<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/NCT02211352</url>
  </required_header>
  <id_info>
    <org_study_id>GS302-100</org_study_id>
    <secondary_id>GS302-100</secondary_id>
    <nct_id>NCT02211352</nct_id>
  </id_info>
  <brief_title>Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension</brief_title>
  <acronym>KRGCBP</acronym>
  <official_title>Randomized Control Clinical Trial for Effect of Korean Red Ginseng on Central Blood Pressure in Patient With Essential Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daegu Catholic University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Korean Society of Ginseng</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Daegu Catholic University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease&#xD;
      central blood pressure in subjects with hypertension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants with hypertension who were treated with antihypertensive agents were randomly&#xD;
      assigned to an active (KRG 2 g/day) or a placebo treatment group in a double-blind cross over&#xD;
      manner.&#xD;
&#xD;
      Participants were not allowed to change their antihypertensive medications except safety&#xD;
      issue. Brachial systolic BP (SBP), diastolic BP (DBP), Central SBP and DBP will measured at&#xD;
      baseline,at 2 and 4 months.&#xD;
&#xD;
      Efficacy and safety data will be monitored by Daegu Catholic University Medical Center&#xD;
      Institutional Review Board and reported to the Korean Ginseng Society.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 2</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>central blood pressure change after treatment of Korea Red Ginseng</measure>
    <time_frame>baseline, 8 weeks and 16 weeks after treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>brachial systolic and diastolic blood pressure</measure>
    <time_frame>baseline, 8 week, 16 week.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Augumentation index</measure>
    <time_frame>baseline, 8 week, 16 week.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ESR(erythrocyte sedmentation rate)</measure>
    <time_frame>baseline, 8 week, 16 week.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP(C-reactive protein)</measure>
    <time_frame>baseline, 8 week, 16 week.</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>AST(Aspartate Aminotransferase)</measure>
    <time_frame>baseline, 8 week, 16 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Number of participants with adverse events</measure>
    <time_frame>baseline, 8 week, 16 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>fasting blood glucose</measure>
    <time_frame>baseline, 8 week, 16 week</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hb A1c(Hemoglobin A1c)</measure>
    <time_frame>baseline, 8 week, 16 week</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">58</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Active(Korean Red Ginseng) first group:</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo capsules</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Korean Red Ginseng Capsules</intervention_name>
    <description>Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week</description>
    <arm_group_label>Active(Korean Red Ginseng) first group:</arm_group_label>
    <other_name>Korean Red Ginseng (KRG) Capsule was manufactured</other_name>
    <other_name>from roots of a 6-year-old Panax ginseng Meyer.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week</description>
    <arm_group_label>Placebo capsules</arm_group_label>
    <other_name>Placebo of Kerea Red Ginseng(KRG) Capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Essential hypertension&#xD;
&#xD;
          -  diastolic blood pressure 100 mmHg or less and systolic blood pressure 160 mmHg or less&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary hypertension&#xD;
&#xD;
          -  Serum creatinin above 1.5 mg/dL&#xD;
&#xD;
          -  aspartate aminotransferase(AST) and alanine aminotransferaseALT above two times upper&#xD;
             normal limits&#xD;
&#xD;
          -  Uncontrolled diabetes (Hb A1c &lt; 9%)&#xD;
&#xD;
          -  Acute myocardial infarction or coronary artery disease intervention within six months&#xD;
&#xD;
          -  Moderate to severe congestive heart failure&#xD;
&#xD;
          -  HIV positive&#xD;
&#xD;
          -  Immunocompromized host&#xD;
&#xD;
          -  Allergy to Korean red ginseng&#xD;
&#xD;
          -  Pregnancy or plan to pregnancy&#xD;
&#xD;
          -  Alcohol or drug abuse&#xD;
&#xD;
          -  Attend to other clinical trial within 12 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin Bae Lee, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Daegu Catholic University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Daegu Catholic University Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>705-718</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>May 1, 2013</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 6, 2014</last_update_submitted>
  <last_update_submitted_qc>August 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Daegu Catholic University Medical Center</investigator_affiliation>
    <investigator_full_name>Jin Bae Lee</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>blood pressure, ginseng</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
    <mesh_term>Essential Hypertension</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/NCT02211352
org study id: GS302-100
secondary id: GS302-100
nct id: NCT02211352
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine Korean red ginseng (KRG)treatment could decrease
      central blood pressure in subjects with hypertension.
Participants with hypertension who were treated with antihypertensive agents were randomly
      assigned to an active (KRG 2 g/day) or a placebo treatment group in a double-blind cross over
      manner.

      Participants were not allowed to change their antihypertensive medications except safety
      issue. Brachial systolic BP (SBP), diastolic BP (DBP), Central SBP and DBP will measured at
      baseline,at 2 and 4 months.

      Efficacy and safety data will be monitored by Daegu Catholic University Medical Center
      Institutional Review Board and reported to the Korean Ginseng Society.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: central blood pressure change after treatment of Korea Red Ginseng
time frame: baseline, 8 weeks and 16 weeks after treatment
measure: brachial systolic and diastolic blood pressure
time frame: baseline, 8 week, 16 week.
measure: Augumentation index
time frame: baseline, 8 week, 16 week.
measure: ESR(erythrocyte sedmentation rate)
time frame: baseline, 8 week, 16 week.
measure: CRP(C-reactive protein)
time frame: baseline, 8 week, 16 week.
measure: AST(Aspartate Aminotransferase)
time frame: baseline, 8 week, 16 week
measure: Number of participants with adverse events
time frame: baseline, 8 week, 16 week
measure: fasting blood glucose
time frame: baseline, 8 week, 16 week
measure: Hb A1c(Hemoglobin A1c)
time frame: baseline, 8 week, 16 week
arm group label: Active(Korean Red Ginseng) first group:
arm group type: Active Comparator
description: Korean Red Ginseng Capsules 2g,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
arm group label: Placebo capsules
arm group type: Placebo Comparator
description: placebo Capsules(2g),daily, 8 week and than crossover to Korean Red Ginseng capsules(2g), daily 8week
intervention type: Drug
intervention name: Korean Red Ginseng Capsules
description: Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
arm group label: Active(Korean Red Ginseng) first group:
other name: Korean Red Ginseng (KRG) Capsule was manufactured
other name: from roots of a 6-year-old Panax ginseng Meyer.
intervention type: Drug
intervention name: Placebo
description: Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
arm group label: Placebo capsules
other name: Placebo of Kerea Red Ginseng(KRG) Capsule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jin Bae Lee, MD, PhD
role: Principal Investigator
affiliation: Daegu Catholic University Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Daegu Catholic University Medical Center
investigator full name: Jin Bae Lee
investigator title: Associate professor
mesh term: Hypertension
mesh term: Essential Hypertension