A SINGLE-CENTRIC, SINGLE-ARM PILOT STUDY TO EVALUATE THE SAFETY AND EFFECTIVENESS OF SWASA KUDORI CHOORANAM (SKC) IN THE MANAGEMENT OF SWASA KAASAM (BRONCHIAL ASTHMA) – A STUDY PROTOCOL

Background: Cuvācakācam (SwasaKaasam) is one of the twelve types of Kācam in Siddha System of Medicine and is clinically correlated with Bronchial Asthma. Asthma is a Non-Communicable Disease that affects global health invariably by affecting all age groups with 5^th global rank in terms of Daly’s. According to GBD, 13.09% of the population in India suffered from asthma and the prevalence in Puducherry was 8.6%. The present conventional anti-asthmatic drugs have several side effects, and the patient’s QoL is also compromised. Thus, it is imperative to explore alternative or complementary therapeutic techniques in view of adverse effects, out-of-pocket expenses, and patient compliance. Aim: The present study aims to evaluate the safety and effectiveness of Swasa Kudori Chooranam in Bronchial Asthma patients. Methods: This is a single-arm pilot study of 37 participants with a known history of Cuvācakācam (Bronchial asthma). Trial drug will be advocated for a period of 30 days as per the prescribed dose followed by baseline investigations. The outcome assessments included PFT, ACT, mMRC Dyspnoea Scale, AQLQ(S); safety parameters such as LFT, RFT, CRP, AEC and Urine routine will be done on D0, D15, D30 and D121. The Reduction in frequency of allopathic drug usage throughout the study period will also be assessed. Discussion: This trial is an attempt to explore the safety and effectiveness of SKC for bronchial asthma disease management and quality of life. Trial Registration: The trial was prospectively registered in the Clinical Trial Registry of India (CTRI) – CTRI/2024/03/064944.