<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/NCT02976766</url>
  </required_header>
  <id_info>
    <org_study_id>GXON-001</org_study_id>
    <nct_id>NCT02976766</nct_id>
  </id_info>
  <brief_title>Gypenosides Treatment for Optic Neuritis</brief_title>
  <official_title>Gypenosides Treatment for Optic Neuritis: a Randomised, Double-blind, Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Affiliated Hospital of Guangxi Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital of Guangxi Medical University</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 determine whether gypenosides are neuroprotective in patients&#xD;
      with acute optic neuritis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Low enrolment&#xD;
  </why_stopped>
  <start_date type="Actual">February 4, 2017</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean retinal nerve fibre layer thickness</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total macular volume</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Best corrected visual acuity</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Latency and amplitude of visual evoked potentials</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean visual field defect</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Adverse events</measure>
    <time_frame>Screening until end of study</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Optic Neuritis</condition>
  <arm_group>
    <arm_group_label>Gypenosides</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>Drug</intervention_type>
    <intervention_name>Gypenosides</intervention_name>
    <description>Participants will receive gypenosides 360 mg/day (120 mg three times a day) for 10 days.</description>
    <arm_group_label>Gypenosides</arm_group_label>
    <other_name>Jiaogulan Zongdai</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants will receive placebo three times a day for 10 days.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          1. Male and female Chinese patients aged ≥18 to ≤60 years&#xD;
&#xD;
          2. Patients with a first episode of optic neuritis in the eye of interest&#xD;
&#xD;
          3. First symptoms of optic neuritis ≤28 days prior to the first administration of&#xD;
             investigational product&#xD;
&#xD;
          4. Best corrected visual acuity in the eye of interest ≤0.8&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          1. Pre-existing multiple sclerosis MS or NMO&#xD;
&#xD;
          2. Refractive media opacity&#xD;
&#xD;
          3. Hyperopia &gt;5 diopters, myopia &lt;-5 diopters, or astigmatism &gt;3 diopters&#xD;
&#xD;
          4. Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension,&#xD;
             diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially&#xD;
             interfering treatment trial&#xD;
&#xD;
          5. Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)&#xD;
&#xD;
          6. Existing other retina or optic nerve diseases&#xD;
&#xD;
          7. Pregnant or females who plan to be pregnant during study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yi Du, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Guangxi Medical University, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangxi Medical University</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530021</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 25, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>April 7, 2021</last_update_submitted>
  <last_update_submitted_qc>April 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital of Guangxi Medical University</investigator_affiliation>
    <investigator_full_name>Yi Du</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Neuroprotection</keyword>
  <keyword>Clinical trial</keyword>
  <keyword>Traditional Chinese medicine</keyword>
  <keyword>Axonal loss</keyword>
  <keyword>Jiaogulan</keyword>
  <keyword>Gynostemma pentaphyllum</keyword>
  <keyword>Optical coherence tomography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuritis</mesh_term>
    <mesh_term>Optic Neuritis</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/NCT02976766
org study id: GXON-001
nct id: NCT02976766
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine whether gypenosides are neuroprotective in patients
      with acute optic neuritis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean retinal nerve fibre layer thickness
time frame: 6 months
measure: Total macular volume
time frame: 6 months
measure: Best corrected visual acuity
time frame: 6 months
measure: Latency and amplitude of visual evoked potentials
time frame: 6 months
measure: Mean visual field defect
time frame: 6 months
measure: Number of participants with Adverse events
time frame: Screening until end of study
arm group label: Gypenosides
arm group type: Experimental
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Gypenosides
description: Participants will receive gypenosides 360 mg/day (120 mg three times a day) for 10 days.
arm group label: Gypenosides
other name: Jiaogulan Zongdai
intervention type: Drug
intervention name: Placebo
description: Participants will receive placebo three times a day for 10 days.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Yi Du, MD
role: Principal Investigator
affiliation: The First Affiliated Hospital of Guangxi Medical University, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: First Affiliated Hospital of Guangxi Medical University
investigator full name: Yi Du
investigator title: Dr.
mesh term: Neuritis
mesh term: Optic Neuritis