Evaluation of adjunct effect of oral Ayurvedic or Homeopathic interventions with intra-lesional injection of verapamil in peyronie’s disease: An open-label, parallel group, randomized, active controlled trial

BACKGROUND: Peyronie's disease (PD) is a fibrotic disorder of the penile tunica albuginea causing curvature, pain, and erectile dysfunction, with significant psychosocial impact. Standard treatments, including intra-lesional verapamil, provide modest outcomes. Complementary approaches such as Ayurveda and Homeopathy have shown potential in fibrotic conditions. OBJECTIVE: To evaluate the adjunct effect of oral Ayurvedic or Homeopathic medicines combined with intra-lesional verapamil compared to standalone intra-lesional verapamil in men with PD. METHODS: This open-label, randomized, active-controlled, parallel-group trial was conducted at a tertiary care hospital in India. Sixty eligible men with PD were randomized (1:1:1) into three groups: Group A (Ayurveda + intra-lesional verapamil), Group B (Homeopathy + intra-lesional verapamil), and Group C (verapamil alone). The interventions continued for 12 weeks. Primary outcome was change in penile curvature. Secondary outcomes included plaque size, International Index of Erectile Function (IIEF-5), Peyronie's Disease Questionnaire (PDQ) domains, Patient Global Impression of Improvement (PGI-I), and safety. RESULTS: Fifty-five participants completed the study. All groups showed significant reductions in penile curvature, with greater mean improvement in Group A (-18°) and Group B (-16°) compared to Group C (-14°). Plaque size reduction was most pronounced in Group B. Erectile function improved significantly in Groups A and B, but not in Group C. PDQ domains and PGI-I scores improved more in adjunct groups, with 80% of Group A and 65% of Group B reporting meaningful global improvement, versus 35% in Group C. Adverse events were mild and self-limiting. CONCLUSION: Ayurvedic or Homeopathic add-on therapy showed suggestive or preliminary indications of improvement compared to standard therapy alone. These findings should be interpreted as hypothesis generating preliminary evidence, because of open-label design, absence of assessor blinding, and lack of sham oral control. Larger blinded, placebo-controlled trials are required to confirm efficacy.