Impact of Intranasal Administration of Ayurveda Medicine in Apparently Healthy Individuals on Neurophysiological Variables and Functional Connectivity Using Functional Magnetic Resonance Imaging: Protocol for an Exploratory Randomized Controlled Trial.

backgroundNasyakarma, an Ayurveda nasal drug delivery system, is considered a potent therapeutic modality in panchakarma treatment. Uniquely, nasal drug delivery can bypass liver metabolism and the blood-brain barrier for faster drug delivery. Available studies on nasya karma focus mainly on its efficacy. This pioneering study aims to explore the mechanisms of nasya karma on brain function and neurophysiology, investigating its potential to modulate activity in specific brain regions and affect the functional connectivity between these regions using functional magnetic resonance imaging (fMRI).

objectiveThe study aims to map the neurophysiological response of the brain to nasya karma using blood oxygen level-dependent fMRI in both rest and task phases and assess the impact of nasya karma on quality of life, cognition, sleep, and psychological well-being in healthy volunteers.

methodsA total of 60 healthy volunteers in the age group of 20 to 40 years who fulfill the selection criteria will be recruited for this randomized controlled trial at the National Ayurveda Institute for Panchakarma, Cheruthuruthy, Kerala, India, and randomized in a 1:1 ratio to either the intervention group (n=30; group 1, receiving nasya karma with anu taila, an oil-based formulation manufactured using a paste and decoction of herbal medicines with oils as the base material, for a period of 14 days) or the control group (n=30; group 2, not receiving any intervention). The participants will undergo task-based and resting fMRI on day 1 (twice on day 1 before administration and 15 minutes after nasya karma for participants in group 1) and day 14 to map the neurophysiological response to nasya karma of the brain. A comprehensive neuroimaging protocol using structural magnetic resonance imaging and fMRI will be used in the study. The effect of nasya karma on sleep, psychological well-being, cognition, and quality of life will be assessed on the 1st and 30th days in both groups.

resultsAfter the data collection process of this randomized controlled trial is completed, the study will go into the analysis stage, in which the collected data will be subjected to robust statistical analysis. The final results of the study are expected to be published in 2026.

conclusionsThis study will investigate the neurophysiological mechanisms of nasya karma by examining clinical, neuropsychological, and neuroimaging variables to identify associated neural patterns to develop therapeutic protocols for many diseases. The findings will also provide evidence for future research supporting the use of nasya karma as a practical and noninvasive therapeutic modality for treating cerebrovascular, behavioral, and neurological disorders as indicated in Ayurveda. The study will propel innovative research focusing on the neural mechanisms responsible for the delivery of central nervous system therapeutics to the brain, thereby bypassing the blood-brain barrier and yielding favorable outcomes in central nervous system diseases.

trial registrationClinical Trials Registry - India CTRI/2023/06/054219; hhttps://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=ODQ1OTU=&Enc=&userName=. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/67132.