<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/NCT03773315</url>
  </required_header>
  <id_info>
    <org_study_id>02-2018-029</org_study_id>
    <nct_id>NCT03773315</nct_id>
  </id_info>
  <brief_title>Ulmus Macrocarpa Hance Extract and Lipid Profile</brief_title>
  <official_title>Effect of Ulmus Macrocarpa Hance Extract on Lipid Profile in Adults With Dyslipidemia: a RCT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sang Yeoup Lee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pusan National University Yangsan Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators conduct a randomized, double-blind, placebo-controlled study to investigate&#xD;
      the effects of the Ulmus Macrocarpa Hance extract on lipid profile in adults with&#xD;
      dyslipidemia for 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Previous another our study have indicated that Ulmus Macrocarpa Hance extract (UMH) may have&#xD;
      the ability to decrease blood cholesterol. Therefore, the investigators conduct a randomized,&#xD;
      double-blind, placebo-controlled study to investigate the effects of the UMH on lipid profile&#xD;
      in adults with dyslipidemia; the safety of the compound are also evaluate. The Investigators&#xD;
      examine total cholesterol, HDL-cholesterol, triglyceridemia, LDL-cholesterol, and other&#xD;
      biochemical parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty&#xD;
      adults were administered either 500 mg of UMH or a placebo each day for 12 weeks;&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 14, 2020</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>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>LDL cholesterol</measure>
    <time_frame>12 weeks</time_frame>
    <description>LDL cholesterol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total cholesterol</measure>
    <time_frame>12 weeks</time_frame>
    <description>Total cholesterol</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Triglyceride</measure>
    <time_frame>12 weeks</time_frame>
    <description>Triglyceride</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HDL cholesterol</measure>
    <time_frame>12 weeks</time_frame>
    <description>HDL cholesterol</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Dyslipidemias</condition>
  <arm_group>
    <arm_group_label>UMH group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group takes UMH extract for 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>This group takes placebo for 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>UMH extract</intervention_name>
    <description>Schisandra chinensis extract 500 mg/day for 12 weeks</description>
    <arm_group_label>UMH group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Starch placebo 500 mg/day for 12 weeks</description>
    <arm_group_label>Placebo group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  LDL cholesterol ranging from 130 to 190 mg/dL&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal liver or renal function (i.e., serum aminotransferase activity &gt; 80 IU/L and&#xD;
             serum creatinine concentrations &gt; 1.2 mg/dL)&#xD;
&#xD;
          -  Diabetes (diagnosed clinically or fasting glucose level &gt; 126 mg/dL)&#xD;
&#xD;
          -  History of ischemic heart disease or cerebrovascular disease&#xD;
&#xD;
          -  Uncontrolled hypertension&#xD;
&#xD;
          -  History of serious cardiac disease such as angina or myocardial infarction&#xD;
&#xD;
          -  History of gastrectomy&#xD;
&#xD;
          -  History of medication for psychiatric disease&#xD;
&#xD;
          -  Administration of oriental medicine including herbs within the past 4 weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang Yeoup Lee</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pusan National University Yangsan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Integrated Research Institute for Natural Ingredients and Functional Foods</name>
      <address>
        <city>Yangsan</city>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>April 27, 2021</last_update_submitted>
  <last_update_submitted_qc>April 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Pusan National University Yangsan Hospital</investigator_affiliation>
    <investigator_full_name>Sang Yeoup Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslipidemias</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/NCT03773315
org study id: 02-2018-029
nct id: NCT03773315
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators conduct a randomized, double-blind, placebo-controlled study to investigate
      the effects of the Ulmus Macrocarpa Hance extract on lipid profile in adults with
      dyslipidemia for 12 weeks.
Previous another our study have indicated that Ulmus Macrocarpa Hance extract (UMH) may have
      the ability to decrease blood cholesterol. Therefore, the investigators conduct a randomized,
      double-blind, placebo-controlled study to investigate the effects of the UMH on lipid profile
      in adults with dyslipidemia; the safety of the compound are also evaluate. The Investigators
      examine total cholesterol, HDL-cholesterol, triglyceridemia, LDL-cholesterol, and other
      biochemical parameters at baseline, as well as after 6 and 12 weeks of intervention. Eighty
      adults were administered either 500 mg of UMH or a placebo each day for 12 weeks;
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: LDL cholesterol
time frame: 12 weeks
description: LDL cholesterol
measure: Total cholesterol
time frame: 12 weeks
description: Total cholesterol
measure: Triglyceride
time frame: 12 weeks
description: Triglyceride
measure: HDL cholesterol
time frame: 12 weeks
description: HDL cholesterol
arm group label: UMH group
arm group type: Experimental
description: This group takes UMH extract for 12 weeks
arm group label: Placebo group
arm group type: Placebo Comparator
description: This group takes placebo for 12 weeks
intervention type: Dietary Supplement
intervention name: UMH extract
description: Schisandra chinensis extract 500 mg/day for 12 weeks
arm group label: UMH group
intervention type: Dietary Supplement
intervention name: Placebo
description: Starch placebo 500 mg/day for 12 weeks
arm group label: Placebo group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sang Yeoup Lee
role: Principal Investigator
affiliation: Pusan National University Yangsan Hospital
facility: 
country: Korea, Republic of
responsible party type: Sponsor-Investigator
investigator affiliation: Pusan National University Yangsan Hospital
investigator full name: Sang Yeoup Lee
investigator title: Professor
mesh term: Dyslipidemias