Effect of Add-on Integrated Yoga and Ayurveda Management on Clinical and Neurobiological Parameters in Multiple Sclerosis: A Randomized Controlled Trial Protocol

Abstract

Background Multiple sclerosis (MS) is a progressive autoimmune neurodegenerative disorder characterized by inflammation, demyelination, and axonal damage. Current disease-modifying therapies demonstrate limited efficacy with substantial adverse effects. Ayurveda and yoga have demonstrated disease-modifying potential through anti-inflammatory, immunomodulatory, and neuroprotective mechanisms. Objective This study aims to evaluate the efficacy of a three-month Integrated Yoga and Ayurveda Management (IYAM) program as an adjunct to standard care in MS patients. Primary outcomes include clinical disability (EDSS), functional capacity (MSFC), quality of life (MSQOL-54), cognition (AVLT), and psychological parameters (HARS/HDRS). Secondary outcomes encompass neuroimaging (brain volume, connectivity), immune biomarkers (Th1/Th2/Th17/Treg cells, cytokines, telomere length), autonomic function (HRV), and gut microbiome composition. Methods In this assessor-blind randomized controlled superiority trial, 60 MS patients (McDonald criteria 2017, disease duration <2 years) will be recruited from tertiary care settings after informed consent. Participants will be randomly allocated (1:1) to IYAM (Ayurvedic Rasayanas: Lashuna 16 days, Bala 36 days, Shatavari 36 days and 2 days alotted for sadhyovirechana, plus yoga therapy) or standard care. A computer-generated randomization sequence was created using the REDCap randomization module. Group assignments were concealed until participant enrollment, ensuring allocation concealment, with blinded assessors. Assessments at baseline, 45 days and three months include clinical scales, neuropsychological testing, 3 T MRI, immunophenotyping, and microbiome analysis. Intent-to-treat analysis with mixed repeated measures ANOVA. Expected Outcomes Significant improvements in disability, cognition, and quality of life are anticipated in IYAM group, mediated through neuroinflammatory modulation, enhanced neuroprotection, and favorable gut microbiome alterations. Trial Registration Clinical Trials Registry-India (CTRI/2024/12/078605); date of registration: 26 December 2024; dates of clinical trial: January 2025 to December 2027. Protocol Version Version 1.0, October 2025.