<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/NCT01689701</url>
  </required_header>
  <id_info>
    <org_study_id>PKU-EG-ECKL</org_study_id>
    <nct_id>NCT01689701</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Hizikia Fusiformis Extract in Subjects Showing Erosive Gastritis</brief_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 double-blind parallel study in a group of Subjects Showing&#xD;
      Erosive Gastritis who were given Hizikia Fusiformis Extract over a period of 4 weeks.&#xD;
      Endoscopic observations were performed before and 4 weeks after the treatment, and the cure&#xD;
      and improvement rates were investigated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2011</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">August 2011</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 in Erosions</measure>
    <time_frame>4 weeks</time_frame>
    <description>Erosions was measured in study visit 1(0 week) and visit 3(4 week). Gastric erosion occurs when the mucous membrane lining the stomach becomes inflamed.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in Score of Erosions</measure>
    <time_frame>4 weeks</time_frame>
    <description>Score of erosions(score 1-4) was measured in study visit 1(0 week) and visit 3(4 week).&#xD;
Score of erosions is assigned a score of between 1 (Erosion = 0) to 4 (Erosion ≥ 6) and summed to form a score ranging from 1 (best) to 4 (worst).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in Subjects' Symptoms Total Score</measure>
    <time_frame>4 weeks</time_frame>
    <description>Subjects' symptoms total score(score 0-24) was measured in study visit 1(0 week) and visit 3(4 week).&#xD;
The original index consists of 8 Questions. Individual question response is assigned a score of between 0 (none) to 3 (moderate) and summed to form a score ranging from 0 (best) to 24 (worst).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Gastrin</measure>
    <time_frame>4 weeks</time_frame>
    <description>Gastrin was measured in study visit 1(0 week) and visit 3(4 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in PepsinogenⅠ</measure>
    <time_frame>4 weeks</time_frame>
    <description>PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in PepsinogenⅡ</measure>
    <time_frame>4 weeks</time_frame>
    <description>PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Pepsinogen Ⅰ/Ⅱ Ratio</measure>
    <time_frame>4 weeks</time_frame>
    <description>Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in Hs-CRP(High Sensitivity C-reactive Protein)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Hs-CRP(High Sensitivity C-reactive Protein) was measured in study visit 1(0 week) and visit 3(4 week).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Erosive Gastritis</condition>
  <arm_group>
    <arm_group_label>Hizikia Fusiformis extract</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Hizikia Fusiformis extract</intervention_name>
    <description>Hizikia Fusiformis extract(1.3g/d)</description>
    <arm_group_label>Hizikia Fusiformis extract</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo(1.3g/d)</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Males and females 19-70 years old&#xD;
&#xD;
          -  Subjects Showing Erosive Gastritis (endoscopy)&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed of gastrointestinal disease such as ulcer, cancer within 1 months&#xD;
&#xD;
          -  Allergic or hypersensitive to any of the ingredients in the test products&#xD;
&#xD;
          -  History of disease that could interfere with the test products or impede their&#xD;
             absorption, such as gastrointestinal disease or gastrointestinal surgery&#xD;
&#xD;
          -  Taken antibiotics and stomach medicines such as steroid, bismuth compound and proton&#xD;
             pump inhibitor within 1 months&#xD;
&#xD;
          -  Participation in any other clinical trials within past 2 months&#xD;
&#xD;
          -  Laboratory test, medical or psychological conditions deemed by the investigators to&#xD;
             interfere with successful participation in the study&#xD;
&#xD;
          -  Pregnant or lactating women 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>
  <overall_official>
    <last_name>Sang-Wook Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chonbuk National University Hospital</affiliation>
  </overall_official>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>September 25, 2012</results_first_submitted>
  <results_first_submitted_qc>August 20, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">September 20, 2019</results_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</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</investigator_title>
  </responsible_party>
  <keyword>Erosive Gastritis</keyword>
  <keyword>Hizikia Fusiformis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastritis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study subjects were recruited from Clinical Trial Center for Functional Food in Chonbuk National University Hospital during the 2011. Only those subjects who were Subjects Showing Erosive Gastritis and were not diagnosed with any disease were included in this study.</recruitment_details>
      <pre_assignment_details>Among the 79 subjets screened, 25 subjects had endoscopy and/or laboratory tests results that were in the exclusion criteria category, hence they were excluded from the study.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Hizikia Fusiformis Extract</title>
