<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/NCT02244996</url>
  </required_header>
  <id_info>
    <org_study_id>01121876</org_study_id>
    <nct_id>NCT02244996</nct_id>
  </id_info>
  <brief_title>Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum</brief_title>
  <official_title>Cone Rescue in Retinitis Pigmentosa by the Treatment of Lycium Barbarum</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hong Kong Polytechnic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The Hong Kong Polytechnic University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB)&#xD;
      treatment on retinal functions, especially the cone function, and retinal structure in&#xD;
      patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial&#xD;
&#xD;
      Setting: Primary Care clinical trial&#xD;
&#xD;
      Participants: 120 RP subjects will be recruited from Ophthalmology department at The&#xD;
      University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly&#xD;
      allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1&#xD;
      year. After the 1st year, both groups will stop the treatment and all subjects will also have&#xD;
      the same eye exam in 6-month period for the 2nd year.&#xD;
&#xD;
      Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 &amp; 60-4&#xD;
      programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave&#xD;
      amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct&#xD;
      component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS visual&#xD;
      acuity.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was a randomized controlled trial with a double-masked, placebo-controlled design.&#xD;
      All the subjects were randomly allocated into either LB (treatment) group or placebo&#xD;
      (control) group.&#xD;
&#xD;
      All the eligible subjects had the eye examination, including VA using the Early Treatment of&#xD;
      Diabetic Retinopathy Study (ETDRS) chart, refractions, tonometry, external and internal&#xD;
      ocular health assessments, and fundus photo-documentation. Three additional tests were&#xD;
      conducted to investigate the functional and structural changes in the RP patients, including&#xD;
      Ganzfeld Electroretinogram, Humphrey Visual Field Analyser (Zeiss, Dublin, USA) and&#xD;
      Spectral-domain Optical Coherent Tomography (SD-OCT) (Heidelberg Engineering, USA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">April 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>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ETDRS Visual Acuity (High Contrast)</measure>
    <time_frame>12 months</time_frame>
    <description>The high contrast visual acuity will be measured at the time point of baseline and 12 months. Visual acuity is to measure the eye's ability to resolve fine detail with full refractive error correction.&#xD;
The change of acuity (sec of arc) between 12-month time point and baseline will be provided to show the effect of interventions.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Field Sensitivity</measure>
    <time_frame>12 months</time_frame>
    <description>Humphrey Visual Field Analyser will be used to measure the brightness sensitivity across the central 30 degree visual field at time point of baseline and 12 months. Visual field is to measure the size of the field of view and the sensitivity of the corresponding locations of the field of view.&#xD;
The change of sensitivity (dB) between 12-month time point and baseline will be provide to show the effects of interventions.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amplitudes of Flash Electroretinogram</measure>
    <time_frame>12 months</time_frame>
    <description>The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation.&#xD;
The change of cone response b-wave amplitude (uV) between 12-month and baseline will be provided to show the effect of interventions. The b-wave amplitude is to measure the magnitude of electrical responses of cone cells in the retina.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Implicit Times of Flash Electroretinogram</measure>
    <time_frame>12 months</time_frame>
    <description>The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation.&#xD;
The change of cone response b-wave implicit time (ms) between 12-month and baseline will be provided to show the effect of interventions. The b-wave implicit time is to measure the physiological changes of cone cells in the retina.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Retinitis Pigmentosa</condition>
  <arm_group>
    <arm_group_label>Lycium Barbarum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Daily Lycium Barbarum dosage: 10g of granules for 12 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Lycium Barbarum</intervention_name>
    <description>Traditional Chinese Herbs</description>
    <arm_group_label>Lycium Barbarum</arm_group_label>
    <other_name>Wolfberry</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Ocular conditions:&#xD;
&#xD;
          -  Retinitis pigmentosa;&#xD;
&#xD;
          -  best corrected VA LogMAR 0.20 or better;&#xD;
&#xD;
          -  Humphrey Visual Field Analysis (HVFA) 30-2 total mean defect &gt; or = 250 Decibel;&#xD;
&#xD;
          -  Intra-ocular pressure (IOP) &lt;21 mmHg;&#xD;
&#xD;
          -  van Herrick ratio &lt; or = 0.5;&#xD;
&#xD;
          -  no other ocular diseases&#xD;
&#xD;
        Dietary conditions:&#xD;
&#xD;
          -  Fruit and vegetable intake &lt;10 servings/day;&#xD;
