NCT00904592

A Study on Traditional Chinese Medicine (TCM) Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy

A Study on TCM Comprehensive Protocol of Prevention and Control in Diabetic Retinopathy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: Chengdu University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Diabetic Retinopathy

Interventions

Type	Name	Description
DRUG	Qi ming granula	Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event
DRUG	Placebo Comparator	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

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-10-01
• Completion: 2011-04-01
• First posted: 2009-05-19
• Last updated: 2012-08-21

Locations

1 site across 1 country: China