NCT07236645

Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy

Efficacy and Safety of Ginkgo Biloba Extract EGb761® in Patients With Diabetic Retinopathy: A Single-Center, Open-Label, Parallel-Group Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-center, open-label, parallel-controlled trial, scheduled to commence in October 2025 at the outpatient and inpatient departments of Shanghai General Hospital. Eligible patients with diabetes mellitus and/or non-proliferative diabetic retinopathy (NPDR), who meet the inclusion and exclusion criteria, will be recruited. General and disease-related information will be collected. All eligible participants will be required to voluntarily sign an informed consent form after fully understanding and accepting the study. Successfully enrolled subjects will be randomly assigned to the Ginaton group or the conventional treatment group, and will receive the corresponding interventions as specified in the study protocol. Follow-up assessments will include blood pressure, blood glucose, glycated hemoglobin, blood lipids, hemorheological parameters, glomerular filtration rate, microalbuminuria, nerve conduction velocity by electromyography, visual acuity, wide-field fundus photography, quality of life (SF-36 questionnaire), and adverse events. The study aims to evaluate the efficacy and safety of ginkgo biloba extract tablet in preventing the development of diabetic retinopathy in patients with long-standing diabetes, as well as in treating patients with mild to moderate NPDR without concomitant diabetic macular edema (DME).

Conditions

• Non-proliferative Diabetic Retinopathy (NPDR)

Interventions

Type	Name	Description
DRUG	Ginaton (ginkgo biloba extract tablet)	Patients in the Ginaton arm, in addition to receiving standard treatment, were administered Ginaton orally at a dose of two tablets (40 mg/tablet) three times daily (after morning, noon, and evening meals) for 2 years, starting from enrollment
OTHER	standard treatment	standard treatment

Timeline

• Start date: 2025-11-20
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-11-19
• Last updated: 2025-11-19