Efficacy of Arjunadi Cream in Ahiputana (Diaper Dermatitis) in Infants: A Randomized Comparative Controlled Clinical Study Protocol

Introduction: Ahiputana, clinically correlated with diaper dermatitis, is a common inflammatory skin condition in infants caused by prolonged exposure to moisture, urine, and faeces.In Ayurveda, it is described under Kshudra Rogas, primarily involving vitiation of Kapha, Pitta, and Rakta, leading to symptoms such as erythema, itching, discharge, and lesions.The prevalence ranges from 4% to 35% in early childhood.Conventional topical therapies provide symptomatic relief but may be associated with adverse effects on prolonged use.Arjunadi Lepa, possessing anti-inflammatory and wound-healing properties, is explored in a modified cream form to enhance therapeutic efficacy and acceptability.Methods: A randomized, open-label, parallel-group clinical trial will be conducted on 120 infants diagnosed with Ahiputana.Participants will be randomly allocated into two groups (n=60 each).Group A will receive Panchavalkala ointment, and Group B will receive Arjunadi cream, applied locally thrice daily for 7 days.Primary outcomes will be assessed using the Diaper Dermatitis Severity Scale, while secondary outcomes include the FLACC scale for pain and ItchyQuant scale for itching, evaluated on Day 0, 8 and 15.Expected Outcomes: The study is expected to demonstrate significant improvement in both groups, with Arjunadi cream showing enhanced efficacy in reducing erythema, itching, discharge, and lesions.Improved patient compliance and faster healing response are anticipated.