Efficacy and safety of low-dose red ginseng oil (RXGIN) in men with moderate lower urinary tract symptoms: a randomized, double-blind, placebo-controlled trial

Background Previous studies demonstrated that 1000 mg/day of red ginseng oil (RXGIN) improved lower urinary tract symptoms (LUTS) in men. However, the high dose may limit long-term compliance and cost-effectiveness. This study aimed to evaluate the efficacy and safety of a lower dose (500 mg/day) of RXGIN in men with moderate LUTS. Materials and methods In this randomized, double-blind, placebo-controlled trial, 100 men aged ≥50 years with moderate LUTS (International Prostate Symptom Score [IPSS] = 8–19) were enrolled and randomly assigned (1:1) to receive RXGIN (500 mg/day) or placebo for 12 weeks. The primary endpoint was the change in total IPSS score from baseline. Secondary outcomes included the International Index of Erectile Function (IIEF-5), prostate-specific antigen (PSA), serum hormones, maximum urinary flow rate (Qmax), and postvoid residual volume (PVR). Safety was assessed via laboratory tests and adverse events. Results Eighty-nine participants (RXGIN = 45, placebo = 44) completed the study. At 12 weeks, the RXGIN group showed a significant reduction in total IPSS (6.76 ± 2.40 vs. 11.64 ± 3.00, P < 0.0001) and improvements in both voiding and storage subscores, as well as quality of life. The IIEF-5 total and subdomain scores (erectile, orgasmic, and intercourse satisfaction) were also significantly improved in the RXGIN group. No significant differences were observed in PSA, testosterone, dihydrotestosterone, Qmax, or PVR. No serious adverse events occurred. Conclusions Daily administration of 500 mg of RXGIN for 12 weeks significantly improved LUTS and sexual function without safety concerns. These findings suggest that low-dose RXGIN may provide comparable benefits to the higher dose while enhancing treatment adherence and tolerability.