<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/NCT03258242</url>
  </required_header>
  <id_info>
    <org_study_id>KH105-B02-CRP-2.0</org_study_id>
    <nct_id>NCT03258242</nct_id>
  </id_info>
  <brief_title>A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy</brief_title>
  <official_title>A Randomized, Double-masked, Multicenter, Placebo Controlled Study of Keluo Xin Capsule on Efficacy and Safety in Patients With Diabetic Retinopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chengdu Kanghong Pharmaceutical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chengdu Kanghong Pharmaceutical Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study aiming to assess the efficacy and safety of Keluo Xin capsule in patients&#xD;
      with moderately severe to severe nonproliferative diabetic retinopathy (NPDR). Two-thirds of&#xD;
      participates will receive Keluo Xin capsules while other one third will receive placebo.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study composes two parts. The first is a 24-week period during which subjects receive&#xD;
      designed treatment regimen; after that, subjects will be informed again for the next 24-week&#xD;
      regimen (extention phase) and can choose whether or not to participate in the treatment (with&#xD;
      the same regimen in the first period) voluntarily.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 31, 2017</start_date>
  <completion_date type="Anticipated">February 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2019</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 change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks</measure>
    <time_frame>Baseline and 48 weeks</time_frame>
    <description>Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .</measure>
    <time_frame>Baseline and 48 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).</measure>
    <time_frame>Baseline and 48 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from baseline in Chinese medicine syndrome score chart at 24 weeks</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>The score chart is based on the typical symptoms and signs both in the eye and whole body on patients with DR and is used to assess DR severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from baseline in Chinese medicine syndrome score chart at 48 weeks</measure>
    <time_frame>Baseline and 48 weeks</time_frame>
    <description>The score chart is based on the typical symptoms and signs both in the eye and whole body on patients with DR and is used to assess DR severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in best corrected visual acuity at 24 weeks</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean change from baseline in best corrected visual acuity at 48 weeks</measure>
    <time_frame>Baseline and 48 weeks</time_frame>
    <description>Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency and severity of ocular and non-ocular adverse events over time</measure>
    <time_frame>Screening to 24 weeks and 48 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change of retinal blood flow density</measure>
    <time_frame>Baseline and 24 weeks</time_frame>
    <description>A exploratory objective which will be evaluated by angio OCT.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change of retinal blood flow density</measure>
    <time_frame>Baseline and 48 weeks</time_frame>
    <description>A exploratory objective which will be evaluated by angio OCT.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">198</enrollment>
  <condition>Moderately Severe to Severe NPDR</condition>
  <arm_group>
    <arm_group_label>Experimental: Keluo Xin Capsule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Comparator: Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Keluo Xin capsule</intervention_name>
    <description>four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.</description>
    <arm_group_label>Experimental: Keluo Xin Capsule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo oral capsule</intervention_name>
    <description>four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.</description>
    <arm_group_label>Placebo Comparator: Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years to 70 years;&#xD;
&#xD;
          -  Patients diagnosed with type 2 diabetes mellitus;&#xD;
&#xD;
          -  Patients diagnosed with nonproliferative diabetic retinopathy;&#xD;
&#xD;
          -  Patients diagnosed with traditional Chinese medicine syndrome(TCM) differentiation of&#xD;
             both Qi and Yin deficiency with blood Stasis;&#xD;
&#xD;
          -  HbA1c≤8.0%;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Study eye been received panretinal photocoagulation;&#xD;
&#xD;
          -  Study eye with neovascular elsewhere or neovascular of the disc, or neovascularization&#xD;
             of iris;&#xD;
&#xD;
          -  Prior panretinal photocoagulation in the study eye within 6 months;&#xD;
&#xD;
          -  Uncontrolled blood pressure;&#xD;
&#xD;
          -  Subjects who develop chronic diarrhoea;&#xD;
&#xD;
          -  Any history of acute diabetic complications;&#xD;
&#xD;
          -  Any history of allergy to components of Keluo Xin capsule;&#xD;
&#xD;
          -  Pregnant or breast-feeding women.&#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>Yanping Song, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wuhan General Hospital of Guangzhou Military, China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yanping Song, Professor</last_name>
    <phone>+86-27-50772574</phone>
    <email>songyanping@medmail.com.cn</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Quan Wu</last_name>
    <phone>+86-28-87516605</phone>
    <email>wuquan@cnkh.com</email>
  </overall_contact_backup>
  <reference>
    <citation>American Academy of Ophthalmology, &quot;Diabetic retinopathy.,&quot; 2014.</citation>
  </reference>
  <reference>
    <citation>Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.</citation>
    <PMID>24002281</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetic Retinopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03258242
org study id: KH105-B02-CRP-2.0
nct id: NCT03258242
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a study aiming to assess the efficacy and safety of Keluo Xin capsule in patients
      with moderately severe to severe nonproliferative diabetic retinopathy (NPDR). Two-thirds of
      participates will receive Keluo Xin capsules while other one third will receive placebo.
