A comparative clinical trial to assess the effect of kusthkalanal cream ang kusthakalanal tail in shvitra with special refrence to bhrajak pitta

Dissertation titled A Comparative Clinical Trial to Assess the Efficacy of Kusthakalanal Cream and Kusthakalanal Tail in Shvitra with Special Reference to Bhrajaka Pitta is being conducted in the Department of Kriya Sharir at the National Institute of Ayurveda, Jaipur.

Shvitra, correlated with vitiligo in modern dermatology, is a depigmentary skin disorder described under Kushtha in Ayurveda and associated with vitiation of Bhrajaka Pitta. Vitiligo has a prevalence ranging from 0.25% to 4% in India, with higher rates reported in Rajasthan and Gujarat. Despite multiple treatment approaches, there is a need for effective, patient-friendly topical therapies.

This study aims to compare the clinical efficacy of Kusthakalanal Cream (a newly formulated cream using Kusthakalanal Tail as the active ingredient) and Kusthakalanal Tail (classical oil formulation mentioned in Gadnigraha) in the management of Shvitra.

It is a randomized, open-label, comparative interventional Phase II clinical trial involving 40 patients divided into two groups: Group A (20 patients): Kusthakalanal Cream (topical application twice daily)Group B (20 patients): Kusthakalanal Tail (topical application twice daily)

The duration of treatment is 90 days, with follow-up assessment. The primary outcome measure is improvement in the Vitiligo Area Severity Index (VASI) score. Secondary assessment includes classical Ayurvedic signs and evaluation of Bhrajaka Pitta involvement.

The study intends to scientifically evaluate whether the cream formulation offers better absorption, compliance, and therapeutic effectiveness compared to the traditional oil preparation. The findings may help bridge traditional Ayurvedic formulations with modern dermatological applications and provide improved patient-centered management strategies for Shvitra.