Comparative clinical trial to evaluate the effect of Arjunadi cream in Ahiputana

This study is planned as an open-label, randomized controlled clinical trial to evaluate and compare the therapeutic efficacy of Arjunadi Cream with Panchavalkala Ointment in the management of Ahiputana in children up to one year of age. The trial is designed to generate clinical evidence regarding the effectiveness, safety, and acceptability of a classical Ayurvedic formulation modified into a cream dosage form for pediatric use.

A total of 120 eligible infants will be recruited from the OPD and IPD of the Kaumarabhritya department and randomly allocated into two equal groups. Group A will receive Panchavalkala Ointment, while Group B will be treated with Arjunadi Cream. Both interventions will be applied locally in the affected area thrice daily for a duration of seven days. The Arjunadi Cream is prepared as per standard operating procedures using Arjuna, Kadamba, Kustha, and Shuddha Gairika, incorporated into a Sikta Taila base, ensuring uniformity, stability, and ease of application.

Clinical assessment will be carried out on day 0, day 4, day 8, and day 15 using standardized subjective and objective parameters. These include evaluation of pain using the FLACC Pain Assessment Scale, itching severity, discharge, erythema, and papulo-vesicular lesions using the Diaper Dermatitis Severity Scale. Medication compliance will be monitored through caregiver instructions and follow-up verification. Safety assessment will include continuous monitoring for any adverse drug reactions throughout the study period.

The primary outcome measure is the reduction in the overall severity score of Ahiputana following treatment, while secondary outcomes include improvement in individual clinical parameters, tolerability of the formulation, and caregiver compliance. Statistical analysis will be performed using appropriate tests to compare intra-group and inter-group outcomes.

The study aims to establish whether Arjunadi Cream is equally or more effective than Panchavalkala Ointment and to support its potential role as a safe, cost-effective, and child-friendly topical Ayurvedic formulation in pediatric clinical practice.