Effect of Korean red ginseng on deep capillary plexus parameters in diabetic retinopathy: A prospective, randomized, double-blind clinical trial.

BACKGROUND

This prospective, randomized, double-blind clinical trial aimed to evaluate the effects of Korean Red Ginseng (KRG) extract on the retinal microvascular parameters in patients with diabetic retinopathy (DR).

METHODS

Patients with mild to moderate non-proliferative DR were randomized to receive KRG extract or placebo for 90 days. Outcomes included changes in the best-corrected visual acuity (BCVA), intraocular pressure (IOP), central macular thickness (CMT), and optical coherence tomography angiography (OCTA) parameters, including the foveal avascular zone, vessel length density (VLD), and perfusion index (PI) in the superficial and deep capillary plexuses (SCP and DCP, respectively). The incidence of proliferative DR or diabetic macular edema (DME) was also monitored.

RESULTS

Twenty-four patients were enrolled and 23 completed the study. The baseline BCVA, IOP, CMT, and OCTA parameters were comparable between the groups (all p > 0.05). No significant changes were observed in BCVA, CMT, DR severity stage, or incidence of DME over the 3-month follow-up period in either group. Significant group × time interaction effects were observed for inferior DCP VLD (p = 0.011) and for PI in the superior (p = 0.044) and inferior (p = 0.026) DCP regions. No significant interaction effects were identified for SCP parameters or other DCP subfields. No adverse events were reported.

CONCLUSIONS

KRG extract was associated with short-term, region-specific changes in OCTA-derived DCP perfusion metrics over 3 months. These findings reflect alterations in OCTA-derived microvascular parameters and do not establish modification of clinical outcomes such as DR progression or the development of DME.

TRIAL REGISTRATION: Clinical Research Information Service, #KCT0010991.