A randomized trial of homeopathic Dioscorea villosa in acute paronychia in adults
Description
Acute paronychia is a painful inflammatory condition for which evidence regarding homeopathic treatment remains limited. This trial evaluated the efficacy and safety of individualized Dioscorea villosa in adults with acute paronychia. In this 21-day, randomized, double-blind, placebo-controlled trial, 108 adults with acute paronychia were allocated in a 2:1 ratio to individualized Dioscorea villosa (n = 72) or placebo (n = 36), alongside standardized supportive care. The primary efficacy estimand was time to recovery and achievement of at least a 30% reduction in pain VAS from baseline. Recovery was analyzed using Kaplan–Meier methods and adjusted Cox regression, with a complementary Royston–Parmar parametric survival model. Longitudinal pain trajectories were assessed as a secondary analysis. Post hoc sensitivity, rescue medication, subgroup, and exploratory analyses were undertaken to assess robustness and potential heterogeneity. Safety was monitored. Of 120 individuals screened, 108 were randomized and 98 completed follow-ups; all randomized participants were retained in the intention-to-treat population. Recovery occurred earlier with Dioscorea villosa than placebo (adjusted hazard ratio [aHR] 1.89, 95% CI 1.14–3.13; p = 0.014). The complementary Royston–Parmar analysis showed a similar difference in recovery trajectories (p = 0.017). In contrast, the longitudinal MMRM analysis did not demonstrate a statistically significant between-group difference in mean pain trajectories (p = 0.471). Sensitivity analyses using multiple intention-to-treat models produced broadly consistent estimates. Exploratory causal, rescue-medication, subgroup, and potency analyses were directionally informative but were not considered confirmatory. Three mild, transient adverse events occurred in the Dioscorea villosa group; all resolved within 1 day, and no serious adverse events were reported. Individualized Dioscorea villosa was associated with earlier attainment of statistically significant and clinically meaningful pain relief during 21 days of treatment. The consistency of the primary finding across complementary analyses supports further evaluation by larger, independent trials. CTRI/2026/01/101338
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Institutions
- West Bengal University of Health SciencesWest Bengal, Kolkata