Clinical study on the efficacy and safety of Tangningtongluo tablet in treating non proliferative diabetic retinopathy: the syndrome of yin asthenia generating intrinsic heat and eye collateral stasis

Ineye Hospital of Chendu University of TCM0 个研究点开始时间: 待定最近更新: 2023年2月20日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Ineye Hospital of Chendu University of TCM