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

Palak R. Barvadia; Mandip Goyal

doi:10.18203/2349-3259.ijct20263762

Authors

Palak R. Barvadia Department of Kayachikitsa, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India
Mandip Goyal Department of Kayachikitsa, Institute of Teaching and Research in Ayurveda, Jamnagar, Gujarat, India

DOI:

https://doi.org/10.18203/2349-3259.ijct20263762

Keywords:

Arogyavardhini rasa, Hridroga, Left ventricular ejection fraction, Left ventricular remodeling, Nagabala-Arjunadi Yoga, N-terminal pro-B-type natriuretic peptide, Post-myocardial infarction

Abstract

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.

References

Jayaraj JC, Davatyan K, Subramanian SS, Priya JPamukçu B. Epidemiology of Myocardial Infarction Myocardial Infarction. Rijeka IntechOpen. 2018.

Loscalzo J. Ischemic heart disease. Harrison’s Principles of Internal Medicine. 20th ed. McGraw-Hill. 2018

Sharma J. Chakradatta by Chakrapani Datta, Khemraja Shrikrishnadasa Prakashan, Bombay, 4th edition, Hridrogadhikara, verse 15/16. 2018;160.

Vidhyanath R, Nishteswar K. Sahastrayoga, chowkhamba sanskrit series office, Varanasi, 2nd edition kashaya prakarana, vatahara Kashaya. 2008;59.3:46.

Bhatt AS, Ambrosy AP, Velazquez EJ. Adverse Remodelling and Reverse Remodelling After Myocardial Infarction. Curr Cardiol Rep. 2017;19(8):71.

Kosaraju A, Goyal A, Grigorova Y, Kosaraju A, Goyal A, Grigorova Y. Left Ventricular Ejection Fraction. In: StatPearls. Treasure Island (FL): StatPearls Publishing. StatPearls Treasure Isl. 2022.

Kong WH. Llewellyn-Thomas H, Naylor CD. The internal logic of the Canadian Cardiovascular Society scale for grading angina pectoris: a first appraisal. Can J Cardiol. 1992;8(9):947-53.

Raphael C, Briscoe C, Davies J, Ian Whinnett Z, Manisty C, Sutton R, et al. Limitations of the New York Heart Association functional classification system and self-reported walking distances in chronic heart failure. Heart. 2007;93(4):476-82.

De Vecchis R, Ariano C. The MacNew Questionnaire: A Tool to Predict Unplanned Rehospitalization After Coronary Revascularization. Int J Cardiov Sci. 2016;29(4):303-13.

Byrne RA, Rossello X, Coughlan JJ, Barbato E, Berry C, Chieffo A, et al. 2023 ESC Guidelines for the management of acute coronary syndromes: Developed by the task force on the management of acute coronary syndromes of the European Society of Cardiology (ESC). European Heart J. 2023;44(38):3720-826.

Mishra SN. Bhaishajya Ratnavali of Govinda Das Sen with Siddhi Prada Hindi commentary, part 2, Chaukhamba Ayur Vigyan series, Varanasi, Prakaran 33, Hridrogadhikara, verse 76-81. 2018;673-4.