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

Kanghong Pharmaceutical

Status and phase

Unknown

Phase 2

Conditions

Moderately Severe to Severe NPDR

Treatments

Drug: Keluo Xin capsule

Drug: Placebo oral capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT03258242

KH105-B02-CRP-2.0

Details and patient eligibility

About

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.

Full 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 (extention phase) and can choose whether or not to participate in the treatment (with the same regimen in the first period) voluntarily.

Enrollment

198 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.