1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [shrutikreddy08@gmail.com].
   


6. For how long will this data be available start date provided 05-06-2025 and end date provided 05-06-2030?
   Response - Beginning 3 months and ending 5 years following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Childhood is the period of physical, cognitive and social development that begins at birth and continues through early adulthood. Childhood is a time of imagination and creativity. Sensory experiences in childhood play a vital role in developing neural connection and pathways that are essential for learning, memory and overall cognitive development.

Autism comprises of multiple deficits that are yet to be understood, one of them being the sensory difficulties which are collectively termed as Sensory Processing Disorders (SPD). Rate of Sensory Processing Dysfunction may be as high as 90% in individual with autism. The abnormal sensory reactivity is associated with severity of autism, poor functional outcomes and behavioural difficulties including anxiety disorders across the lifespan. Early characterization of sensory abnormalities would be of tremendous value for guiding therapeutic interventions.

But in practice it is observed that the prime focus of parents and medical fraternity in the management of autism lies in the initiation of speech and correction of social behaviour, Sensory Dysfunction being paid less attention most of the times. Sensory Integration Therapy is a gold standard approach aimed at improving Sensory Processing in such children. Several studies are conducted in Ayurveda on Autism, but they lack a specific approach to sensory dysfunction.

SPD can be considered as Indriyapradoshaja Vikaras mentioned in Ayurveda where there is Upatapa (Vaikalya - Partial loss of function or altered function) and Upaghata (Nasha- Total loss of Functions, may be Permanent or Temporary) of Indriyas that leads to the

dysfunction of sensory pathways. 

(3) (4)

Indriyapradoshaja Vikaras may be treated on lines of Shiromarma Chikitsa as well with Rasayana Dravyas which facilitate the restoration of sensory functions. Shiromarma Chikitsa includes Nasya, Abhyanga, Snehapana etc. There are several Rasayana Yogas mentioned in classics which are said to be Buddheendriyabalaprada (Strengthening the sensory organs), few of them being Amalaki Avaleha, Amalaki Churna, Amalaki Ghrita, Panchama Haritaki Yoga, And Panchendriyavardhana Ghrita. These Yogas may be administered in the form of Nasya or orally as indicated which can correct the deranged function of Indriyas and their entire pathway. Thus, considering the fact that the sensory abnormalities in Autism and its remedies are unexplored through Ayurveda and a specialized approach to SPD is the need of the day, two different approaches are planned to be studied in SPD.

Thus, the current study is aimed at finding the efficacy of Panchendriyavardhana Ghrita Pratimarsha Nasya and Amalaki Avaleha orally in Sensory Processing Disorders, with special reference to Indriyapradoshaja Vikaras in children with Autism.