This study composes two parts. The first is a 24-week period during which subjects receive
      designed treatment regimen; after that, subjects will be informed again for the next 24-week
      regimen (extention phase) and can choose whether or not to participate in the treatment (with
      the same regimen in the first period) voluntarily.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks
time frame: Baseline and 24 weeks
description: Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
measure: Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks
time frame: Baseline and 48 weeks
description: Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
measure: Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
time frame: Baseline and 24 weeks
measure: Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .
time frame: Baseline and 48 weeks
measure: Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).
time frame: Baseline and 24 weeks
measure: Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).
time frame: Baseline and 48 weeks
measure: Mean change from baseline in Chinese medicine syndrome score chart at 24 weeks
time frame: Baseline and 24 weeks
description: The score chart is based on the typical symptoms and signs both in the eye and whole body on patients with DR and is used to assess DR severity.
measure: Mean change from baseline in Chinese medicine syndrome score chart at 48 weeks
time frame: Baseline and 48 weeks
description: The score chart is based on the typical symptoms and signs both in the eye and whole body on patients with DR and is used to assess DR severity.
measure: Mean change from baseline in best corrected visual acuity at 24 weeks
time frame: Baseline and 24 weeks
description: Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
measure: Mean change from baseline in best corrected visual acuity at 48 weeks
time frame: Baseline and 48 weeks
description: Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
measure: Frequency and severity of ocular and non-ocular adverse events over time
time frame: Screening to 24 weeks and 48 weeks
measure: Change of retinal blood flow density
time frame: Baseline and 24 weeks
description: A exploratory objective which will be evaluated by angio OCT.
measure: Change of retinal blood flow density
time frame: Baseline and 48 weeks
description: A exploratory objective which will be evaluated by angio OCT.
arm group label: Experimental: Keluo Xin Capsule
arm group type: Experimental
arm group label: Placebo Comparator: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Keluo Xin capsule
description: four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
arm group label: Experimental: Keluo Xin Capsule
intervention type: Drug
intervention name: Placebo oral capsule
description: four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
arm group label: Placebo Comparator: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Yanping Song, Professor
role: Principal Investigator
affiliation: Wuhan General Hospital of Guangzhou Military, China
last name: Yanping Song, Professor
phone: +86-27-50772574
email: songyanping@medmail.com.cn
last name: Quan Wu
phone: +86-28-87516605
email: wuquan@cnkh.com
citation: American Academy of Ophthalmology, "Diabetic retinopathy.," 2014.
citation: Xu Y, Wang L, He J, Bi Y, Li M, Wang T, Wang L, Jiang Y, Dai M, Lu J, Xu M, Li Y, Hu N, Li J, Mi S, Chen CS, Li G, Mu Y, Zhao J, Kong L, Chen J, Lai S, Wang W, Zhao W, Ning G; 2010 China Noncommunicable Disease Surveillance Group. Prevalence and control of diabetes in Chinese adults. JAMA. 2013 Sep 4;310(9):948-59. doi: 10.1001/jama.2013.168118.
PMID: 24002281
responsible party type: Sponsor
mesh term: Diabetic Retinopathy
sharing ipd: Undecided