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
|
|
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
|
|
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
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | 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 | 2 | Comparator Arm (Non Ayurveda) | | - | Homeopathy Medicines | Aurum Met in recommended doses designed by Homeopathic Materia medica and Rappo Tary | 3 | Comparator Arm (Non Ayurveda) | | - | Behavioural Therapy | Classical 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. |