Efficacy and Safety of Ginseng Berry Extract (SIRTBERRYTM) in Treating Andropause Symptoms: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Purpose: This study aimed to evaluate the efficacy and safety of ginseng berry extract (GBE) (SIRTBERRYTM) in treating andropause symptoms in aging men. Materials and Methods: In this randomized, double-blind, placebo-controlled trial, 116 men with andropause symptoms were assigned to receive either 700 mg/day GBE or placebo for 8 weeks. The primary efficacy variables included changes in the aging male symptoms (AMS) scale and improvement rate as per the androgen deficiency in aging male (ADAM) questionnaire, from the baseline. Secondary efficacy measurements included changes in the total and free testosterone levels, serum lipid levels, International Index of Erectile Function (IIEF) scores, International Prostate Symptom Score (IPSS), and various hormonal and metabolic markers. Results: The GBE group exhibited significant improvements in AMS scores, ADAM improvement rates, and IIEF scores compared to the placebo group. Specifically, the GBE group showed a 70% improvement in ADAM scores versus a 47.83% improvement in the placebo group (p=0.0376), and a greater reduction in AMS scores (p=0.0205). Significant enhancements were observed in erectile function, with the IIEF scores improved more in the GBE group (p=0.0334), particularly in the erectile function domain (p=0.0290). No serious adverse event was reported, and the safety profile of GBE was found to be comparable to that of placebo. Conclusions: GBE significantly improved andropause symptoms, including sexual function, and demonstrated a favorable safety profile, suggesting its potential as a safe and effective alternative treatment for testosterone deficiency syndrome. Further research regarding its long-term benefits and applicability to broader populations is warranted.