Preclinical and Clinical Study To Evaluate The Safety and Efficacy of Bootha Chakkara Podi for Sooli Kanam (Childhood bronchial asthma) in children (6 -12 years of age) attending OPD of National Institute Of Siddha - An Open Clinical Trial

This study is a non-randomised, open-label clinical trial conducted at the Outpatient Department of the National Institute of Siddha to evaluate the efficacy and safety of Siddha formulations in the management of Sooli Kanam (childhood bronchial asthma). A total of 148 children aged 6–12 years diagnosed with Sooli Kanam are enrolled in the study. Participants are allocated into two treatment groups, with 74 participants receiving Bootha Chakkara Podi and 74 participants receiving Thaalisaathi Chooranam .The study drugs are administered orally for a period of 48 days twice a day. Participants are followed throughout the treatment period for assessment of efficacy and safety.Clinical symptoms are assessed  on Days 8, 15, 22, 29, 36, and 49. Pulmonary function is evaluated by spirometry, measuring Forced Expiratory Volume in one second (FEV1) and other pulmonary function parameters at baseline Day 1, Day 22, and Day 49. All observations are documented in the Case Report Form .The primary outcome measure is Percentage reduction  in FEV1 from baseline to the end of treatment. Secondary outcome measures is to compare the efficacy of Bootha chakkara podi and Thaalisaathi chooranam in improving clinical symptoms.Percentage reduction in the symptoms of  Childhood Bronchial Asthma  through Paediatric Asthma Severity Score(PASS) from baseline to the end of the treatment. The study aims to generate clinical evidence on the effectiveness and safety of Siddha medicines in childhood bronchial asthma.