Status:
UNKNOWN
A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy
Lead Sponsor:
Chengdu Kanghong Pharmaceutical Co., Ltd.
Conditions:
Moderately Severe to Severe NPDR
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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...
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 (extenti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2020
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT03258242
Start Date
August 31 2017
End Date
February 28 2020
Last Update
August 24 2017
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