Safety and Efficacy of a Nutraceutical Formulation-Reproguard in the Management of Prostate-Associated Symptoms

Abstract

The prostate gland is essential to male reproductive health and is influenced by age, inflammation, and lifestyle factors that may contribute to conditions such as prostatitis, benign prostatic hyperplasia (BPH), and prostate cancer. Nutraceuticals with antioxidant, anti-inflammatory, and androgen-modulating properties have emerged as supportive strategies for maintaining prostate health. This Phase I pilot study evaluated the preliminary efficacy and safety of a multi-ingredient nutraceutical formulation containing Urtica dioica, β-sitosterol, lycopene, zinc sulphate, Camellia sinensis, vitamin D₃, and Punica granatum in male patients diagnosed with Sukrasthamba and Dourbalya. The open-label study was conducted over 30 days in ten participants aged 21–40 years. Clinical assessments were performed at baseline, day 15, and day 30. The treatment demonstrated favourable overall clinical outcomes, with 80% of patients showing very good improvement, 10% moderate improvement, and 10% mild improvement. No patients showed lack of response, and no adverse events or dropouts were reported, indicating good tolerability and acceptability. These findings suggest that the nutraceutical formulation is safe and potentially effective in managing prostate-associated symptoms.