Diabetic retinopathy
Conditions
Interventions
Control:Calcium Salicylate Tablets + Zhangyanming Tablets Simulated Tablets
Experimental group:Calcium Salicylate Tablets + Zhangyanming Tablets
Sponsors
Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: (1) Patients who meet the diagnostic criteria for type 2 diabetes and diabetic retinopathy, with diabetic retinopathy stage being non-proliferative diabetic retinopathy (NPDR), and with mild and moderate grades; (2) Meet the diagnostic criteria of traditional Chinese medicine: 1) history of diabetes; 2) varying degrees of vision loss, floating black shadows in front of the eyes, or distorted vision; 3) fundus bleeding and exudation; 4) TCM diagnosis of liver and kidney deficiency and failure of the ocular meridians; (3) The best corrected visual acuity (BCVA) of the target eye is = 34 points (ETDRS visual acuity scale, equivalent to a score of 20/200, decimal 0.1); (4) The patient's age is 18 to 85 years old (inclusive); (5) Glycated hemoglobin (HbA1c) is = 8.5%; (6) Agree to participate in this clinical study and voluntarily sign the informed consent form. Note: If only one eye meets the inclusion criteria, it can be used as the subject. If both eyes meet the criteria, the following principles are used to determine: 1) When the fundus conditions of both eyes are at different stages, the more severe eye is selected as the target observation eye; 2) When the fundus conditions of both eyes are at the same stage, the eye that is more cooperative during clinical operations is selected as the target observation eye.
Exclusion criteria
Exclusion criteria: (1) Patients with macular edema requiring anti-VEGF treatment; (2) Patients with other ocular diseases, such as retinal artery or vein occlusion, retinal detachment, uveitis, glaucoma, corneal ulcer, cataract affecting fundus examination, optic nerve diseases, and high myopia with fundus changes; (3) Patients whose target eye has undergone full retinal laser photocoagulation treatment; (4) Patients who have used drugs for treating diabetic retinopathy within the past 2 weeks, such as plasminogen activator, Qiming Granules, Shuangdanmingmu Capsules, Compound Danshen Dropping Pills, Tongluomingmu Capsules, etc.; (5) Patients whose target eye has undergone internal eye surgery or procedures within the past 3 months, such as glaucoma, vitreous, or retinal surgery; (6) Patients with severe primary diseases such as respiratory, cardiovascular, cerebrovascular, endocrine, digestive, and hematological systems, or suffering from severe mental disorders; (7) Patients with severe liver or kidney diseases, or abnormal liver or kidney function tests (ALT, AST = 1.5 times the upper limit of normal, SCr > upper limit of normal); (8) Patients allergic to the test drugs or their components; (9) Patients who have participated in other clinical trials within the past 1 month; (10) Patients judged by the investigator to be unsuitable for this research project.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Optimal corrected vision; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin value;Traditional Chinese Medicine Syndrome Score;The changes and progression rate of DR Classification from baseline by ETDRS classification method (quantitative analysis of fundus microhemangioma, hemorrhage and exudation);The OCTA examines the changes in the macular region of the retina compared to the baseline (including macular foveal retinal thickness, retinal volume, FAZ area, FAZ perimeter, and FAZ shape index).; | — |
Countries
China
Contacts
Public ContactXie Xiaofeng
Affiliated Eye Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed