Long-standing diabetes mellitus with or without diabetic retinopathy
Conditions
Interventions
Control Group:Conventional glucose-lowering treatment.
Ginaton? Group:Since joining the group, Jin Na Duo has been taken three times daily—morning, noon, and evening—2 tablets each time (40 mg per tablet), for a duration of 2 years.
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older, regardless of gender; 2.Meeting the diagnostic criteria for diabetes mellitus with glycated hemoglobin (HbA1c) =5 years without diagnosed diabetic retinopathy OR, according to the DR staging criteria proposed by the Group of Fundus Diseases, Ophthalmology Society of Chinese Medical Association in 2014, having at least one eye diagnosed with Stage I or II non-proliferative diabetic retinopathy (NPDR) without concomitant diabetic macular edema (DME); 4.Voluntarily signing the informed consent form;
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women; 2.Poorly controlled hypertension (defined as >=180/100 mmHg); 3.Patients with coexisting ocular pathologies, such as glaucoma or cataract; 4.Patients with severe impairment of cardiac, pulmonary, hepatic, or renal function, or coagulation disorders, e.g., alanine aminotransferase (ALT) >=2 times the upper limit of normal (ULN), aspartate aminotransferase (AST) >=2 ULN, total bilirubin (BIL) >=1.5 ULN, or estimated glomerular filtration rate (eGFR) <=30 mL/min/1.73 m^2; 5.Patients with comorbid psychiatric or neurological disorders; 6.Patients with a known allergy to any component of the investigational product; 7.Patients who received Ginkgo biloba extract treatment within the past 12 months; 8.Patients with a history of intraocular treatments, such as panretinal photocoagulation (PRP), and/or anti-vascular endothelial growth factor (VEGF) therapy, and/or ocular surgery; 9.Patients with a history of cardiovascular events or conditions requiring long-term anticoagulation therapy, such as deep vein thrombosis, pulmonary embolism, atrial fibrillation, or cardiac valve replacement; 10.Any contraindication that, in the investigator's judgment, could limit clinical assessment or treatment; 11.Concurrent participation in any other clinical trial; 12.Patients deemed by the investigator to be unsuitable for inclusion in this study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retinal and choroidal hemodynamic parameters; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin (HbA1c);Hemorheology;Renal Function;Peripheral Neuropathy;Fundus condition; | — |
Countries
China
Contacts
Public ContactKun Liu
Shanghai General Hospital
Outcome results
None listed