A randomized controlled clinical study to evaluate efficacy and safety of a topical Unani formulation in the management of Nār Fārsī (Eczema)

Abstract

Nar Farsi (Eczema) is a very common skin inflammatory disorder. Its prevalence varies according to age groups and country to country. The Unani system of medicine offers its successful management. In this study, efficacy and safety of a topical Unani formulation was assessed and compared with a standard drug. A prospective, non inferiority, randomized, active controlled and parallel group study was designed to study 60 participants of eczema (30 participants in each group). The Unani formulation Marham Safeda Kafoori was studied as a test drug for 6 weeks versus allopathic medicine Clobetasol Propionate in the study. The study findings suggested that the Unani formulation was non inferior to Clobetasol Propionate in terms of percentage of reduction in itching, oozing, exudation, erythema, lichenification and cracking at 6 weeks of treatment. It was observed that the difference of the mean±SD of SASSAD Score was measured as 12.83±4.76 and 14.13±5.27 in test and control groups respectively. The result was analysed as per protocol and it was found that the efficacy of the Unani formulation was statistically significant (p<0.001). This study concluded that the Unani formulation was safe and effective in the treatment of eczema.