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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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ClinicalTrials.gov Identifier: NCT03258242
Recruitment Status : Not yet recruiting
First Posted : August 23, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Chengdu Kanghong Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Moderately Severe to Severe NPDR Drug: Keluo Xin capsule Drug: Placebo oral capsule Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-masked, Multicenter, Placebo Controlled Study of Keluo Xin Capsule on Efficacy and Safety in Patients With Diabetic Retinopathy
Estimated Study Start Date : August 31, 2017
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : February 28, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Experimental: Keluo Xin Capsule Drug: Keluo Xin capsule
four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
Placebo Comparator: Placebo Comparator: Placebo Drug: Placebo oral capsule
four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.



Primary Outcome Measures :
  1. Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.

  2. Mean change from DR severity as measured by the early treatment diabetic retinopathy score chart at 48 weeks [ Time Frame: Baseline and 48 weeks ]
    Based on the classification criteria of Early Treatment of Diabetic Retinopathy Study to grade DR severity.

  3. Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) . [ Time Frame: Baseline and 24 weeks ]
  4. Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) . [ Time Frame: Baseline and 48 weeks ]
  5. Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA). [ Time Frame: Baseline and 24 weeks ]
  6. Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA). [ Time Frame: Baseline and 48 weeks ]
  7. Mean change from baseline in Chinese medicine syndrome score chart at 24 weeks [ Time Frame: Baseline and 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.

  8. Mean change from baseline in Chinese medicine syndrome score chart at 48 weeks [ Time Frame: Baseline and 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 :
  1. Mean change from baseline in best corrected visual acuity at 24 weeks [ Time Frame: Baseline and 24 weeks ]
    Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

  2. Mean change from baseline in best corrected visual acuity at 48 weeks [ Time Frame: Baseline and 48 weeks ]
    Visual acuity is assessed by the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.

  3. Frequency and severity of ocular and non-ocular adverse events over time [ Time Frame: Screening to 24 weeks and 48 weeks ]

Other Outcome Measures:
  1. Change of retinal blood flow density [ Time Frame: Baseline and 24 weeks ]
    A exploratory objective which will be evaluated by angio OCT.

  2. Change of retinal blood flow density [ Time Frame: Baseline and 48 weeks ]
    A exploratory objective which will be evaluated by angio OCT.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03258242


Contacts
Contact: Yanping Song, Professor +86-27-50772574 songyanping@medmail.com.cn
Contact: Quan Wu +86-28-87516605 wuquan@cnkh.com

Sponsors and Collaborators
Chengdu Kanghong Pharmaceutical Co., Ltd.
Investigators
Principal Investigator: Yanping Song, Professor Wuhan General Hospital of Guangzhou Military, China

Publications:
Responsible Party: Chengdu Kanghong Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT03258242     History of Changes
Other Study ID Numbers: KH105-B02-CRP-2.0
First Posted: August 23, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases