Publication:

Evaluation of Panchkol Churna against lifestyle modification in cardiovascular risk management: a protocol for an open-label, randomized comparative clinical trial

Background Cardiovascular disease (CVD) remains the leading cause of global mortality, with significant variations in prevalence and mortality rates. Ayurveda advocates the Rasadhatu dushti (RDD) as a component in the development of Hrid rogas. Also, Hridaya has been described as the root (Moola) of Rasavaha srotas, therefore any kind of vitiation in Rasadhatu is liable to affect the heart causing pathologies. The study aims to provide evidence for the role of RDD in CVD and explore integrative approaches to reduce the risk of CVDs.

Methods This is a study with two phases including a screening and recruitment phase to assess prevalence of RDD with sample size of 390 participants and a clinical trial phase with two groups (A & B) with 30 participants in each group. The participants in group-A will receive Panchkol churna in dose of 3gm for 30 days with Luke warm before meal and group-B will receive life style modification for 30 days. The primary outcome is the assessment of prevalence of RDD in participants at risk of CVDs. The secondary outcome is the changes in Gene expression (Apo-E and IL-6), Framingham risk score (Appendix 2), RAS-RCVD (Appendix 1) score and lipid profile.

Conclusions This protocol outlines a mixed-method study to investigate the prevalence of RDD in participants at risk of CVD and evaluate the comparative efficacy of Panchkol Churna against lifestyle modification (LSM) as risk reduction measures. The study integrates Ayurvedic concepts with modern clinical markers, such as inflammatory markers (IL-6) and gene expression (Apo-E). Trail Registration: Clinical Trial Registry of India (CTRI/2023/05/053143).