          <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Hizikia Fusiformis Extract</title>
          <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="54"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="39.1" spread="11.9"/>
                    <measurement group_id="B2" value="38.7" spread="10.0"/>
                    <measurement group_id="B3" value="38.9" spread="10.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="22"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Changes in Erosions</title>
        <description>Erosions was measured in study visit 1(0 week) and visit 3(4 week). Gastric erosion occurs when the mucous membrane lining the stomach becomes inflamed.</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hizikia Fusiformis Extract</title>
            <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Erosions</title>
          <description>Erosions was measured in study visit 1(0 week) and visit 3(4 week). Gastric erosion occurs when the mucous membrane lining the stomach becomes inflamed.</description>
          <units>erosions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.36" spread="2.48"/>
                    <measurement group_id="O2" value="3.38" spread="2.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.32" spread="2.10"/>
                    <measurement group_id="O2" value="2.43" spread="3.28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Changes in Score of Erosions</title>
        <description>Score of erosions(score 1-4) was measured in study visit 1(0 week) and visit 3(4 week).&#xD;
Score of erosions is assigned a score of between 1 (Erosion = 0) to 4 (Erosion ≥ 6) and summed to form a score ranging from 1 (best) to 4 (worst).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hizikia Fusiformis Extract</title>
            <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Score of Erosions</title>
          <description>Score of erosions(score 1-4) was measured in study visit 1(0 week) and visit 3(4 week).&#xD;
Score of erosions is assigned a score of between 1 (Erosion = 0) to 4 (Erosion ≥ 6) and summed to form a score ranging from 1 (best) to 4 (worst).</description>
          <units>Scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.00" spread="0.76"/>
                    <measurement group_id="O2" value="2.71" spread="0.78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.23" spread="0.92"/>
                    <measurement group_id="O2" value="2.05" spread="1.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Subjects' Symptoms Total Score</title>
        <description>Subjects' symptoms total score(score 0-24) was measured in study visit 1(0 week) and visit 3(4 week).&#xD;
The original index consists of 8 Questions. Individual question response is assigned a score of between 0 (none) to 3 (moderate) and summed to form a score ranging from 0 (best) to 24 (worst).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hizikia Fusiformis Extract</title>
            <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Subjects' Symptoms Total Score</title>
          <description>Subjects' symptoms total score(score 0-24) was measured in study visit 1(0 week) and visit 3(4 week).&#xD;
The original index consists of 8 Questions. Individual question response is assigned a score of between 0 (none) to 3 (moderate) and summed to form a score ranging from 0 (best) to 24 (worst).</description>
          <units>Units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.77" spread="2.56"/>
                    <measurement group_id="O2" value="3.90" spread="4.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.77" spread="3.18"/>
                    <measurement group_id="O2" value="2.57" spread="3.37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Gastrin</title>
        <description>Gastrin was measured in study visit 1(0 week) and visit 3(4 week).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hizikia Fusiformis Extract</title>
            <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Gastrin</title>
          <description>Gastrin was measured in study visit 1(0 week) and visit 3(4 week).</description>
          <units>pg/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37.36" spread="16.43"/>
                    <measurement group_id="O2" value="36.44" spread="16.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="32.05" spread="15.27"/>
                    <measurement group_id="O2" value="27.61" spread="10.86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in PepsinogenⅠ</title>
        <description>PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hizikia Fusiformis Extract</title>
            <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in PepsinogenⅠ</title>
          <description>PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).</description>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="50.15" spread="14.78"/>
                    <measurement group_id="O2" value="54.72" spread="16.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55.28" spread="19.08"/>
                    <measurement group_id="O2" value="57.96" spread="19.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in PepsinogenⅡ</title>
        <description>PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hizikia Fusiformis Extract</title>
            <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in PepsinogenⅡ</title>
          <description>PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).</description>
          <units>ng/ml</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.40" spread="8.38"/>
