<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/NCT01664156</url>
  </required_header>
  <id_info>
    <org_study_id>KHNMC-OH-IRB 2012-004</org_study_id>
    <nct_id>NCT01664156</nct_id>
  </id_info>
  <brief_title>Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet</brief_title>
  <official_title>Effect of Korean Red Ginseng on Women With Cold Hypersensitivity of Hands and Feet : a Randomized, Double-blind, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Korean Society of Ginseng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Korean Society of Ginseng</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      1. Objectives&#xD;
&#xD;
             1. to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet&#xD;
                in women&#xD;
&#xD;
             2. to establish scientific evidence for the use of Korean red ginseng by investigating&#xD;
                changes of infrared thermography&#xD;
&#xD;
        2. Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity&#xD;
           of hands and feet more effectively than placebo after 8 weeks administration of&#xD;
           interventions- Korean red ginseng or the placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design&#xD;
&#xD;
        -  This trial is a randomized, double blind, placebo controlled trial with 80 patients.&#xD;
&#xD;
        -  The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul,&#xD;
           Korea.&#xD;
&#xD;
        -  Participants will take Korean red ginseng or placebo for 8 weeks and will be followed up&#xD;
           during 4 weeks.&#xD;
&#xD;
        -  During the administration period, 6 capsules 2 times a day (1h after breakfast and&#xD;
           dinner) of Korean red ginseng or its placebo will be provided.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <phase>Phase 4</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of the infrared thermography of cold hypersensitivity on hands</measure>
    <time_frame>baseline and 8 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The change of the infrared thermography of cold hypersensitivity on feet</measure>
    <time_frame>baseline and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet</measure>
    <time_frame>baseline and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of cold stress test</measure>
    <time_frame>baseline and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of Distal-Dorsal Difference</measure>
    <time_frame>baseline and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of Heart Rate Variability</measure>
    <time_frame>baseline and 8 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The change of 36-Item Short Form Health Survey</measure>
    <time_frame>baseline, 8 weeks, and 12 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Cold Hypersensitivity</condition>
  <arm_group>
    <arm_group_label>Korean red ginseng</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will receive Korean red ginseng(Korean Red Ginseng Powder Capsule®; Korea Ginseng Corporation, Daejeon, Korea). Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo Korean red ginseng capsule contain cornstarch powder with the same color and taste as Korean red ginseng. Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Korean red ginseng</intervention_name>
    <description>Korean red ginseng is a steamed form of Panax ginseng with preserved major constituents. It has been shown to possess more biological activity than panax ginseng.</description>
    <arm_group_label>Korean red ginseng</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female aged 16 to 60 years&#xD;
&#xD;
          2. Women complaining cold hypersensitivity on hands and feet&#xD;
&#xD;
          3. Thermal deviation between the palm and the upper arm is higher than 0.3℃&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Skin ailment, radiculopathy, thrombophlebitis, and injuries affecting infrared&#xD;
             thermography&#xD;
&#xD;
          2. Alcohol abuse and alcoholic&#xD;
&#xD;
          3. History of cancer within 5 years&#xD;
&#xD;
          4. Severe depression&#xD;
&#xD;
          5. Hypertension and diabetes&#xD;
&#xD;
          6. Pregnancy or breastfeeding&#xD;
&#xD;
          7. Abnormal finding from blood test at screening visit&#xD;
&#xD;
          8. Allergic to Korean red ginseng&#xD;
&#xD;
          9. Took herbal medicine or health functional food within a week Participated another&#xD;
             clinical trials within 3 months&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>JIN-MOO LEE, Ph. D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kyung Hee University Hospital at Gangdong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kyung Hee University Hospital at Gangdong</name>
      <address>
        <city>Seoul</city>
        <state>Gangdong-gu</state>
        <zip>134 727</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Hur YM, Chae JH, Chung KW, Kim JJ, Jeong HU, Kim JW, Seo SY, Kim KS. Feeling of cold hands and feet is a highly heritable phenotype. Twin Res Hum Genet. 2012 Apr;15(2):166-9. doi: 10.1375/twin.15.2.166.</citation>
    <PMID>22856358</PMID>
  </reference>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>August 8, 2012</study_first_submitted>
  <study_first_submitted_qc>August 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>March 12, 2014</last_update_submitted>
  <last_update_submitted_qc>March 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kyung Hee University Hospital at Gangdong</investigator_affiliation>
    <investigator_full_name>JIN-MOO LEE</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Cold hypersensitivity</keyword>
  <keyword>Korean red ginseng</keyword>
  <keyword>Infrared thermography</keyword>
  <keyword>Cold stress test</keyword>
  <keyword>Distal-dorsal difference</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cryopyrin-Associated Periodic Syndromes</mesh_term>
    <mesh_term>Hypersensitivity</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/NCT01664156
org study id: KHNMC-OH-IRB 2012-004
nct id: NCT01664156
lead sponsor: 
has dmc: Yes
1. Objectives

