Overview

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

Status:
Unknown status
Trial end date:
2020-02-28
Target enrollment:
0
Participant gender:
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 2
Accepts Healthy Volunteers?
No
Details
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.