Pharmaceutico Analytical and Clinical Evaluation of Modified Dosage Forms (Lepa guti) of Varun Twak Lepa and Krushnatiladi Lepa in Vyanga (Melasma): A Research Protocol for Randomised Controlled Trial

Introduction: Vyanga, also referred to as melasma, is a prevalent disorder characterised by skin discoloration on the face. According to Ayurveda, Acharya Sushruta and Vagbhata described Vyanga as one of the Kshudra Rogas. Melasma is a related pigmentary disease characterised by symmetrical hyperpigmented macules on the face. Vyanga has been treated in Ayurveda through antah-parimarjana (internal therapy) and bahi-parimarjana chikitsa (external therapy), respectively. Need of the Study: Vyanga, also known as melasma, is not a life threatening condition, but it can significantly impact an individual’s appearance. Therefore, it is essential to explore effective management options. Modern treatments typically involve the use of topical steroids and antiseptics, which can lead to various side-effects such as irritation and rashes. In Ayurveda, several Shodhana (purification) and Shamana (alleviating) therapies are recommended for managing Vyanga. However, there are limitations regarding the use of Shodhana therapies in pregnant women, making Shamana therapies more preferable in such cases. Krushnatiladi Lepa, described in Raja Martanda, is noted for its properties, including Kusthaghna (antidermatological), Kandughna (anti-itch), Raktashodhaka (blood-purifying), Twak Prasadaka (skinnourishing) and Varnyakara (skin-toning). Despite its potential benefits, no studies have assessed its efficacy in treating Vyanga. Aim: To conduct a pharmaceutical and analytical evaluation of modified dosage forms (Lepa guti) of Krushnatiladi Lepa and Varun Twak Lepa, as well as, to assess their clinical efficacy in managing Vyanga (melasma). Materials and Methods: A randomised double-blind, controlled clinical trial will be conducted Department of Rasa Shastra and Bhaishajya Kalpana, Mahatma Gandhi Ayurved College and Research Centre (MGACH and RC), Salod (H), Wardha, Maharashtra, India, from August 2024 to August 2025. A total of 62 patients aged between 18 years and 50 years with typical symptoms of Vyanga (melasma) will be selected from the Department of Kayachikitsa Outpatient Department (OPD) and Inpatient Department (IPD) and peripheral camps and divided equally into two groups. In group A (control group), Varun Twak Lepa guti will be administered for local application with cow’s milk once a day, whereas in group B (interventional group), Krushnatiladi Lepa guti for local application with cow’s milk once a day will be given. The parameters assessed will include Shyavata (discoloration), Parush Sparsha (dryness), Daha (burning sensation), Kandu (itching), Snigdhata (oiliness), size of patches, Von Luschan’s colour scale, and Melasma Severity Index (MSI) score. For statistical analysis, paired and unpaired t-tests will be applied for intragroup and intergroup compariso