<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/NCT03775733</url>
  </required_header>
  <id_info>
    <org_study_id>GH-HG-HR</org_study_id>
    <nct_id>NCT03775733</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia</brief_title>
  <official_title>A 12 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate The Efficacy and Safety of Hydrolysed Red Ginseng Extract on Improvement of Hyperglycemia</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 hydrolysed&#xD;
      red ginseng extract on improvement of Hyperglycemia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty&#xD;
      subjects were randomly divided into Hydrolysed Red Ginseng extract or a placebo group.&#xD;
      Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were&#xD;
      assessed before and after the intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 7, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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 blood glucose</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of blood insulin</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of blood insulin during OGTT were assessed before and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of area under the curve of Glucose and Insulin</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of area under the curve of Glucose and Insulin were assessed before and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Homeostatic model assessment-insulin resistance</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of Homeostatic model assessment-beta-cell</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of HbA1c</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of HbA1c(%) were assessed before and after the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of C-peptide</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of C-peptide(ng/ml) were assessed before and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of lipid profile</measure>
    <time_frame>12 weeks</time_frame>
    <description>Changes of lipid profile were assessed before and after the intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Hyperglycemia</condition>
  <arm_group>
    <arm_group_label>Hydrolysed red ginseng extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hydrolysed red ginseng extract 2.4g/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>Hydrolysed Red Ginseng Extract</intervention_name>
    <description>Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.</description>
    <arm_group_label>Hydrolysed red ginseng extract</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 19-80 years with fasting glucose 100-140 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Weight less than 48 kg or weight decreased by more than 10% within past 3 months&#xD;
&#xD;
          -  Have clinically significant acute or chronic cardiovascular system, endocrine system,&#xD;
             immune system, respiratory system, hepatic biliary system, kidney and Urinary system,&#xD;
             neuropsychiatry, musculoskeletal, inflammatory and hematologic malignancies,&#xD;
             gastrointestinal disorders, etc.&#xD;
&#xD;
          -  Hypoglycemic agent, Obesity medicine, Lipid lowering agent within past 3 months&#xD;
&#xD;
          -  Blood sugar improvement or healthy functional food within past 1 month&#xD;
&#xD;
          -  Under antipsychotic medication 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;
               -  aspartate aminotransferase, alanine aminotransferase &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;
          -  If a woman of childbearing doesn't accept the implementation of appropriate&#xD;
             contraception&#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>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>54907</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Soo-Wan Chae, MD., PhD</last_name>
      <phone>82-63-259-3040</phone>
      <email>swchae@jbctc.org</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</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>Hydrolysed red ginseng extract</keyword>
  <keyword>Glucose</keyword>
  <keyword>Clinical Trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperglycemia</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/NCT03775733
org study id: GH-HG-HR
nct id: NCT03775733
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 hydrolysed
      red ginseng extract on improvement of Hyperglycemia.
This study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. Twenty
      subjects were randomly divided into Hydrolysed Red Ginseng extract or a placebo group.
      Fasting and postprandial glucose profiles during oral glucose tolerance test (OGTT) were
      assessed before and after the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes of blood glucose
time frame: 12 weeks
description: Changes of fasting and postprandial glucose during OGTT were assessed before and after the intervention.
measure: Changes of blood insulin
time frame: 12 weeks
description: Changes of blood insulin during OGTT were assessed before and after the intervention.
measure: Changes of area under the curve of Glucose and Insulin
time frame: 12 weeks
description: Changes of area under the curve of Glucose and Insulin were assessed before and after the intervention.
measure: Changes of Homeostatic model assessment-insulin resistance
time frame: 12 weeks
description: Changes of physiological parameter{Homeostatic model assessment-insulin resistance(mg/dl)} were assessed before and after the intervention.
measure: Changes of Homeostatic model assessment-beta-cell
time frame: 12 weeks
description: Changes of physiological parameter{Homeostatic model assessment-beta-cell(mg/dl)} were assessed before and after the intervention
measure: Changes of HbA1c
time frame: 12 weeks
description: Changes of HbA1c(%) were assessed before and after the intervention
measure: Changes of C-peptide
time frame: 12 weeks
description: Changes of C-peptide(ng/ml) were assessed before and after the intervention.
measure: Changes of lipid profile
time frame: 12 weeks
description: Changes of lipid profile were assessed before and after the intervention.
arm group label: Hydrolysed red ginseng extract
arm group type: Experimental
description: Hydrolysed red ginseng extract 2.4g/day for 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo for 12 weeks
intervention type: Dietary Supplement
intervention name: Hydrolysed Red Ginseng Extract
description: Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.
arm group label: Hydrolysed red ginseng extract
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: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
status: Recruiting
contact: 
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: Hyperglycemia