Efficacy of external application of oil and gel dosage forms of Aragvadhadi formulation in combination with Rasayana Churna in the management of Shwitra (vitiligo) - An open-labeled comparative clinical trial.

Abstract

Aragvadhadi Taila (ART) is one of the herbomineral formulations mentioned in Chakradatta indicated in Shwitra (vitiligo). Modification of Taila form into gel form reduces the risk of contamination in view of arsenical contents (Manahshila, Haratala) assures precise dose administration at desired site (by avoiding spreading). The gel is a comparatively acceptable dosage form than that of medicated oil. The aim of the study is to evaluate the comparative efficacy of Aragvadhadi formulation in Taila (ART: Aragvadhadi Taila) and gel (ARG: Aragvadhadi gel) dosage forms with the internal administration of Rasayana Churna in the management of Shwitra. The study was a randomized open labeled, involving 66 patients of Shwitra that were randomly divided into two groups. Patients registered in group A (n = 34) were treated with local applications of ART and group B (n = 32) with ARG for 2 months. Rasayana Churna (3 g), along with the equal quantity of honey and Ghrita was given twice a day after the meal in both groups. Wilcoxon signed-rank test was applied to evaluate the effect of therapy in the individual group for subjective criteria like vitiligo area scoring index score, size and number of patches, Rukshata (dryness), Saparidaha (burning sensation), Bahalatva (thickening), Kandu (itching) while the comparison of results between the groups for the same by applying Coefficient of Variation (CV). Group B showed better and consistent results in all signs and symptoms except Rukshata, Saparidaha in terms of Coefficient of Variation. In both the groups, statistically highly significant improvement was found in signs and symptoms of Shwitra such as Saparidaha, Kandu, size of patches and number of patches; however, the difference between the groups was statistically insignificant. Both the forms (ART, ARG) of Aragvadhadi formulation along with Rasayana Churna were found as a safe and effective treatment in vitiligo with significant pigment regeneration capacity as topical use for application over 2 months.