Effectiveness of integrating an Ayurvedic protocol to lifestyle modifications in reducing cardiovascular disease risk: A hospital-based randomized trial

Abstract BACKGROUND: Cardiovascular disease (CVD) is the major non-communicable disease of the twenty-first century, with a rising disease burden affecting all countries across the globe. CVD being a lifestyle disorder, Ayurveda might offer potential benefits. The objective of the study was to evaluate the preventive benefit of a concept-driven Ayurvedic protocol, supplemented with lifestyle modifications, in adults at risk for CVD. MATERIALS AND METHODS: The open-labeled parallel randomized controlled trial was conducted on 200 (100 per group) adults aged above 35 years with undiagnosed coronary artery disease. They were screened for risk assessment using the WHO/ISH risk prediction chart from the outpatient department of Government Ayurveda College, Tripunithura, Kerala. The participants were randomly allocated in a 1:1 ratio to two groups. The trial group received a 49-day-long Ayurvedic protocol and lifestyle interventions (WHO-recommended diet, physical activity, tobacco cessation, and exercise). The control group received only lifestyle interventions for the same period. The protocol was formulated through the consensus of academic experts and clinicians. The primary outcome was the QRISK®3 CVD risk score, and the secondary outcomes included the proportion of modifiable risk measures. Changes in CVD risk from the baseline value after the 49 th day, 3 months, and 6 months were compared using intention-to-treat analysis and analyzed using repeated-measures ANOVA. RESULTS: The data of 127 male (n 1= 64%, n 2 = 63%) and 73 females (n 1 = 36%, n 2 = 37%) were analyzed. The baseline CVD risk score and other variables, except systolic BP, were not significantly different between the two groups. The reduction in Qrisk®3 score over the four assessment points between the groups was statistically significant ( P < 0.001). A moderate effect size of CVD risk reduction between groups across time was observed, as inferred from the partial eta squared value, which was 0.083 (95% confidence interval 0.03–0.14). There was a 22.1% reduction in the mean CVD score in the trial group, as against 7.1% in the control group at the end of 6 months. Among the modifiable risk variables, there was a reduction of 12.7 mm of Hg in the mean systolic BP (9.4% reduction) and a 10.1 mg/dL reduction in mean total cholesterol (4.9% reduction) in the trial group over 6 months. CONCLUSION: The results indicate the probable benefit of integrating the Ayurvedic protocol over lifestyle modification alone in reducing the risk for CVD. TRIAL CTRI REGISTRATION NUMBER: CTRI/2019/10/021661, dated 16/10/2019. INSTITUTIONAL ETHICS COMMITTEE APPROVAL NO.: 31-01/RN-PJ/IEC/2019 dated 11/04/2019.