Efficacy of Prunella vulgaris on Male Lower Urinary Tract Symptoms: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Purpose

To evaluate the efficacy and safety of Prunella vulgaris (PV) extract in men with lower urinary tract symptoms (LUTS). Materials and Methods: In this 12-week, randomized, double-blind, placebo-controlled clinical trial, 80 men aged 40–75 years with moderate LUTS (International Prostate Symptom Score [IPSS] ≥8 and ≤19) were randomized to receive PV extract (600 mg/day) or placebo. The primary outcome was the change in total IPSS from baseline to week 12. Secondary outcomes included changes in IPSS subscores, quality of life (QoL), uroflowmetry, and prostate volume. Safety was assessed by adverse events and laboratory parameters.