Ayurveda therapeutic regimen as an Add-on to optimized conventional management of Parkinson’s disease: Protocol for an exploratory RCT for assessment of Clinical, Cortical excitability, Neuroimmune and Autonomic function parameters (Preprint)

BACKGROUND Parkinson's disease (PD), a progressive neurodegenerative disorder, lacks disease-modifying treatments. Current therapies focus on symptomatic relief, highlighting the need for adjunctive neuroprotective strategies. Ayurveda, a holistic system, shows promise in improving PD clinical outcomes. This randomized, assessor-blinded trial will evaluate the efficacy and safety of integrating Ayurveda with standard PD treatment. OBJECTIVE This assessor-blind randomized controlled study aims to systematically evaluate the efficacy of an add-on Ayurveda therapeutic regimen compared to conventional treatment as usual in improving the clinical outcomes of PD. METHODS Eighty PD patients, diagnosed by UKPDSBB criteria, will be randomized into two groups: Treatment as Usual (TAU) and Add-on Ayurveda. The intervention group will receive Ayurvedic therapy alongside conventional treatment for 180 days, while the control group continues TAU. Assessments will occur at baseline, 60, 120, and 180 days, evaluating motor and non-motor symptoms. Transcranial Magnetic Stimulation (TMS), Heart Rate Variability (HRV), and Pulmonary Function Tests (PFT) will assess cortical excitability, autonomic and pulmonary function respectively. Immunological parameters, including cytokine levels and telomere length, will be analyzed at baseline and 180 days to explore disease-modifying effects. Liver and renal function tests to monitor safety. RESULTS As of August 2025, a total of 259 patients with Parkinson’s disease have been screened for eligibility, of whom 58 participants have been successfully enrolled in the trial. Among these, 33 participants have completed the intervention and follow-up assessments, 14 have discontinued participation, and 11 are currently continuing in the study. Recruitment and follow-up are ongoing, and the trial is scheduled for completion in September 2026. CONCLUSIONS This study aims to address the lack of mechanistic evidence and robust data on Ayurveda in PD. By systematically evaluating clinical efficacy and potential bio-mechanisms, the findings will provide preliminary evidence for Ayurvedic interventions, potentially paving the way for their integration into comprehensive PD management. CLINICALTRIAL Clinical Trial Registry of India - CTRI/2022/01/039803 [Registered on: 28/01/2022].