<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/NCT04448535</url>
  </required_header>
  <id_info>
    <org_study_id>1619383-1</org_study_id>
    <nct_id>NCT04448535</nct_id>
  </id_info>
  <brief_title>Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue</brief_title>
  <official_title>Effects of Ginkgo (Gingko Biloba) on Retinal and Choroidal Ocular Tissue</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York College of Optometry</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York College of Optometry</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 purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on&#xD;
      retinal and choroidal ocular tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study objectives are to:&#xD;
&#xD;
      1. assess the changes from pre- to post- oral supplementation on retinal and choroidal&#xD;
      thickness and blood flow, retinal oxygen saturation, ocular perfusion pressure, and retinal&#xD;
      function&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">August 3, 2022</completion_date>
  <primary_completion_date type="Actual">August 3, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ocular blood flow</measure>
    <time_frame>4 weeks</time_frame>
    <description>ocular blood flow measured with doppler ultrasound</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Gingko Biloba</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral intake of gingko biloba for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Gingko Biloba</intervention_name>
    <description>oral intake of Gingko Biloba, 240mg/day for 4 weeks</description>
    <arm_group_label>Gingko Biloba</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 20 - 55 years, inclusive&#xD;
&#xD;
          -  Good general and ocular health&#xD;
&#xD;
          -  Corrected visual acuity of 20/40 or better&#xD;
&#xD;
          -  No gingko biloba supplementation within the last 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All significant ocular and any systemic disorders considered likely to affect the&#xD;
             systemic or ocular vasculature&#xD;
&#xD;
          -  History of ocular surgery, including refractive surgery&#xD;
&#xD;
          -  Use of ocular medications&#xD;
&#xD;
          -  Conditions where ginkgo supplementation is contraindicated&#xD;
&#xD;
          -  Any eye or systemic disease that affect vision or refractive error&#xD;
&#xD;
          -  Current smokers&#xD;
&#xD;
          -  Subjects who are pregnant, breastfeeding, or planning conception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SUNY College of Optometry</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>October 20, 2022</last_update_submitted>
  <last_update_submitted_qc>October 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State University of New York College of Optometry</investigator_affiliation>
    <investigator_full_name>Alexandra Benavente</investigator_full_name>
    <investigator_title>Associate Clinical Professor</investigator_title>
  </responsible_party>
  <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/NCT04448535
org study id: 1619383-1
nct id: NCT04448535
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to understand the effect of Ginkgo Biloba oral supplements on
      retinal and choroidal ocular tissue.
The study objectives are to:

      1. assess the changes from pre- to post- oral supplementation on retinal and choroidal
      thickness and blood flow, retinal oxygen saturation, ocular perfusion pressure, and retinal
      function
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: ocular blood flow
time frame: 4 weeks
description: ocular blood flow measured with doppler ultrasound
arm group label: Gingko Biloba
arm group type: Experimental
description: oral intake of gingko biloba for 4 weeks
intervention type: Dietary Supplement
intervention name: Gingko Biloba
description: oral intake of Gingko Biloba, 240mg/day for 4 weeks
arm group label: Gingko Biloba
criteria: 
gender: All
minimum age: 20 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: State University of New York College of Optometry
investigator full name: Alexandra Benavente
investigator title: Associate Clinical Professor
sharing ipd: No