<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/NCT02213562</url>
  </required_header>
  <id_info>
    <org_study_id>eki-997</org_study_id>
    <nct_id>NCT02213562</nct_id>
  </id_info>
  <brief_title>Effect of Chrysanthemum Flower Oil and Its Dose-dependency on Hyperuricemia</brief_title>
  <official_title>A Randomized, Double-blind, Parallel Group Study to Evaluate the Effect of Chrysanthemum Flower Oil and Its Dose-dependency in Subjects With Hyperuricemia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hiroshima University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kaneka Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hiroshima University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum&#xD;
      flower oil in suppressing serum uric acid.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in serum uric acid from baseline</measure>
    <time_frame>Every 4 weeks (Overall 8 weeks)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in uric acid clearance from baseline</measure>
    <time_frame>Every 4 weeks (Overall 8 weeks)</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">21</enrollment>
  <condition>Hyperuricemia</condition>
  <arm_group>
    <arm_group_label>200 mg CFO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>200 mg of chrysanthemum flower oil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>300 mg CFO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>300 mg of chrysanthemum flower oil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>400 mg CFO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>400 mg of chrysanthemum flower oil</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>200 mg of chrysanthemum flower oil</intervention_name>
    <arm_group_label>200 mg CFO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>300 mg of chrysanthemum flower oil</intervention_name>
    <arm_group_label>300 mg CFO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>400 mg of chrysanthemum flower oil</intervention_name>
    <arm_group_label>400 mg CFO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Serum uric acid 6.8-8.9 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Taking anti-hyperuricemic drugs&#xD;
&#xD;
          -  History of gouty attack&#xD;
&#xD;
          -  Taking drugs or functional food that may affect serum uric acid level&#xD;
&#xD;
          -  Hypertention, hyperlipidemia, or diabetes millitus&#xD;
&#xD;
          -  Participation in any clinical trial within 90 days of the commencement of the trial&#xD;
&#xD;
          -  Renal or hepatic dysfunction&#xD;
&#xD;
          -  Heart disease&#xD;
&#xD;
          -  History of severe disease and/or major surgery&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fumiko Higashikawa, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hiroshima University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hiroshima University</name>
      <address>
        <city>Hiroshima</city>
        <zip>734-8551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <last_update_submitted>August 15, 2016</last_update_submitted>
  <last_update_submitted_qc>August 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hiroshima University</investigator_affiliation>
    <investigator_full_name>Fumiko Higashikawa</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperuricemia</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/NCT02213562
org study id: eki-997
nct id: NCT02213562
lead sponsor: 
collaborator: 
has dmc: No
The aim of this study is to investigate the efficacy and dose-dependency of chrysanthemum
      flower oil in suppressing serum uric acid.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in serum uric acid from baseline
time frame: Every 4 weeks (Overall 8 weeks)
measure: Change in uric acid clearance from baseline
time frame: Every 4 weeks (Overall 8 weeks)
arm group label: 200 mg CFO
arm group type: Experimental
description: 200 mg of chrysanthemum flower oil
arm group label: 300 mg CFO
arm group type: Experimental
description: 300 mg of chrysanthemum flower oil
arm group label: 400 mg CFO
arm group type: Experimental
description: 400 mg of chrysanthemum flower oil
intervention type: Dietary Supplement
intervention name: 200 mg of chrysanthemum flower oil
arm group label: 200 mg CFO
intervention type: Dietary Supplement
intervention name: 300 mg of chrysanthemum flower oil
arm group label: 300 mg CFO
intervention type: Dietary Supplement
intervention name: 400 mg of chrysanthemum flower oil
arm group label: 400 mg CFO
criteria: 
gender: Male
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fumiko Higashikawa, PhD
role: Principal Investigator
affiliation: Hiroshima University
facility: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Hiroshima University
investigator full name: Fumiko Higashikawa
investigator title: Associate Professor
mesh term: Hyperuricemia