Efficacy and Safety of Pallrywyn Forte in Functional Erectile Dysfunction: An Open-Label Single-Arm Clinical Trial

Background: Erectile dysfunction (ED) is a prevalent male sexual disorder affecting over 150 million men worldwide, with Indian prevalence estimates of 10–30% in men above 40 years. While phosphodiesterase type 5 inhibitors are effective, their use is limited by contraindications, adverse effects, and reduced efficacy in functional ED, where psychosocial and lifestyle factors predominate. Herbal formulations are increasingly explored as alternatives, but robust clinical evidence remains limited. Objective: To evaluate the efficacy and safety of Pallrywyn Forte, a proprietary polyherbal formulation, in men with functional ED. Methods: This open-label, single-arm, pre–post clinical trial, enrolled 50 men aged 19–59 years with functional ED of 2–4 months’ duration after a four week treatment free run in. Participants received Pallrywyn Forte (two tablets twice daily) for four weeks. The primary endpoint was change in International Index of Erectile Function erectile function domain (IIEF EF). Secondary endpoints included SEP 2, SEP 3, Erection Hardness Score (EHS), Global Assessment Question (GAQ), intravaginal ejaculatory latency time (IELT), performance anxiety, and safety. Results: Mean IIEF EF improved from 14.2 ± 3.1 at baseline to 20.1 ± 4.0 at Week 4 (mean difference +5.9; 95% CI: 4.8–7.0; p < 0.001). Responder analysis showed 68% achieved ≥4 point improvement. SEP 2 and SEP 3 success rates increased by 29 percentage points each (p < 0.001). GAQ improvement was reported by 72%, EHS ≥3 rose from 38% to 70%, IELT increased modestly (+0.8 min; p = 0.02), and performance anxiety decreased significantly. Pallrywyn Forte was well tolerated; 16% reported mild adverse events, with no serious events. Conclusion: Pallrywyn Forte demonstrated promising efficacy and safety in functional ED, supporting further randomized controlled trials to validate its role in ED management.