          -  Laboratory test by show the following results&#xD;
&#xD;
               -  Aspartate Transaminase(AST), Alanine Transaminase(ALT) &gt; Reference range 3 times&#xD;
                  upper limit&#xD;
&#xD;
               -  Serum Creatinine &gt; 2.0 mg/dL&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Those who doesn't accept the implementation of appropriate contraception of a&#xD;
             childbearing woman&#xD;
&#xD;
          -  Principal Investigator judged inappropriate for participation in study because of&#xD;
             Laboratory test result, 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>May 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 4, 2019</study_first_posted>
  <last_update_submitted>May 7, 2020</last_update_submitted>
  <last_update_submitted_qc>May 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2020</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>Red Ginseng Concentrated Powder</keyword>
  <keyword>Hyperlipidemias</keyword>
  <keyword>Clinical Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperlipidemias</mesh_term>
    <mesh_term>Hyperlipoproteinemias</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/NCT03828188
org study id: JAR-FHL-RG2
nct id: NCT03828188
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 Red Ginseng
      Concentrated Powder on Improvement of Blood Triglyceride Level.
This study was a 12-week, randomized, double-blind, placebo-controlled 2x2 cross-over design
      human trial. 50 subjects which of 25 by group were randomly divided into Red Ginseng
      Concentrated Powder and a placebo group.(A total of 100 subjects completed the 2x2 cross-over
      study.)
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes of Fasting triglyceride
time frame: 12 weeks
description: Changes of Fasting triglyceride was assessed before and after the intervention
measure: Changes of Lipid metabolism indices
time frame: 30 weeks
description: Lipid metabolism indices were assessed before and after the intervention. The lipid metabolism index should be measured by collecting blood while keeping fasting for 12 hours or more. The inspection items are as follows.
Total cholesterol, triglyceride, LDL-C, HDL-C, Non HDL-C, VLDL-C, free fatty acid, Apo A1, Apo B, hs-CRP
Non HDL-C and VLDL-C are calculated by the calculation formula, and the first digit of the decimal point is indicated.
Non HDL-C= Total cholesterol - HDL-C VLDL-C= Total cholesterol - (HDL-C + LDL-C)
measure: Changes of Arteriosclerosis indices
time frame: 30 weeks
description: It is calculated by the calculation formula using the lipid metabolism indicator test item. Round off the third decimal place to the second decimal place. The items are as follows:
* Total cholesterol/HDL-C, LDL-C/HDL-C, triglycerid/HDL-C, (Total cholesterol - HDL-C)/HDL-C, Apo B/Apo A1
measure: Changes of Carnitine (Serum)
time frame: 30 weeks
description: Carnitine (Serum)[μmol/L] was assessed before and after the intervention.
measure: Changes of lipoprotein lipase
time frame: 30 weeks
description: lipoprotein lipase[ng/ml] was assessed before and after the intervention
arm group label: group A
arm group type: Experimental
description: Red Ginseng Concentrated Powder in 12 weeks → rest in 4 weeks → Placebo 12 weeks.
Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
arm group label: group B
arm group type: Experimental
description: Placebo 12 weeks→ rest in 4 weeks → Red Ginseng Concentrated Powder in 12 weeks.
Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
Placebo: Red Ginseng Concentrated Powder: 2 times daily(4.9 g/day)
intervention type: Dietary Supplement
intervention name: Red Ginseng Concentrated Powder
description: Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.
arm group label: group A
arm group label: group B
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo for 12 weeks.
arm group label: group A
arm group label: group B
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: Hyperlipidemias
mesh term: Hyperlipoproteinemias
sharing ipd: Undecided