Efficacy and Safety of Ginseng Berry Extract (SIRTBERRY™) in Treating Andropause Symptoms: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial
Abstract
Purpose This study aimed to evaluate the efficacy and safety of ginseng berry extract (GBE) (SIRTBERRY™) 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…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 116 participants or records.
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