A Randomized, Parallel group, Open Label, Active controlled Clinical study to Evaluate the Efficacy and Safety of Roghan-i-Baras in the management of Baras (Vitiligo)

Vitiligo is a cosmetic dermatological defect, but it has a very prominent social and psychological impact on the patient. It is a depigmenting skin disorder characterized by the selective loss of melanocytes,which in turn leads to pigment dilution in the affectedarea of the skin. Thecharacteristic lesion is totally amelanotic, non-scaly, chalky-white maculewith distinct margins. Vitiligo is a common dermatological as well as cosmetic and social problem with prevalence 1% to 2% ofthe world population .In India it is between 3% to 4%.The incidence of vitiligoas reported by various workersin different cities of India canbe 2.9% in Goa, 8.8% in Delhi. However most authors say that its incidence is around is 4% which is howeverdefinitely more as compared to worlds population of 1%. Several single and compound formulations have been used to treat vitiligo by many ancient Unani physicians, but some of them are not yet scientifically evaluated on modern parameters. Hence, this A Randomized, Parallel Group, Open Label, Active Controlled ClinicalStudy is planned to evaluate the Efficacy and Safety of Roghan-i-Baras in the Management of Baraá¹£ (Vitiligo). Participants fulfilling inclusion and exclusion criteria will receive either test or control drug as per randomization. In test group participants will start with Roghan-i-Baras and in control group participants will start with Methoxsalen 1% , for the duration of 16 weeks. Baseline and last follow up and laboratory investigations will be done.

Statistical analysis : After completion of the study, data obtainedwill be analysed statistically by using an appropriate statistical test to evaluate the significance of results. p<0.05will be considered significant.