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.