Ayurveda therapeutic regimen as on Add-on to optimized conventional management of Parkinson’s disease: An RCT for assessment of Clinical Cortical excitability Neuroimmune and Autonomic function parameters

This study is a randomized single-blind, parallel-group trial comparing the safety and efficacy of Add-on Ayurveda intervention (Yoga Basti with Erandamoola Kashaya and Bala Taila for 8 days, Mashabaladi Kvatha, Kalyanaka Gritha for 47 days, and Chitrakadi vati for 5 days every two months for a duration of 6 Months) and Conventional treatment (Levodopa and carbidopa/ Pramipexole/ Ropinirole/ Amantadine/ Entacapone, Rasagiline/ Selegiline) daily for six months in 160 subjects (80 in each group) with Parkinson’s Disease (PD) that will be conducted at National Institute of Mental health and Neurosciences (NIMHANS) Bengaluru. The primary outcome measure will be Changes in the sum of the MDS-UPDRS score at six months. The secondary outcome measures are - Changes in cortical excitability through Single and paired-pulse Transcranial magnetic stimulation measures, Heart Rate Variability, Pulmonary function tests, Th1/Th2/Th17/T regulatory cell population, plasma levels of pro-inflammatory cytokines, Telomere Length, Unified Dyskinesia Rating Scale (UDysRS), Montreal Cognitive Assessment (MoCA), Mini BESTest (Balance Evaluation Systems Test), Gait assessed through 6-minute walk test and gait speed (10-meter walk test), Epworth Sleepiness Scale (ESS) and Safety of Ayurveda interventions at six months