A study protocol for assessing the efficacy of Nagabala-Arjunadi Yoga and Arogyavardhini Rasa in the management of post-myocardial infarction as an add-on to the standard care: a standard controlled clinical trial

Background: Myocardial infarction (MI) is a major cause of cardiovascular morbidity and mortality. Despite advances in reperfusion and standard pharmacological management, patients may develop left ventricular dysfunction, adverse cardiac remodelling, recurrent ischemic symptoms, reduced functional capacity, and impaired quality of life. Nagabala-Arjunadi Yoga has shown beneficial effects on cardiac symptoms, left ventricular ejection fraction (LVEF), and quality of life in previous study. Arogyavardhini Rasa, with its Hridya (Cardioprotective), Lekhana (Scraping action), and Medohara (Hypolipidemic) properties, may provide additional cardiovascular benefits. However, evidence regarding their combined efficacy in post-MI management remains limited. Objectives were to evaluate the efficacy of Nagabala-Arjunadi Yoga and Arogyavardhini Rasa as add-on to standard care in post-MI patients. Methods: This prospective, open-label, randomized, standard-controlled clinical trial will enrol 106 post-MI patients. Participants will be allocated to receive either Nagabala-Arjunadi Yoga and Arogyavardhini Rasa alongside standard care or standard care alone for 12 weeks. Primary outcomes will include changes in LVEF, left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), N-terminal pro-B-type natriuretic peptide (NT-proBNP), angina severity, fatigue, dyspnoea, and functional capacity. Health-related quality of life (HRQoL) will be assessed using the MacNew questionnaire as a secondary outcome. Assessments will be performed at baseline and post-treatment. Appropriate parametric and non-parametric statistical tests will be applied, with p<0.05 considered statistically significant. Conclusions: The study will evaluate whether these Ayurvedic formulations, as add-on to standard care, improve cardiac function, remodelling parameters, NT-proBNP levels, ischemic symptoms, functional capacity, and quality of life in post-MI patients. Trial Registration: The trial is registered with Clinical Trial Registry of India (CTRI). CTRI/2026/07/114947.