Clinical Efficacy And Immunomodulatory Effect Of Bal-Rasayana® Syrup In Pediatric Allergic Rhinitis: An Open-Label Prospective Study

Abstract

Background: Allergic rhinitis (AR) is one of the most common chronic respiratory disorders in children, often associated with asthma and recurrent morbidity. Conventional management with antihistamines is frequently limited by adverse effects, highlighting the need for safe, long-term, immune-modulating therapies. In Ayurveda, AR resembles Vataja Pratishyaya, which arises from Kapha-Vata dosha imbalance and Ama accumulation in the Pranavaha Srotas. Objective: To evaluate the clinical efficacy, safety, and immunomodulatory effects of Bal-Rasayana® syrup, a polyherbal formulation, in children with allergic rhinitis.

Methods: An open-label, non-comparative, prospective clinical trial was conducted in the OPD of Balroga, Bharati Vidyapeeth Ayurved Hospital, Pune. Sixty children aged 3–16 years with recurrent AR were enrolled. Participants received Bal-Rasayana® syrup at a dose of Age (years) × 4 ml twice daily for 90 days, with follow-ups on Day 30, 60, 90, and post-treatment review on Day 120. Subjective symptoms (sneezing, rhinorrhea, nasal obstruction, nasal itching, epiphora) were assessed using clinical scoring, while objective parameters included Absolute Eosinophil Count (AEC) and Serum IgE. Statistical analysis was performed using Wilcoxon Signed Rank Test for subjective parameters and paired t-test for objective parameters, with significance set at p < 0.05.

Results: Significant improvement was observed in all subjective symptoms: sneezing (81.94%), rhinorrhea (78.74%), nasal obstruction (64.15%), nasal itching (68.66%), and epiphora (85.30%) (p < 0.001). Objective parameters also showed marked improvement: AEC decreased by 64.77% and Serum IgE by 78.65% (p < 0.001). Overall, 44.4% of children achieved moderate improvement (50–75% relief) and 36.5% achieved excellent improvement (75–100% relief). No significant adverse effects were reported.

Conclusion: Bal-Rasayana® syrup is a safe, effective, and child-friendly polyherbal intervention for allergic rhinitis, providing significant symptomatic relief and immunomodulatory benefits. The formulation addresses the underlying Ayurvedic pathophysiology by restoring Agni, clearing Ama, pacifying Kapha-Vata dosha, and strengthening the Pranavaha Srotas. These findings support its use as a holistic alternative or adjunct to conventional therapy in pediatric AR.