Diabetic Retinopathy
Conditions
Keywords
diabetic retinopathy, traditional chinese medicine
Brief 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).
Interventions
DRUGQi ming granula
Qi ming granula Usage:4.5g，po，tid. duration:12 months/ arise Endpoint Event
DRUGPlacebo 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
Sponsors
Chengdu University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with diabetes mellitus. * Diagnosed with non-proliferative diabetic retinopathy, including moderate and severe diabetic retinopathy * and corrected VA≥45 letters(ETDRS), equivalent the decimal value of 0.16(20/125). * Diagnosed with the syndrome and signs of TCM. * HbA1C≤8.0%. * Ages ranged from 35 to 75 years. * Joined in the test voluntarily and signed the Informed consent by GCP regulation.
Exclusion criteria
* Complicating severe vitreous hemorrhage, or requiring laser and vitrectomy treatment. * The patients who have been received the therapy of Retina laser photocoagulation. * The patients whose dioptric media is so turbid that hard to evaluate the fundus picture. * DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month. * Combined with other severe Diabetic complication. * Having any allergic reaction to some drugs, food and pollen etc. or hypersensitiveness * Pregnant or breast feeding. * combined with primarily severe diseases such as cardiovascular, hepatic，renal illness ,hemopoietic system disease, and psychosis. * Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc. * Participated in other clinical trial within 3 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence rate of proliferative diabetic retinopathy, panretinal photocoagulation | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms scores of TCM | 12 weeks |
Countries
China
Outcome results
None listed