diabetic retinopathy
Conditions
Interventions
Control group:calcium hydroxyphenyl sulfonate capsule (Dasamine)
Experimental group:Tangningtongluo tablets
Sponsors
Ineye Hospital of Chendu University of TCM
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the diagnostic criteria for type 2 diabetes; 2. Conform to the diagnosis of non-proliferative diabetic retinopathy, graded as mild and moderate patients; 3. The target eye's best corrected visual acuity (BCVA) >= 34 points (ETDRS vision chart, visual acuity is equivalent to score 20/200, decimal 0.1); 4. Patients who meet the syndrome differentiation criteria of TCM yin deficiency and internal heat and stasis of the eyes and collaterals; 5. HbA1C<=9%; 6. Aged 18 to 75 years (including boundary values); 7. Informed consent, volunteer experiment. The process of obtaining informed consent conforms to GCP regulations.
Exclusion criteria
Exclusion criteria: 1. Diabetic retinopathy combined with severe vitreous hemorrhage, or other patients requiring panretinal laser treatment and vitrectomy; 2. Patients who have undergone panretinal laser photocoagulation; 3. It is difficult to evaluate fundus images due to the opacity of the refractive medium; 4. Patients with acute metabolic disorders such as diabetic ketoacidosis or severe acute infection within the past 1 month; 5. Combined with other serious complications of diabetes, such as diabetic gangrene, etc.; 6. Those who are allergic to Tangning Tongluo or calcium dobesilate or its components; 7. Women who are planning to become pregnant, pregnant or breastfeeding; 8. Patients with serious primary diseases such as cardiovascular, liver, kidney and hematopoietic system, mental illness; 9. Abnormal liver and kidney function (ALT or AST >= 2 times the upper limit of the normal value, Cr > 1 times the upper limit of the normal value), diabetic nephropathy diagnosis stage 4 or above; 10. Patients with eye diseases such as glaucoma, uveitis, optic neuropathy and severe cataract; 11. Those who have participated in other clinical trials within the past 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| digital x-ray system progression rate;Best corrected visual acuity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Retinal macular optical coherence tomography angiography;Glycated hemoglobin;Retinal blood oxygen saturation;Routine eye examination;Efficacy of traditional Chinese medicine syndrome.;Fundus photography; | — |
Countries
China
Contacts
Public ContactDuan Junguo
Yinghai Eye Hospital of Chengdu University of Chinese Medicine
Outcome results
None listed