&#xD;
          -  spinach or kale intake &lt; or = serving/day;&#xD;
&#xD;
          -  dietary lutein intake &lt; or = 5.4mg/day;&#xD;
&#xD;
          -  no intake of cod liver oil or omega-3 capsules;&#xD;
&#xD;
          -  dietary Lycium barbarum intake &lt; or =10 fruits/week;&#xD;
&#xD;
          -  supplement intake &lt; or = 5000 IU/day of Vit. A and &lt; or = 30 IU/day of Vit. E;&#xD;
&#xD;
          -  alcoholic consumption &lt; or = 3 beverages/day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 40;&#xD;
&#xD;
          -  intake of any anticoagulants (especially Warfarin),&#xD;
&#xD;
          -  pregnant or planning to be pregnant;&#xD;
&#xD;
          -  smoking;&#xD;
&#xD;
          -  other clinically significant systemic diseases, eg. diabetes, liver disease and heart&#xD;
             disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henry HL Chan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Hong Kong Polytechnic University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Hong Kong Polytechnic University</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 17, 2014</study_first_submitted>
  <study_first_submitted_qc>September 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <results_first_submitted>November 27, 2017</results_first_submitted>
  <results_first_submitted_qc>August 14, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 28, 2019</results_first_posted>
  <last_update_submitted>January 28, 2019</last_update_submitted>
  <last_update_submitted_qc>January 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hong Kong Polytechnic University</investigator_affiliation>
    <investigator_full_name>Henry HL Chan, PhD</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Retinitis pigmentosa</keyword>
  <keyword>Lycium barbarum</keyword>
  <keyword>Antioxidation</keyword>
  <keyword>Visual field</keyword>
  <keyword>Electroretinogram</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Retinitis</mesh_term>
    <mesh_term>Retinitis Pigmentosa</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruited from a retinal disease patient association, Retina Hong Kong, and the Optometry Clinic at The Hong Kong Polytechnic University</recruitment_details>
      <pre_assignment_details>All the eligible subjects had the eye examination, including VA (ETDRS) charts, refractions, tonometry, external and internal ocular health assessments, fundus photo-documentation, Ganzfeld Electroretinogram, Humphrey Visual Field Analyser and Spectral-domain Optical Coherent Tomography</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Lycium Barbarum</title>
          <description>Daily Lycium Barbarum dosage: 10g of granules for 12 months&#xD;
Lycium Barbarum: Traditional Chinese Herbs</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo: Placebo</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="25"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Lycium Barbarum</title>
          <description>Daily Lycium Barbarum dosage: 10g of granules for 12 months&#xD;
Lycium Barbarum: Traditional Chinese Herbs</description>
        </group>
        <group group_id="B2">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo: Placebo</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="23"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="42"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="50.4" spread="12.2"/>
                    <measurement group_id="B2" value="48.4" spread="9.3"/>
                    <measurement group_id="B3" value="49.4" 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="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </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>Hong Kong</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>ETDRS Visual Acuity (High Contrast)</title>
        <description>The high contrast visual acuity will be measured at the time point of baseline and 12 months. Visual acuity is to measure the eye's ability to resolve fine detail with full refractive error correction.&#xD;
The change of acuity (sec of arc) between 12-month time point and baseline will be provided to show the effect of interventions.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lycium Barbarum</title>
            <description>Daily Lycium Barbarum dosage: 10g of granules for 12 months&#xD;
Lycium Barbarum: Traditional Chinese Herbs</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>ETDRS Visual Acuity (High Contrast)</title>
          <description>The high contrast visual acuity will be measured at the time point of baseline and 12 months. Visual acuity is to measure the eye's ability to resolve fine detail with full refractive error correction.&#xD;
The change of acuity (sec of arc) between 12-month time point and baseline will be provided to show the effect of interventions.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.</description>
          <units>log unit</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.02" spread="0.09"/>
                    <measurement group_id="O2" value="0.11" spread="0.17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Field Sensitivity</title>
        <description>Humphrey Visual Field Analyser will be used to measure the brightness sensitivity across the central 30 degree visual field at time point of baseline and 12 months. Visual field is to measure the size of the field of view and the sensitivity of the corresponding locations of the field of view.&#xD;
