Safety and efficacy of Ayurveda compound formulations (Kantakaryavaleha and Eladi gutika) in the management of mild stable bronchial asthma (Tamaka shwasa) – A prospective, open-label, multicentric clinical trial

Background: Bronchial Asthma (BA) is a major health concern that interferes with the quality of life. Better health-care strategies based on an integrative approach are still needed for the management of BA. In light of this, the scope of complementary and traditional medicine therapies should be explored. Objectives: The objectives of this study were to determine the efficacy and safety of Ayurveda polyherbal formulations (Kantakaryavaleha and Eladi gutika) in mild, stable BA. Materials and Methods: The study design was a prospective, open-label, multicentric clinical trial. Overall, 83 diagnosed cases of mild stable BA, 18–60 years of age belonging to both genders, were analyzed based on the inclusion criteria. Ayurveda compounds Eladi gutika (1 g thrice daily) and Kantakaryavaleha (10 g twice daily) with equal amounts of warm water were administered for 84 days. The primary outcomes were measured by assessing the change in the Asthma Control Questionnaire (ACQ) and the frequency of need for control medication before and after the trial interventions. The secondary outcomes were measured by comparing the changes in clinical features, Forced Expiratory Volume 1 s (FEV1), biomarkers such as serum C-reactive protein, IgE, and other laboratory parameters, and any adverse events. Results: A statistically significant (P < 0.001) improvement in ACQ score was observed from 1.61 (0.45) to 0.61 (0.60) and FEV1 from 0.86 (0.05) to 0.93 (0.09) after 84 days of the trial period. Both interventions were found useful in managing the clinical features and biomarkers; no rescue medication was needed, and no clinically significant adverse events were observed during the trial and follow-up period. Conclusions: Kantakaryavaleha and Eladi gutika are remarkably useful and safe in managing mild, stable BA without any rescue and control medication. Further, a double-blind, randomized controlled trial may be planned with a more extended follow-up period to aid the present findings.