1. Title: A Study on TCM comprehensive protocol of Prevention and Control in Diabetic Retinopathy. 2. Objectives of study: To evaluate the Intervention effect of integrate control protocol on reducing the incidence rate of proliferative diabetic retinopathy, PRP and MVL. Then produce a high performance, optimize, convenient, applicable and demonstrated protocol of integrate control with Intervention of TCM and west medicine. 3. Study Type: Interventional 4. Study Design: Multi-center, Randomized, Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Positive controlled clinical study. 5. Sample size: 480 subjects , divided into test and control groups equally. 6. Primary endpoint: incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
1. Primary outcome: * proliferative diabetic retinopathy * panretinal photocoagulation 2. Secondary outcome: * Vision, Funduscopy, Fundus photograph * Fundus fluorescein angiography * Visual Electrophysiology:FERG、OPs、PVEP. * Optical coherence tomography. * Symptoms scores of TCM. * The M0S short-form-36 heaIth survey(SF-36). * Visual Function Questionnaire-25(VFQ-25).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
480
Qi ming granula Usage:4.5g,po,tid. duration:12 months/ arise Endpoint Event
Control group: Basic therapy & placebo 1. Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management , exercise and education. 2. placebo,Usage: 4.5g,po,tid
Chengdu University of TCM
Chengdu, Sichuan, China
incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation
Time frame: 12 months
Symptoms scores of TCM
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.