Study of Potential Immunomodulatory Activity of Dashmoola Katutrayadi Syrup in the Management of Pediatric Respiratory Disorders – A Open-label Nonrandomized Single-arm Prospective Clinical Trial

Abstract Background: Respiratory allergies are a major global health concern, mainly including allergic bronchial asthma and allergic rhinitis. Childhood asthma affects about 7% of Indian children and is a leading cause of morbidity, while allergic rhinitis prevalence is 11.3% in children aged 6–7 years. Respiratory allergic disorders can be correlated with Vatika Pratisyaya and Tamaka Shavasa in Ayurveda. Ayurveda introduces the concept of Vyadhikshamatava (immunomodulation) and formulations to combat these conditions. Aim and Objectives: The present clinical trial was conducted to evaluate Dashmoola Katutrayadi Syrup’s potential immunomodulatory activity for managing pediatric respiratory disorders. Methodology: An open-label non-randomized, single-arm prospective clinical trial has been designed. A total of 30 patients with respiratory allergic disorders were enrolled for the study from the department (outpatient department) of Kaumarbhritya ( Balroga ) at NIA Jaipur, screened using a preassessment questionnaire containing 14 symptom-based questions. A score of 7 or more out of the first 10 questions indicated bronchial asthma (allergic), while a positive response to at least one of the next three suggested nasal allergy. The remaining four questions assessed the severity of previous episodes and any treatment history. Participants aged 6–12 years, of either sex, were included as per protocol. The participants were in a single group that received medication. The active treatment duration was 2 months, followed by a 1-month postintervention follow-up period. Result: Following the clinical trial, clinical assessments showed marked improvement in symptoms and investigative parameters with sustained long-term relief on follow-up, supporting the formulation’s therapeutic value in respiratory allergy management. Conclusion: Most of the pediatric infections can be prevented with medications that enhance nonspecific immunity. Ayurveda offers a comprehensive approach to manage respiratory allergic disorders. Dashmoola Katutaryadi syrup, a multimodal formulation, demonstrated significant efficacy in reducing the morbidity associated with respiratory allergic disorders.