Vol. 2, Issue 2, Part A (2025)

Background: Recurrent cough and wheeze in childhood are common, impair quality of life and school attendance, and often require long-term pharmacotherapy. Classical Ayurvedic formulations described for Kasa and Tamaka Shwasa are widely used in practice, but comparative evidence in pediatric populations is limited.

Objective: To compare the efficacy and safety of Vasa Avaleha, a Kantakari-dominant Avaleha and a Vasa-Kantakari combination in the management of recurrent pediatric Kasa and Shwasa (cough and wheeze).

Methods: This prospective, randomized, open-label, three-arm, parallel-group clinical study was conducted in the Kaumarbhritya outpatient department of a tertiary-care Ayurvedic teaching hospital. Children aged 3-12 years with ≥3 episodes of cough with wheeze/breathlessness in the preceding 12 months and a clinical diagnosis compatible with recurrent Kasa and Shwasa were randomized (1:1:1) to: Group A (Vasa Avaleha), Group B (Kantakari-dominant Avaleha) or Group C (Vasa-Kantakari combination Avaleha/granules). Treatment duration was 8 weeks with 12 weeks of post-treatment follow-up. Primary outcomes were change in episode frequency over 12 weeks, composite symptom severity score and days of rescue bronchodilator use. Secondary outcomes included changes in FEV₁ and PEFR, recurrence-free interval, school absenteeism, caregiver global assessment and safety parameters. Analyses were performed on an intention-to-treat basis using appropriate parametric and non-parametric tests.

Results: Of 118 screened children, 90 were randomized (30 per group); 86 completed treatment and 82 completed follow-up. Baseline characteristics were comparable across groups. All three regimens produced significant within-group reductions in episode frequency, symptom scores and rescue bronchodilator use (p<0.001) and significant improvements in FEV₁ and PEFR. At 8 weeks, mean episode frequency decreased from 5.3±1.2 to 2.3±1.0 in Group A, 5.2±1.3 to 2.6±1.1 in Group B and 5.4±1.1 to 1.6±0.9 in Group C, with between-group differences favouring Group C (p<0.001). The Vasa-Kantakari combination also showed the greatest gains in FEV₁ and PEFR and the longest recurrence-free interval over 20 weeks. School absenteeism declined and caregiver-rated “much/very much improved” status was highest in Group C. Adverse events were mild, predominantly transient gastrointestinal symptoms, with no serious events or clinically relevant laboratory abnormalities.

Conclusion: Vasa Avaleha, Kantakari-dominant Avaleha and a Vasa-Kantakari combination are effective and well tolerated as integrative therapies for recurrent pediatric Kasa and Shwasa, with the Vasa-Kantakari combination providing superior and more sustained improvement in symptoms, lung function and functional outcomes. Incorporation of such classical formulations, alongside individualized diet-lifestyle measures and rational conventional care, may offer a useful, child-friendly strategy for reducing the burden of recurrent cough and wheeze in children.