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A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy

Primary Purpose

Moderately Severe to Severe NPDR

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Keluo Xin capsule
Placebo oral capsule
Sponsored by
Chengdu Kanghong Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Moderately Severe to Severe NPDR

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years to 70 years;
  • Patients diagnosed with type 2 diabetes mellitus;
  • Patients diagnosed with nonproliferative diabetic retinopathy;
  • Patients diagnosed with traditional Chinese medicine syndrome(TCM) differentiation of both Qi and Yin deficiency with blood Stasis;
  • HbA1c≤8.0%;

Exclusion Criteria:

  • Study eye been received panretinal photocoagulation;
  • Study eye with neovascular elsewhere or neovascular of the disc, or neovascularization of iris;
  • Prior panretinal photocoagulation in the study eye within 6 months;
  • Uncontrolled blood pressure;
  • Subjects who develop chronic diarrhoea;
  • Any history of acute diabetic complications;
  • Any history of allergy to components of Keluo Xin capsule;
  • Pregnant or breast-feeding women.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental: Keluo Xin Capsule

    Placebo Comparator: Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks
    Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
    Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks
    Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
    Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
    Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .
    Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).
    Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).
    Mean change from baseline in Chinese medicine syndrome score chart at 24 weeks
    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.
    Mean change from baseline in Chinese medicine syndrome score chart at 48 weeks
    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.

    Secondary Outcome Measures

    Mean change from baseline in best corrected visual acuity at 24 weeks
    Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
    Mean change from baseline in best corrected visual acuity at 48 weeks
    Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
    Frequency and severity of ocular and non-ocular adverse events over time

    Full Information

    First Posted
    August 4, 2017
    Last Updated
    August 22, 2017
    Sponsor
    Chengdu Kanghong Pharmaceutical Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03258242
    Brief Title
    A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy
    Official Title
    A Randomized, Double-masked, Multicenter, Placebo Controlled Study of Keluo Xin Capsule on Efficacy and Safety in Patients With Diabetic Retinopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 31, 2017 (Anticipated)
    Primary Completion Date
    August 31, 2019 (Anticipated)
    Study Completion Date
    February 28, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Chengdu Kanghong Pharmaceutical Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Moderately Severe to Severe NPDR

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    198 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental: Keluo Xin Capsule
    Arm Type
    Experimental
    Arm Title
    Placebo Comparator: Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Keluo Xin capsule
    Intervention Description
    four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral capsule
    Intervention Description
    four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
    Primary Outcome Measure Information:
    Title
    Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks
    Description
    Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
    Time Frame
    Baseline and 24 weeks
    Title
    Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks
    Description
    Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.
    Time Frame
    Baseline and 48 weeks
    Title
    Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
    Time Frame
    Baseline and 24 weeks
    Title
    Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .
    Time Frame
    Baseline and 48 weeks
    Title
    Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).
    Time Frame
    Baseline and 24 weeks
    Title
    Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).
    Time Frame
    Baseline and 48 weeks
    Title
    Mean change from baseline in Chinese medicine syndrome score chart at 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.
    Time Frame
    Baseline and 24 weeks
    Title
    Mean change from baseline in Chinese medicine syndrome score chart at 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.
    Time Frame
    Baseline and 48 weeks
    Secondary Outcome Measure Information:
    Title
    Mean change from baseline in best corrected visual acuity at 24 weeks
    Description
    Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
    Time Frame
    Baseline and 24 weeks
    Title
    Mean change from baseline in best corrected visual acuity at 48 weeks
    Description
    Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
    Time Frame
    Baseline and 48 weeks
    Title
    Frequency and severity of ocular and non-ocular adverse events over time
    Time Frame
    Screening to 24 weeks and 48 weeks
    Other Pre-specified Outcome Measures:
    Title
    Change of retinal blood flow density
    Description
    A exploratory objective which will be evaluated by angio OCT.
    Time Frame
    Baseline and 24 weeks
    Title
    Change of retinal blood flow density
    Description
    A exploratory objective which will be evaluated by angio OCT.
    Time Frame
    Baseline and 48 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 18 years to 70 years; Patients diagnosed with type 2 diabetes mellitus; Patients diagnosed with nonproliferative diabetic retinopathy; Patients diagnosed with traditional Chinese medicine syndrome(TCM) differentiation of both Qi and Yin deficiency with blood Stasis; HbA1c≤8.0%; Exclusion Criteria: Study eye been received panretinal photocoagulation; Study eye with neovascular elsewhere or neovascular of the disc, or neovascularization of iris; Prior panretinal photocoagulation in the study eye within 6 months; Uncontrolled blood pressure; Subjects who develop chronic diarrhoea; Any history of acute diabetic complications; Any history of allergy to components of Keluo Xin capsule; Pregnant or breast-feeding women.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yanping Song, Professor
    Phone
    +86-27-50772574
    Email
    songyanping@medmail.com.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Quan Wu
    Phone
    +86-28-87516605
    Email
    wuquan@cnkh.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yanping Song, Professor
    Organizational Affiliation
    Wuhan General Hospital of Guangzhou Military, China
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    Citation
    American Academy of Ophthalmology, "Diabetic retinopathy.," 2014.
    Results Reference
    background
    PubMed Identifier
    24002281
    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.
    Results Reference
    background

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    A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy

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