Vitality and metabolic responses to integrated naturopathy and yogic interventions among metabolic syndrome - A protocol for randomized controlled trial

Background: Metabolic Syndrome (MetS) refers to a collection of interrelated physiological, biochemical, clinical, and metabolic variables that significantly raise the risk of type 2 diabetes, cardiovascular disease, and all-cause mortality. This trial aims to assess the effect of Naturopathy and Yogic Interventions on Vitality and Metabolic responses among patients with MetS. Method: This trial is a single Centre Randomized Controlled Trial (RCT) and will be conducted at Nature Cure and Yoga Centre in the Southern part of India. Enrolled subjects with MetS, who fulfilled National Cholesterol Education Program Adult Treatment Panel III [NCEP ATP III Criteria], will be randomly allocated at a 1:1 ratio into Intervention and control groups. The Intervention group will receive Intensive Naturopathy and Yoga Intervention whereas the control group will receive a lifestyle advice during the initial consultation. The primary outcome will be measured by Heart Rate Variability (HRV), Blood Pressure Measurement, Biochemical Analysis, Anthropometric Measurement, Vitality Questionnaire, and Framingham Risk Score (FRS) which will be performed at the baseline and after 10 days of intervention and follow up will be taken at the 60th day. Discussion: A larger clinical trial will be possible as a result of this study's contribution to the understanding of the effectiveness of Yogic Interventions and Integrated Naturopathy for MetS and associated risk factors.