A randomised, standard controlled clinical trial of Unani formulation (Kundur, Aelwa, Dam-ul-Akhawain, Anzaroot) in non-healing ulcers

Introduction Non-healing ulcers remain a therapeutic challenge. Traditional Unani formulations are widely used clinically for chronic wounds but require rigorous comparative evaluation. We evaluated a Unani topical formulation versus standard 5% povidone-iodine ointment in non-healing ulcers. Methods A randomised, standard-controlled pilot clinical trial included 44 eligible patients randomised 1:1 to the study formulation (n=22) or control group (n=22). Dressings were applied on alternate days for 45 days. Primary outcomes were complete healing and percentage reduction in wound area. Secondary outcomes included granulation, epithelialization, pain (VAS), depth, Wagner grade, and surrounding skin condition. Assessments were performed at baseline and days 15, 30, and 45. Intention-to-treat analysis was conducted using parametric/non-parametric tests, with P<0.05 considered significant. Results At day 45, complete healing occurred in 95.5% (21/22) of patients in the test group and 72.7% (16/22) in the control group; the between-group difference was not statistically significant (P=0.07). Mean wound area decreased from 24.23±14.38 to 0.95±1.84 cm² in the test group and from 17.77±17.22 to 1.68±2.68 cm² in the control group (within-group P<0.001 for both). Granulation and epithelialization improved markedly in both groups, with post-treatment granulation of 98.27±3.45% and 95.48±7.34% in the test and control groups, respectively. Conclusion The Unani formulation was safe and showed encouraging clinical improvement. Although complete healing was more frequent in the Unani group, the primary between-group difference was not statistically significant. Given the pilot design and limited sample size, findings are preliminary and require confirmation in larger, adequately powered randomised controlled trials.