Efficacy and safety of qiming granule combined with laser in the treatment of diabetic retinopathy: A protocol of randomized controlled trial

BACKGROUND: Diabetic retinopathy is not only the most common complication of diabetes, but also 1 of the main causes of blindness, which seriously affects the physical and mental health of patients. Panretinal photocoagulation is a common method for the treatment of diabetic retinopathy, but it has some defects. Qiming granule has advantages in the treatment of diabetic retinopathy, but there is a lack of standard clinical research to verify it. Therefore, the purpose of this randomized controlled trial is to evaluate the efficacy and safety of qiming granule combined with laser in the treatment of diabetic retinopathy. METHODS: This is a prospective randomized controlled trial to study the efficacy and safety of Qiming granule combined with laser in the treatment of diabetic retinopathy. Approved by the Clinical Research Society of our hospital. The patients are randomly divided into a treatment group (Qiming granule combined with laser treatment group) or control group (simple laser treatment group). The patients are followed up for 12 months after 6 months of treatment. Observation indexes include total effective rate, corrected visual acuity, macular fovea thickness, adverse reactions and so on. Data are analyzed using the statistical software package SPSS version 18.0 (Chicago, IL). DISCUSSION: This study will evaluate the clinical efficacy and safety of qiming granule combined with laser in the treatment of diabetic retinopathy. The experimental results of this study will provide a reliable reference basis for clinical use of qiming granule combined with laser in the treatment of diabetic retinopathy. TRIAL REGISTRATION: OSF Registration number: DOI 10.17605/OSF.IO/ZEQPB.