A Randomized Comparative Clinical Study to evaluate efficacy of Local application of Yavadi cream and Yavadi lepa in the Treatment of Vyanga w.s.r to Melasma

This randomized comparative clinical study is planned to evaluate and compare the efficacy of Yavadi Cream and Yavadi Lepa in the management of Vyanga (Melasma). Vyanga is described in Ayurveda as a Raktapradoshaja and Kshudra Roga, characterized by painless, thin, bluish-black patches on the face, mainly caused due to Vata–Pitta vitiation triggered by factors like anger and mental stress. Although considered a minor disease in classics, Vyanga has major cosmetic and psychological impact in modern society.

In contemporary dermatology, melasma is commonly managed with topical agents, chemical peels, and lasers, which may cause adverse effects on prolonged use. Traditional lepa formulations, though effective, have limitations such as poor shelf life, inconvenience in preparation, and patient non-compliance. Hence, this study proposes a modified cream formulation of Yavadi Lepa to overcome these drawbacks and evaluates whether it offers comparable or superior efficacy.

A total of 120 subjects will be enrolled considering a 20% dropout rate, to obtain 50 completed subjects in each group. Subjects will be randomly allocated into two groups:

Group A: Yavadi Cream (local application)

Group B: Yavadi Lepa (local application)

Assessment will be carried out using both objective and subjective parameters. The primary assessment tool is the Modified Melasma Area and Severity Index (mMASI). Secondary assessment tools include the Taylor Hyperpigmentation Scale, dermoscopic evaluation, and standardized photographic documentation. Clinical response will be graded as excellent, good, moderate, or mild based on percentage improvement.