A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy
A Randomized, Double-masked, Multicenter, Placebo Controlled Study of Keluo Xin Capsule on Efficacy and Safety in Patients With Diabetic Retinopathy
1 other identifier
interventional
198
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Aug 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2017
CompletedFirst Posted
Study publicly available on registry
August 23, 2017
CompletedStudy Start
First participant enrolled
August 31, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedAugust 24, 2017
August 1, 2017
2 years
August 4, 2017
August 22, 2017
Conditions
Outcome Measures
Primary Outcomes (8)
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.
Baseline and 24 weeks
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.
Baseline and 48 weeks
Pathological changes from baseline at 24 weeks as measured by optical coherence tomography (OCT) .
Baseline and 24 weeks
Pathological changes from baseline at 48 weeks as measured by optical coherence tomography (OCT) .
Baseline and 48 weeks
Pathological changes from baseline at 24 weeks as measured by fluorescence angiography (FFA).
Baseline and 24 weeks
Pathological changes from baseline at 48 weeks as measured by fluorescence angiography (FFA).
Baseline and 48 weeks
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.
Baseline and 24 weeks
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.
Baseline and 48 weeks
Secondary Outcomes (3)
Mean change from baseline in best corrected visual acuity at 24 weeks
Baseline and 24 weeks
Mean change from baseline in best corrected visual acuity at 48 weeks
Baseline and 48 weeks
Frequency and severity of ocular and non-ocular adverse events over time
Screening to 24 weeks and 48 weeks
Other Outcomes (2)
Change of retinal blood flow density
Baseline and 24 weeks
Change of retinal blood flow density
Baseline and 48 weeks
Study Arms (2)
Experimental: Keluo Xin Capsule
EXPERIMENTALPlacebo Comparator: Placebo
PLACEBO COMPARATORInterventions
four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
Eligibility Criteria
You may qualify if:
- 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%;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
American Academy of Ophthalmology, "Diabetic retinopathy.," 2014.
BACKGROUNDXu 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: 24002281BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
Yanping Song, Professor
Wuhan General Hospital of Guangzhou Military, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2017
First Posted
August 23, 2017
Study Start
August 31, 2017
Primary Completion
August 31, 2019
Study Completion
February 28, 2020
Last Updated
August 24, 2017
Record last verified: 2017-08