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Journal of Research in Ayurvedic Sciences 2022 January- March ; 6 (1) :2-30
The efficacy and safety of Kantakaryavaleha and Eladi Gutika in the management of mild stable bronchial asthma (Tamaka Shwasa): study protocol for a multicenter, prospective, single-arm, open label, clinical study

Abstract
BACKGROUND: Although Ayurveda medicine is used to manage bronchial asthma, available evidence relating to its efficacy needs to be generated. To scientifically evaluate the efficacy and safety of Ayurveda interventions, Kantakaryavaleha and Eladi Gutika, a multicenter, prospective, single-arm, open-label clinical study on mild stable bronchial asthma (Tamaka Shwasa) will be initiated. MATERIALS AND METHODS: 90 patients (45 in each center) with mild stable bronchial asthma will be enrolled based on inclusion and exclusion criteria. All the patients will be treated with Ayurveda medicines, i.e., Kantakaryavaleha 10?g, orally, twice daily with lukewarm water and tablet Eladi Gutika, 1?g thrice daily, orally. The intervention period will be 12 weeks and each participant will be followed up for 2 more weeks post intervention period. The primary outcomes will be measured assessing the change in the Asthma Control Questionnaire and the frequency of need for control medication before and after the trial intervention. The secondary outcomes will be measured by comparing the changes in clinical signs and symptoms of Tamaka Shwasa as per the Ayurveda classical text, changes in forced expiratory volume (FEV1), and biomarkers such as serum C-reactive protein (CRP), and IgE. TRIAL REGISTRATION: The trial has been registered at the Clinical Trials Registry-India (CTRI); the registration number for this trial is CTRI/2018/06/014425. Keywords: Bronchial asthma, Eladi Gutika, Kantakaryavaleha, Tamaka Shwasa

DHARA ID: D060662


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