                    <measurement group_id="O2" value="12.65" spread="7.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.39" spread="10.16"/>
                    <measurement group_id="O2" value="13.66" spread="8.09"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Pepsinogen Ⅰ/Ⅱ Ratio</title>
        <description>Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hizikia Fusiformis Extract</title>
            <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Pepsinogen Ⅰ/Ⅱ Ratio</title>
          <description>Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.66" spread="1.86"/>
                    <measurement group_id="O2" value="5.17" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.56" spread="1.84"/>
                    <measurement group_id="O2" value="5.07" spread="1.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Changes in Hs-CRP(High Sensitivity C-reactive Protein)</title>
        <description>Hs-CRP(High Sensitivity C-reactive Protein) was measured in study visit 1(0 week) and visit 3(4 week).</description>
        <time_frame>4 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Hizikia Fusiformis Extract</title>
            <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
          </group>
        </group_list>
        <measure>
          <title>Changes in Hs-CRP(High Sensitivity C-reactive Protein)</title>
          <description>Hs-CRP(High Sensitivity C-reactive Protein) was measured in study visit 1(0 week) and visit 3(4 week).</description>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
                <count group_id="O2" value="21"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.63" spread="1.24"/>
                    <measurement group_id="O2" value="0.16" spread="0.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.23" spread="0.4"/>
                    <measurement group_id="O2" value="0.75" spread="2.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Hizikia Fusiformis Extract</title>
          <description>Hizikia Fusiformis extract(1.3g/d) for 12weeks&#xD;
Hizikia Fusiformis extract: Hizikia Fusiformis by Ethanol and extracted with concentrated</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo(1.3g/day) for 4weeks&#xD;
Placebo : Amount and calorie of placebo are same with Hizikia Fusiformis extract.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Sang-Wook Kim, MD</name_or_title>
      <organization>Clinical Trial Center for Functional Foods; Chonbuk National University Hospital</organization>
      <phone>82-63-276-8284</phone>
      <email>clickm@jbnu.ac.kr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01689701
org study id: PKU-EG-ECKL
nct id: NCT01689701
lead sponsor: 
has dmc: Yes
The investigators performed a double-blind parallel study in a group of Subjects Showing
      Erosive Gastritis who were given Hizikia Fusiformis Extract over a period of 4 weeks.
      Endoscopic observations were performed before and 4 weeks after the treatment, and the cure
      and improvement rates were investigated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Changes in Erosions
time frame: 4 weeks
description: Erosions was measured in study visit 1(0 week) and visit 3(4 week). Gastric erosion occurs when the mucous membrane lining the stomach becomes inflamed.
measure: Changes in Score of Erosions
time frame: 4 weeks
description: Score of erosions(score 1-4) was measured in study visit 1(0 week) and visit 3(4 week).
Score of erosions is assigned a score of between 1 (Erosion = 0) to 4 (Erosion ≥ 6) and summed to form a score ranging from 1 (best) to 4 (worst).
measure: Changes in Subjects' Symptoms Total Score
time frame: 4 weeks
description: Subjects' symptoms total score(score 0-24) was measured in study visit 1(0 week) and visit 3(4 week).
The original index consists of 8 Questions. Individual question response is assigned a score of between 0 (none) to 3 (moderate) and summed to form a score ranging from 0 (best) to 24 (worst).
measure: Changes in Gastrin
time frame: 4 weeks
description: Gastrin was measured in study visit 1(0 week) and visit 3(4 week).
measure: Changes in PepsinogenⅠ
time frame: 4 weeks
description: PepsinogenⅠ was measured in study visit 1(0 week) and visit 3(4 week).
measure: Changes in PepsinogenⅡ
time frame: 4 weeks
description: PepsinogenⅡ was measured in study visit 1(0 week) and visit 3(4 week).
measure: Changes in Pepsinogen Ⅰ/Ⅱ Ratio
time frame: 4 weeks
description: Pepsinogen Ⅰ/Ⅱ ratio was measured in study visit 1(0 week) and visit 3(4 week).
measure: Changes in Hs-CRP(High Sensitivity C-reactive Protein)
time frame: 4 weeks
description: Hs-CRP(High Sensitivity C-reactive Protein) was measured in study visit 1(0 week) and visit 3(4 week).
arm group label: Hizikia Fusiformis extract
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Dietary Supplement
intervention name: Hizikia Fusiformis extract
description: Hizikia Fusiformis extract(1.3g/d)
arm group label: Hizikia Fusiformis extract
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo(1.3g/d)
arm group label: Placebo
criteria: 
gender: All
minimum age: 19 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sang-Wook Kim, MD
role: Principal Investigator
affiliation: Chonbuk National University Hospital
responsible party type: Principal Investigator
investigator affiliation: Chonbuk National University Hospital
investigator full name: Soo-Wan Chae
investigator title: Principal Investigator
mesh term: Gastritis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 