<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/NCT03277833</url>
  </required_header>
  <id_info>
    <org_study_id>CBU-STR-DOLWOE</org_study_id>
    <nct_id>NCT03277833</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain</brief_title>
  <official_title>Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators performed a 8-week, randomized, double-blind, placebo-controlled human&#xD;
      trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on&#xD;
      alleviation of chronic stress-induced strain. The investigators measured decrement of body&#xD;
      fat parameters, State&amp;Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety&#xD;
      Inventory(HAM-A), and monitored their blood pressure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Change in score of State&amp;Trait version of STAI</measure>
    <time_frame>Baseline and 8 weeks</time_frame>
    <description>Score of State&amp;Trait version of STAI was measured in study screening and visit 3(8 week).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Blood Norepinephrine Level</measure>
    <time_frame>Baseline and 8 week</time_frame>
    <description>Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Blood Cortisol Level</measure>
    <time_frame>Baseline and 8 week</time_frame>
    <description>Blood cortisol level was measured in study visit 1(0 week) and visit 3(8 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in score of Beck Anxiety Inventory</measure>
    <time_frame>Baseline and 8 week</time_frame>
    <description>Score of Beck Anxiety Inventory was measured in study visit 1(0 week) and visit 3(8 week).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Chronic Stress-Induced Strain</condition>
  <arm_group>
    <arm_group_label>Gynostemma Pentaphyllum(Dungkulcha) Extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)</intervention_name>
    <description>Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design</description>
    <arm_group_label>Gynostemma Pentaphyllum(Dungkulcha) Extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, parallel design</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Age 20-65 years with chronic stress( S-STAI score 40~60)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  excessive physically chronic fatigue&#xD;
&#xD;
          -  Subjects taking antidepressants, anxiolytics, hypnotics within the last 2 months prior&#xD;
             to the study&#xD;
&#xD;
          -  Cardiovascular disease&#xD;
&#xD;
          -  Allergic or hypersensitive to any of the ingredients in the test products&#xD;
&#xD;
          -  History of reaction to any of the test products or of gastrointestinal diseases such&#xD;
             as Crohn's disease or gastrointestinal surgery&#xD;
&#xD;
          -  Participation in any other clinical trials within past 2 months&#xD;
&#xD;
          -  Renal disease&#xD;
&#xD;
          -  Abnormal hepatic function&#xD;
&#xD;
          -  Laboratory test, medical or psychological conditions deemed by the investigators to&#xD;
             interfere with successful participation in the study&#xD;
&#xD;
          -  History of alcohol or substance abuse&#xD;
&#xD;
          -  Pregnancy or lacting women etc.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>May 13, 2016</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 11, 2017</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sprains and Strains</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03277833
org study id: CBU-STR-DOLWOE
nct id: NCT03277833
lead sponsor: 
has dmc: Yes
The investigators performed a 8-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on
      alleviation of chronic stress-induced strain. The investigators measured decrement of body
      fat parameters, State&Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety
      Inventory(HAM-A), and monitored their blood pressure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Change in score of State&Trait version of STAI
time frame: Baseline and 8 weeks
description: Score of State&Trait version of STAI was measured in study screening and visit 3(8 week).
measure: Change of Blood Norepinephrine Level
time frame: Baseline and 8 week
description: Blood norepinephrine level was measured in study visit 1(0 week) and visit 3(8 week).
measure: Change of Blood Cortisol Level
time frame: Baseline and 8 week
description: Blood cortisol level was measured in study visit 1(0 week) and visit 3(8 week).
measure: Change in score of Beck Anxiety Inventory
time frame: Baseline and 8 week
description: Score of Beck Anxiety Inventory was measured in study visit 1(0 week) and visit 3(8 week).
arm group label: Gynostemma Pentaphyllum(Dungkulcha) Extract
arm group type: Experimental
description: Gynostemma Pentaphyllum(Dungkulcha) Extract (400mg/d)
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Dietary Supplement
intervention name: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)
description: Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design
arm group label: Gynostemma Pentaphyllum(Dungkulcha) Extract
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo, parallel design
arm group label: Placebo
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
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: Sprains and Strains
sharing ipd: No