Diabetic Retinopathy
Conditions
Interventions
TCM Group:Study group(combined therapy with Intervention of TCM): Basic therapy & treatment for both Xu and Yu zheng. 1 Therapy for DM: To control blood glucose, blood pressure, and serum lipid throug
Control group:Control group Basic therapy & placebo 1Therapy for DM: To control blood glucose, blood pressure, and serum lipid through drug, dietary management, exercise and education. 2placebo, Usage
Sponsors
Chengdu University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
35 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with diabetes mellitus; 2. 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); 3. Diagnosed with the syndrome and signs of TCM; 4. HbA1C<=8.0%; 5. Ages ranged from 35 to 75 years; 6. Joined in the test voluntarily and signed the Informed consent by GCP regulation.
Exclusion criteria
Exclusion criteria: 1. Complicating severe vitreous hemorrhage, or requiring laser and vitreotomy treatment; 2. The patients who have been received the therapy of Retina laser photocoagulation; 3. The patients whose dioptric media is so turbid that hard to evaluate the fundus picture; 4. DMKA or other acute metabolic disturbance, or complicating severe acute infection within a month; 5. Having any allergic reaction to some drugs, food and pollen etc. or hypersensitiveness 6. Pregnant or breast feeding; 7. Combined with primarily severe diseases such as cardiovascular, hepatic, renal illness, hemopoietic system disease, and psychosis; 8. Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.; 9. Participated in other clinical trial within 3 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence rate of proliferative diabetic retinopat; | — |
Secondary
| Measure | Time frame |
|---|---|
| OCT;Visual Function;FFA, FERG, OPs, PVEP;Change of Symptoms scores of TCM;Vision acuity, Funduscopy, Fundus photograph;Quality of life; | — |
Countries
China
Contacts
Public ContactDuan junguo
Outcome results
None listed