The change of sensitivity (dB) between 12-month time point and baseline will be provide to show the effects of interventions.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lycium Barbarum</title>
            <description>Daily Lycium Barbarum dosage: 10g of granules for 12 months&#xD;
Lycium Barbarum: Traditional Chinese Herbs</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Field Sensitivity</title>
          <description>Humphrey Visual Field Analyser will be used to measure the brightness sensitivity across the central 30 degree visual field at time point of baseline and 12 months. Visual field is to measure the size of the field of view and the sensitivity of the corresponding locations of the field of view.&#xD;
The change of sensitivity (dB) between 12-month time point and baseline will be provide to show the effects of interventions.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum</description>
          <units>dB</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.32" spread="2.93"/>
                    <measurement group_id="O2" value="-0.16" spread="0.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Amplitudes of Flash Electroretinogram</title>
        <description>The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation.&#xD;
The change of cone response b-wave amplitude (uV) between 12-month and baseline will be provided to show the effect of interventions. The b-wave amplitude is to measure the magnitude of electrical responses of cone cells in the retina.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lycium Barbarum</title>
            <description>Daily Lycium Barbarum dosage: 10g of granules for 12 months&#xD;
Lycium Barbarum: Traditional Chinese Herbs</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Amplitudes of Flash Electroretinogram</title>
          <description>The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation.&#xD;
The change of cone response b-wave amplitude (uV) between 12-month and baseline will be provided to show the effect of interventions. The b-wave amplitude is to measure the magnitude of electrical responses of cone cells in the retina.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.</description>
          <units>uV</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.75" spread="9.17"/>
                    <measurement group_id="O2" value="-4.00" spread="7.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Implicit Times of Flash Electroretinogram</title>
        <description>The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation.&#xD;
The change of cone response b-wave implicit time (ms) between 12-month and baseline will be provided to show the effect of interventions. The b-wave implicit time is to measure the physiological changes of cone cells in the retina.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.</description>
        <time_frame>12 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Lycium Barbarum</title>
            <description>Daily Lycium Barbarum dosage: 10g of granules for 12 months&#xD;
Lycium Barbarum: Traditional Chinese Herbs</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Placebo&#xD;
Placebo: Placebo</description>
          </group>
        </group_list>
        <measure>
          <title>Implicit Times of Flash Electroretinogram</title>
          <description>The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation.&#xD;
The change of cone response b-wave implicit time (ms) between 12-month and baseline will be provided to show the effect of interventions. The b-wave implicit time is to measure the physiological changes of cone cells in the retina.&#xD;
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.</description>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="23"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.33" spread="5.03"/>
                    <measurement group_id="O2" value="-1" spread="6.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>12 months</time_frame>
      <desc>Self reporting</desc>
      <group_list>
        <group group_id="E1">
          <title>Lycium Barbarum</title>
          <description>Daily Lycium Barbarum dosage: 10g of granules for 12 months&#xD;
Lycium Barbarum: Traditional Chinese Herbs</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Placebo&#xD;
Placebo: Placebo</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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. Henry Chan</name_or_title>
      <organization>Hong Kong Polytechnic University</organization>
      <phone>85227667937</phone>
      <email>henryhl.chan@polyu.edu.hk</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/NCT02244996
org study id: 01121876
nct id: NCT02244996
lead sponsor: 
collaborator: 
has dmc: No
Objectives: To study the immediate effect and the persistent effect of Lycium barbarum (LB)
      treatment on retinal functions, especially the cone function, and retinal structure in
      patients with retinitis pigmentosa (RP) Design: Randomised controlled double-masked trial

      Setting: Primary Care clinical trial

      Participants: 120 RP subjects will be recruited from Ophthalmology department at The
      University of Hong Kong and the Retina Hong Kong. Interventions: Subjects will be randomly
      allocated to LB (treated with LB granules) or control (treated with placebo) groups for 1
      year. After the 1st year, both groups will stop the treatment and all subjects will also have
      the same eye exam in 6-month period for the 2nd year.

