Diabetic Retinopathy
Conditions
Interventions
control group:Zhixue Quyu Mingmu Tablet placebo + basic treatment (Calcium Dobesilate Tablets)
Treatment group:Zhixue Quyu Mingmu Tablets (National Medical Products Administration approval number: Z20025316) + basic treatment (Calcium Dobesilate Tablets)
Sponsors
Hebei Eye Hospital
Eligibility
Sex/Gender
All
Age
35 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) The target eye meets the Western diagnostic criteria for non-proliferative diabetic retinopathy and is confirmed to have fundus hemorrhage; (2) Meets the traditional Chinese medicine (TCM) syndrome differentiation criteria for liver-kidney yin deficiency and collateral stasis obstruction; (3) Diagnosed with type 2 diabetes mellitus with HbA1c = 10% at enrollment; (4) Age: 35–80 years both genders eligible; (5) Refractive media is sufficiently clear to allow fundus examination; (6) Informed consent form has been signed.
Exclusion criteria
Exclusion criteria: (1) Presence of severe retinal vein occlusion hypertensive retinopathy glaucoma cataract or any other condition that contraindicates pupil dilation; (2) Fundus hemorrhage caused by leukemia trauma or other non-diabetic etiologies; (3) Congenital ocular structural abnormalities or corneal disorders; (4) Severe diabetic complications such as diabetic nephropathy (CKD stage G5) diabetic neuropathy diabetic lower extremity arterial disease diabetic foot or severe impairment of cardiac hepatic or renal function or malignancy; (5) Target eye received laser photocoagulation within the past month or any ocular surgery within the past three months; (6) History of alcohol abuse or severe tobacco dependence within the past five years; (7) ALT or AST > 2 times the upper limit of normal or serum creatinine (Cr) > 1.5 times the upper limit of normal; (8) Women who are planning pregnancy currently pregnant or breastfeeding; (9) Known hypersensitivity to any component of the study medication; (10) Investigator considers the patient unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rate of fundus hemorrhage; | — |
Secondary
| Measure | Time frame |
|---|---|
| Foveal thickness change in visual acuity measured by the international standard visual acuity chart efficacy of TCM syndrome disappearance rate of individual symptoms; | — |
Countries
China
Contacts
Public ContactShi Huijun
Hebei Eye Hospital
Outcome results
None listed