             1. to verify effect of Korean red ginseng on cold hypersensitivity of hands and feet
                in women

             2. to establish scientific evidence for the use of Korean red ginseng by investigating
                changes of infrared thermography

        2. Hypothesis The hypothesis is that Korean red ginseng will reduce cold hypersensitivity
           of hands and feet more effectively than placebo after 8 weeks administration of
           interventions- Korean red ginseng or the placebo.
Design

        -  This trial is a randomized, double blind, placebo controlled trial with 80 patients.

        -  The trial will be implemented at Kyung Hee University Hospital at Gangdong in Seoul,
           Korea.

        -  Participants will take Korean red ginseng or placebo for 8 weeks and will be followed up
           during 4 weeks.

        -  During the administration period, 6 capsules 2 times a day (1h after breakfast and
           dinner) of Korean red ginseng or its placebo will be provided.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: The change of the infrared thermography of cold hypersensitivity on hands
time frame: baseline and 8 weeks
measure: The change of the infrared thermography of cold hypersensitivity on feet
time frame: baseline and 8 weeks
measure: The change of the Visual Analogue Scale of cold hypersensitivity on hands and feet
time frame: baseline and 8 weeks
measure: The change of cold stress test
time frame: baseline and 8 weeks
measure: The change of Distal-Dorsal Difference
time frame: baseline and 8 weeks
measure: The change of Heart Rate Variability
time frame: baseline and 8 weeks
measure: The change of 36-Item Short Form Health Survey
time frame: baseline, 8 weeks, and 12 weeks
arm group label: Korean red ginseng
arm group type: Experimental
description: The patients will receive Korean red ginseng(Korean Red Ginseng Powder Capsule®; Korea Ginseng Corporation, Daejeon, Korea). Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).
arm group label: placebo
arm group type: Placebo Comparator
description: Placebo Korean red ginseng capsule contain cornstarch powder with the same color and taste as Korean red ginseng. Patients will be requested to take 6 capsules 2 times a day (1h after breakfast and dinner).
intervention type: Drug
intervention name: Korean red ginseng
description: Korean red ginseng is a steamed form of Panax ginseng with preserved major constituents. It has been shown to possess more biological activity than panax ginseng.
arm group label: Korean red ginseng
intervention type: Drug
intervention name: Placebo
arm group label: placebo
criteria: 
gender: Female
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: No
last name: JIN-MOO LEE, Ph. D
role: Principal Investigator
affiliation: Kyung Hee University Hospital at Gangdong
facility: 
country: Korea, Republic of
citation: Hur YM, Chae JH, Chung KW, Kim JJ, Jeong HU, Kim JW, Seo SY, Kim KS. Feeling of cold hands and feet is a highly heritable phenotype. Twin Res Hum Genet. 2012 Apr;15(2):166-9. doi: 10.1375/twin.15.2.166.
PMID: 22856358
responsible party type: Principal Investigator
investigator affiliation: Kyung Hee University Hospital at Gangdong
investigator full name: JIN-MOO LEE
investigator title: Professor
mesh term: Cryopyrin-Associated Periodic Syndromes
mesh term: Hypersensitivity