      Main outcome measures: The primary outcome is the total sensitivity scores of 30-2 & 60-4
      programmes of Humphrey Visual Field Analysis (HVFA). The secondary outcomes are the b-wave
      amplitudes of Full-field Electroretinogram (ffERG) responses, the amplitudes of direct
      component and induced component of Multifocal Electroretinogram (mfERG), and the ETDRS visual
      acuity.
The study was a randomized controlled trial with a double-masked, placebo-controlled design.
      All the subjects were randomly allocated into either LB (treatment) group or placebo
      (control) group.

      All the eligible subjects had the eye examination, including VA using the Early Treatment of
      Diabetic Retinopathy Study (ETDRS) chart, refractions, tonometry, external and internal
      ocular health assessments, and fundus photo-documentation. Three additional tests were
      conducted to investigate the functional and structural changes in the RP patients, including
      Ganzfeld Electroretinogram, Humphrey Visual Field Analyser (Zeiss, Dublin, USA) and
      Spectral-domain Optical Coherent Tomography (SD-OCT) (Heidelberg Engineering, USA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: ETDRS Visual Acuity (High Contrast)
time frame: 12 months
description: The high contrast visual acuity will be measured at the time point of baseline and 12 months. Visual acuity is to measure the eye's ability to resolve fine detail with full refractive error correction.
The change of acuity (sec of arc) between 12-month time point and baseline will be provided to show the effect of interventions.
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.
measure: Visual Field Sensitivity
time frame: 12 months
description: Humphrey Visual Field Analyser will be used to measure the brightness sensitivity across the central 30 degree visual field at time point of baseline and 12 months. Visual field is to measure the size of the field of view and the sensitivity of the corresponding locations of the field of view.
The change of sensitivity (dB) between 12-month time point and baseline will be provide to show the effects of interventions.
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum
measure: Amplitudes of Flash Electroretinogram
time frame: 12 months
description: The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation.
The change of cone response b-wave amplitude (uV) between 12-month and baseline will be provided to show the effect of interventions. The b-wave amplitude is to measure the magnitude of electrical responses of cone cells in the retina.
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.
measure: Implicit Times of Flash Electroretinogram
time frame: 12 months
description: The cone responses from electroretinogram will be measured at the time point of baseline and 12 months. The cone response is related to the activity of the cone photoreceptor under light stimulation.
The change of cone response b-wave implicit time (ms) between 12-month and baseline will be provided to show the effect of interventions. The b-wave implicit time is to measure the physiological changes of cone cells in the retina.
The changes of the treatment group will be compared with the changes of the placebo group to illustrate the treatment effect of Lycium Barbarum.
arm group label: Lycium Barbarum
arm group type: Experimental
description: Daily Lycium Barbarum dosage: 10g of granules for 12 months
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo
intervention type: Dietary Supplement
intervention name: Lycium Barbarum
description: Traditional Chinese Herbs
arm group label: Lycium Barbarum
other name: Wolfberry
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Henry HL Chan, PhD
role: Principal Investigator
affiliation: The Hong Kong Polytechnic University
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The Hong Kong Polytechnic University
investigator full name: Henry HL Chan, PhD
investigator title: Associate Professor
mesh term: Retinitis
mesh term: Retinitis Pigmentosa
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 