Overview
A Study of Keluo Xin Capsule Compare to Placebo in Terms of Efficacy and Safety in Patients With Diabetic Retinopathy
Status:
Unknown status
Unknown status
Trial end date:
2020-02-28
2020-02-28
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Chengdu Kanghong Pharmaceutical Co., Ltd.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.