An Open-Label Randomized Pilot Clinical Trial to Evaluate the Efficacy of Shadanga Kwatha Guggulu and Darvyadi Rasakriya on Vernal Keratoconjunctivitis

Vernal Keratoconjunctivitis (VKC) is a chronic, recurrent bilateral allergic inflammation affecting 3 to 10 percentage of school age children in tropical and subtropical regions, characterized by intense itching, photophobia, and papillary formations. The disease poses significant challenges due to its chronic nature, seasonal exacerbations, and potential sight threatening complications including corneal scarring, keratoconus, and amblyopia. Current management relies heavily on corticosteroids, mast-cell stabilizers, and immunosuppressants, yet faces critical limitations. The most prominent challenge is steroid dependence and resistance, with prolonged use carrying substantial risks including cataract formation, glaucoma, and growth suppression in paediatric patients. Alternative agents like cyclosporine-A present challenges of high cost, complex administration, and potential systemic toxicity, while mast-cell stabilizers demonstrate limited efficacy in moderate to severe cases. The chronic recurrent nature necessitates long term therapy, yet most available options are unsuitable for extended use due to adverse effect profiles, creating an urgent need for safe, effective, and sustainable treatment alternatives.

In Ayurvedic medicine, VKC correlates with Kapha-Pitta predominant Abhishyanda and Pilla Roga. Sadanga Kwatha Guggulu and Darvyadi Rasakriya are classical formulations specifically indicated for inflammatory ocular conditions including sopha, paka, akshishula, daha, and raga. These formulations possess documented anti-inflammatory, immunomodulatory, and antioxidant properties, with traditional texts indicating their suitability for long term use in chronic conditions. Despite centuries of empirical use, these formulations have not been evaluated through rigorous controlled trials for VKC management. This research investigates whether these classical Ayurvedic formulations can provide effective, safe therapeutic alternatives, potentially addressing critical gaps in current treatment paradigms and offering improved long-term management strategies for paediatric VKC patients without the limitations and complications associated with conventional pharmacotherapy.