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BACKGROUND: Coronary artery disease (CAD) is a substantial contributor to cardiovascular-related morbidity and mortality worldwide. Contemporary medications for CAD management need to be administered for longer periods with limited success. In addition, these medications have limitations owing to their adverse effects on long-term use. Therefore, it is imperative to identify safe, effective, and economical therapeutic options to lower the risk of CAD-related morbidity, mortality, and recurrence. This protocol was developed to assess the clinical efficacy and safety of Ayurveda interventions, Pushkar Guggulu and Haritaki, as an adjunct to standard care in individuals diagnosed with stable CAD compared with standard care alone. METHODS: This randomized controlled trial (RCT) employs a double-blind, randomized controlled design and will be conducted at the Department of Cardiology, Safdarjung Hospital, New Delhi, India. A total of 100 individuals of any gender aged 40-70 years and diagnosed with stable CAD will be enrolled in the study. The participants will be randomly assigned in a 1:1 ratio to receive either Ayurveda interventions (Pushkar Guggulu capsules 1 gram, and Haritaki capsules 500 mg twice daily after meals) or the matching placebo of both the aforementioned Ayurveda interventions for 180 days. The conventional standard care per the current American College of Cardiology/American Heart Association guidelines for CAD management will be provided in both groups. The primary outcome is the change in the Seattle Angina Questionnaire (SAQ) score from baseline. The secondary outcome measures include the change in the grade of the Canadian Cardiovascular Society grading scale of angina pectoris; the change in the grade of the exercise stress test from baseline; the change in lipid profile, IL-6, and serum pro-BNP levels from baseline; the change in the need for standard care medications for CAD from baseline; and the change in health-related QoL (assessed by the SF-12 questionnaire). Safety will be evaluated by recording the incidence of adverse events and changes in laboratory safety parameters (CBC, LFT, KFT) from baseline. DISCUSSION: The outcomes of this RCT can be utilized to develop a strategy to integrate Ayurveda interventions with conventional standard management to achieve a better prognosis in CAD patients. TRIAL REGISTRATION: The study is prospectively registered with the Clinical Trial Registry of India (CTRI/2024/02/062553 dated February 12, 2024).
Sharma et al. (Sat,) studied this question.