FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/089282 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 21/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Ayurveda Panchakarma therapy and Homeopathic medicines for children with Autism 
Scientific Title of Study   A comparative study on the efficacy of Ayurveda and Homeopathy in treating Autism Spectrum Disorder: An evidence-based approach.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Swapnil C Raskar 
Designation  Professor  
Affiliation  Parul Institute of Ayurved 
Address  Room No 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University At post Limda Tehsil Waghodia

Vadodara
GUJARAT
391760
India 
Phone  09726587013  
Fax    
Email  neonatecare2024@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Swapnil C Raskar 
Designation  Professor  
Affiliation  Parul Institute of Ayurved 
Address  Room No 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University At post Limda Tehsil Waghodia


GUJARAT
391760
India 
Phone  09726587013  
Fax    
Email  neonatecare2024@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Swapnil C Raskar 
Designation  Professor  
Affiliation  Parul Institute of Ayurved 
Address  Room No 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University At post Limda Tehsil Waghodia


GUJARAT
391760
India 
Phone  09726587013  
Fax    
Email  neonatecare2024@gmail.com  
 
Source of Monetary or Material Support  
Parul University At Post Limda Tehsil Waghodia Vadodara Gujarat 391760 
 
Primary Sponsor  
Name  Parul University 
Address  Room No 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University At post Limda Tehsil Waghodia Dist Vadodara Gujarat Bharat 391760 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Swapnil C Raskar  Parul Ayurveda Hospital  OPD no 103 Parul Ayurveda Hospital Parul University At Post Limda Tehsil Waghodia Dist Vadodara Gujarat 391760
Vadodara
GUJARAT 
9726587013

neonatecare2024@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Parul Institute of Ayurved Parul University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F988||Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-Abhyanga and Basti (Procedure Reference: Charaka Samhita, Procedure details: Application of Bala Taila for Abhyanga and Bilvadi Taila for Basti [Dosage selected as per age])
(1) Medicine Name: Aurokid Plus , Reference: Anubhuta, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 250(mg), Frequency: tds, Duration: 90 Days
2Comparator Arm (Non Ayurveda)-Homeopathy MedicinesAurum Met in recommended doses designed by Homeopathic Materia medica and Rappo Tary
3Comparator Arm (Non Ayurveda)-Behavioural TherapyClassical Neurobehavior therapy for ASD recommended by pediatrician and pediatric neurophysician
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  1 Children with Diagnosed cases of ASD
2 Children with ASD with parents consent to willing to participate in clinical trial
3 Children with score more than 100 on ISAA (Indian Scale for Autism Assessment)  
 
ExclusionCriteria 
Details  1 Children age less than 3 years and above 16 years
2 Children with ASD and their parents not willing to participate or giving consent
3 Children with score less than 100 on ISAA (Indian Scale for Autism Assessment)
4 Child with ASD with other neurobehavior diseases, epilepsy and progressive neurological disorders 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1 Improvement in ISAA score
2 Improvement in Cognition and concentration  
at the time of enrollment
30 days
60 days
90 days
120 days  
 
Secondary Outcome  
Outcome  TimePoints 
1 Improvement in social communication
2 Improvement in speech 
at the time of enrollment
30 days
60 days
90 days
120 days 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   10/06/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   ASD is Neurobehavior disease affecting the social behaviour and learning skill of child. 

Background & Rationale:

 

Autism Spectrum Disorder (ASD) in children is a neurodevelopmental condition marked by challenges in communication, behavior, and sensory integration. Conventional treatments are often limited to behavioral therapies and symptomatic pharmacological interventions, with varying efficacy and potential side effects. Integrative medical approaches—particularly Ayurveda and Homeopathy—offer promising adjuncts through individualized, holistic care.

 

Ayurveda Perspective:

 

Ayurveda conceptualizes ASD in terms of Unmada or Vata-predominant neurodevelopmental imbalances, often linked to disturbances in Agni (digestive fire), Ojas (vital essence), and the nervous system (Majja Dhatu). Ayurvedic treatment protocols focus on restoring systemic equilibrium using medhya rasayana (nootropic herbs), dietary corrections, and Panchakarma procedures, thereby aiming to improve cognitive function, social behavior, and physiological balance in children with ASD.

 

Homeopathy Perspective:

 

Homeopathy, based on the principle of individualized remedy selection, has been observed to modulate behavioral and emotional dysregulation in ASD. It addresses the child’s unique symptom profile—emotional, physical, and developmental—to stimulate the body’s innate healing response. This aligns with non-invasive, child-friendly modalities that are crucial in pediatric care.

 

Objective:

 

This trial aims to evaluate the clinical efficacy and safety of Ayurveda and Homeopathy interventions in the management of pediatric ASD symptoms. It explores the potential synergistic benefits of integrative, personalized treatments in enhancing quality of life and developmental outcomes.


 
Close