1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [sohamshirole99@gmail.com].
   


6. For how long will this data be available start date provided 30-09-2027 and end date provided 30-09-2028?
   Response (Others) -  One year of post publication of research


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - Nil

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.