Accepted for/Published in: JMIR Research Protocols
Date Submitted: Oct 5, 2024
Date Accepted: Jul 30, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Impact of intra nasal administration of Ayurveda Medicine in apparently Healthy individuals on neuro-physiological variables and functional connectivity in Brain-Study protocol of an Exploratory Randomized Controlled Trial using f-MRI
ABSTRACT
Background:
Nasya karma, Ayurveda nasal drug delivery system, is considered as one of the potent therapeutic modalities among Panchakarma. The uniqueness of the procedure lies in the fact that nasal drug delivery can bypass normal liver metabolism and BBB (Blood Brain Barrier), opening up a faster drug-delivery pathway. Available studies on ‘Nasya’ focus mainly on the efficacy of the same. 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 MRI.
Objective:
The study aims to map the neuro-physiological response of brain to Nasya using BOLD functional MRI in both rest and task phases and to assess its impact on quality of life, cognition, sleep, and psychological well-being in healthy volunteers.
Methods:
60 healthy volunteers, in the age group of 20-40 years fulfilling the selection criteria will be recruited for this RCT from National Ayurveda Institute of Panchakarma, Kerala, India and randomized in 1:1 ratio to either the intervention group, n=30 (Group I receiving Nasya with Anu Taila for a period of 14 days) or the Control Group, n=30 (Group II), not receiving any intervention. The participants will undergo task based and resting f-MRI on day 1(twice on day 1, before administration and 15 minutes after Nasya for participants in Group I) and day 14 to map the neuro-physiological response of Nasya on brain. A comprehensive neuroimaging protocol using structural and functional magnetic resonance imaging will be employed in the study.Effect of Nasyain sleep, psychological domain, cognitive function, quality of life domain will be assessed on 1st day and 30th day in both the groups.
Results:
This study will investigate the neurophysiological mechanisms of Nasya by examining clinical, neuropsychological, and neuroimaging variables to identify associated neural patterns to develop therapeutic protocols for manu diseases. The findings will also provide evidence for future research, supporting the use of Nasya as a practical and noninvasive therapeutic modality for treating cerebrovascular, behavioral, and neurological disorders, as indicated in Ayurveda.
Conclusions:
The study will propel innovative research focusing on the neural mechanisms responsible for the delivery of central nervous system therapeutics to the brain and thereby bypassing BBB and generating favorable outcomes in CNS diseases Clinical Trial: Trial has been registered prospectively in Clinical Trial Registry of India with registration number CTRI/2023/06/054219 dated 20.06.2023
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