A Randomized, Multicenter, Double-Blind, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of a Polyherbal Formulation in Men With Erectile Dysfunction.

Introduction Erectile dysfunction (ED) is a prevalent condition impacting men worldwide, often causing significant reductions in quality of life, emotional well-being, and relationship satisfaction. ED currently affects approximately 100 million men worldwide, with its prevalence projected to rise to 320 million by 2025, particularly in developing nations. Notably, nearly half of all men aged 40 and above experience some degree of ED, underscoring its widespread impact on male health. Existing treatments, while available, frequently fall short in terms of efficacy and safety, underscoring the demand for innovative and safer therapeutic alternatives. Methods Eighty-five participants completed the study and were randomly assigned to receive either the test treatment (polyherbal formulation) or a placebo, utilizing a computer-generated randomization list. The study protocol included screening (up to 14 days prior), baseline assessment (Day 0), and follow-up visits at day 30, day 60, and day 90 (± 5 days), allowing for thorough monitoring of outcomes. Results The test group exhibited significantly greater improvements in erectile function (92.2% vs. 34.8%), along with enhancements in sexual desire, orgasmic function, intercourse satisfaction, and overall satisfaction compared to the placebo group. Quality of erection scores also showed marked improvement in the test group. Additionally, serum testosterone levels increased by 46.5% in the test group compared to a mere 3.3% in the placebo group. Adverse events were mild and occurred with similar frequency in both groups (9.3% vs. 9.5%). Overall, the test group demonstrated robust efficacy and a favorable safety profile, presenting a promising therapeutic option for the management of ED. Conclusion The in-vitro phosphodiesterase type 5 (PDE5) assay and clinical study demonstrate the effectiveness of test intervention in managing ED and improving sexual health, with a favorable safety profile. Its synergistic herbal ingredients enhance efficacy, making it a promising solution in the management of ED.