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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginaton (ginkgo biloba extract tablet) | Experimental |
| |
| Control | Other | standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginaton (ginkgo biloba extract tablet) | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal Vessel Density | The difference between groups in the change of retinal vessel density from baseline within 2 years of treatment (at month 24), assessed by OCTA. | 2 years |
| Vessel Length Density | The difference between groups in the change of vessel length density from baseline within 2 years of treatment (at month 24), assessed by OCTA. | 2 years |
| Vascular Index | The difference between groups in the change of vascular index from baseline within 2 years of treatment (at month 24), assessed by OCTA. | 2 years |
| Perfusion Area | The difference between groups in the change of perfusion area from baseline within 2 years of treatment (at month 24), assessed by OCTA. | 2 years |
| Choroidal Vessel Volume | The difference between groups in the change of choroidal vessel volume from baseline within 2 years of treatment (at month 24), assessed by OCTA. | 2 years |
| Foveal Avascular Zone Area | The difference between groups in the change of foveal avascular zone area from baseline within 2 years of treatment (at month 24), assessed by OCTA. | 2 years |
| Stromal Volume | The difference between groups in the change of stromal volume from baseline within 2 years of treatment (at month 24), assessed by OCTA. |
| Measure | Description | Time Frame |
|---|---|---|
| The percentage of glycated hemoglobin (HbA1c) | Differences in the percentage of glycated hemoglobin (HbA1c) between the two groups over the 2-year treatment period. | 2 years |
| Urinary Albumin-to-creatinine Ratio (UACR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kun Liu | Contact | +86 18917989522 | drliukun@sjtu.edu.cn |
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|
| standard treatment | Other | standard treatment |
|
| 2 years |
| Stromal Index | The difference between groups in the change of stromal index from baseline within 2 years of treatment (at month 24), assessed by OCTA. | 2 years |
Between-group difference in urinary albumin-to-creatinine ratio (UACR) during the 2-year treatment period.
| 2 years |
| Estimated Glomerular Filtration Rate (eGFR) | Between-group difference in urinary estimated glomerular filtration rate (eGFR) during the 2-year treatment period. | 2 years |
| Motor Nerve Conduction Velocity (MNCV) | Differences in motor nerve conduction velocity (MNCV) of the median and common peroneal nerves from baseline at each visit over the 2-year treatment period. | 2 years |
| Diabetic Retinopathy Severity Scale (DRSS) score | Baseline ETDRS DRSS: None (level 10); Mild to moderate nonproliferative DR (levels 14, 15, 20, 35, and 43); Moderately severe/severe nonproliferative DR (levels 47 and 53); Mild/moderate/high-risk/advanced proliferative DR (levels 61, 65, 71,75, 81, and 85) | 2 years |
| 36-item Short-Form (SF-36) score over the 2-year treatment period | Differences in quality of life scores based on the 36-Item Short Form Health Survey between the two groups over the 2-year treatment period.The score for each of the eight health domains and the two summary measures ranges from 0 to 100.A higher score indicates a more favorable health state. | 2 years |
| Whole Blood Viscosity | The between-group difference in whole blood viscosity (a hemorheological parameter) during the 2-year treatment period. | 2 years |
| Plasma Viscosity | The between-group difference in plasma viscosity (a hemorheological parameter) during the 2-year treatment period. | 2 years |
| Hematocrit | The between-group difference in hematocrit (a hemorheological parameter) during the 2-year treatment period. | 2 years |
| Fibrinogen | The between-group difference in fibrinogen (a hemorheological parameter) during the 2-year treatment period. | 2 years |
| Sensory Nerve Conduction Velocity (SNCV) | Differences in sensory nerve conduction velocity (SNCV) of the median and superficial peroneal nerves from baseline at each visit over the 2-year treatment period. | 2 years |
| ID | Term |
|---|---|
| C526713 | ginaton |
| C063170 | Ginkgo biloba extract |
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