Add-on Psoralea corylifolia mother tincture external application to individualized homeopathic medicines in treatment of vitiligo: open, randomized, pragmatic, pilot trial

ABSTRACT Background Vitiligo causes patchy hypo-pigmentation of skin and mucous membrane, with cosmetic and psychological effects. Studies showed Psoralea corylifolia (PC) having pigmentor property and individualized homeopathic medicines (IH) as a promising treatment option in vitiligo. This pilot trial was aimed at testing feasibility of future definitive trial comparing the effects of three treatment regimens – 1. IH, 2. PC mother tincture (MT) external application, and 3. IHPC in treatment of vitiligo. Methods An open, randomized (1:1:1), three parallel arms, pragmatic, pilot trial was conducted on 60 patients at the dermatology and Materia Medica outpatients of National Institute of Homoeopathy (NIH), India. Primary outcome was Vitiligo Area Scoring Index (VASI); and secondary outcomes were Vitiligo Quality of Life (VitiQoL) and Dermatological Life Quality Index (DLQI); assessed at baseline, 3rd month and 6th month. Intention-to-treat analysis was performed; intra-group and inter-group comparisons were made by Friedman and Kruskal-Wallis tests respectively. Results Five patients dropped out (IH: 2, PC: 2, IHPC: 1). Intra-group changes over 3 and 6 months were mostly statistically significant in all 3 outcomes (P Conclusion Definitive trial appeared feasible. All three regimens appeared equally effective and safe; still, small direction of effect towards PC and IHPC was observed. Being pilot trial, no definite conclusion could be drawn. Trial registration: CTRI/2018/04/013446.