CTRI/2025/12/099634 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On:
19/12/2025
Post Graduate Thesis
Yes
Type of Trial
Interventional
Type of Study
Ayurveda
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A Study to Assess the Effect of Ayurvedic Treatment and Occupational Therapy in Children with Autism Spectrum Disorde
Scientific Title of Study
EVALUATION OF KUSHTHADI GHRITA ALONGWITH PANCHBHAUTIKA TAILA
PRATIMARSHA NASYA AND OCCUPATIONAL THERAPY IN THE
MANAGEMENT OF AUTISM SPECTRUM DISORDER IN CHILDREN- A RANDOMIZED
CONTROLLED TRIAL
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Amar Marode
Designation
MD Scholar
Affiliation
National Institute of Ayurveda
Address
Department of Kaumarbhritya, National Institute of Ayurveda, Jaipur
Jaipur RAJASTHAN 302002 India
Phone
9067145649
Fax
Email
amarmarode9119@gmail.com
Details of Contact Person Scientific Query
Name
Prof Dr Nisha Kumari Ojha
Designation
HOD, Professor
Affiliation
National Institute of Ayurveda
Address
Department of Kaumarbhritya, National Institute of Ayurveda, Jaipur
Jaipur RAJASTHAN 302002 India
Phone
9468650449
Fax
Email
drnishaojha@gmail.com
Details of Contact Person Public Query
Name
Amar Marode
Designation
MD Scholar
Affiliation
National Institute of Ayurveda
Address
Department of Kaumarbhritya, National Institute of Ayurveda, Jaipur
Jaipur RAJASTHAN 302002 India
Phone
9067145649
Fax
Email
amarmarode9119@gmail.com
Source of Monetary or Material Support
National Institute of Ayurveda
Primary Sponsor
Name
National Institute of Ayurveda
Address
Jorawar Singh gate, Amer Road, Jaipur, 302002
Type of Sponsor
Government medical college
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 Amar Marode
National Institute of Ayurveda Hospital
OPD No 05 and IPD of Department of Kaumarabhritya, Jorawar Singh Gate, Amer Road, Jaipur Jaipur RAJASTHAN
(1) Medicine Name: kushthadi ghrita, Reference: kashyapa samhita leha adhyaya, Route: Oral, Dosage Form: Ghrita, Dose: 2.5(g), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: Yes(details: Luke warm water), Additional Information: Dose vary according to age group
3-6 yrs - 2-3.5g per day
6-9yrs - 3.5-4.5g per day
9-12 yrs- 4.5-5.5 g per day(2) Medicine Name: panchabhautika taila, Reference: kashyapa samhita kalpa sthana, Route: Nasal, Dosage Form: Taila, Dose: 4(drops), Frequency: od, Bhaishajya Kal: Adhobhakta, Duration: 12 Weeks, anupAna/sahapAna: No, Additional Information: 2 drops to each nostril
with that occupational therapy
Sensory Integration Therapy including Brushing protocols, deep pressure massage, activities with sand clay
Fine Motor Skill Training including Drawing, coloring, Buttoning, zipping, tying laces, pegboard, Grasp, and release exercises
Gross Motor and Postural Control including Crawling, climbing, obstacle courses, Ball games
Activities of Daily Living (ADL) Training including Feeding, spoon use, Dressing, Toileting
Play Therapy and Social Participation including Cooperative tasks
Visual–Motor Integration including Puzzles Matching shapes and colors, Copying patterns, Eye hand coordination games
2
Comparator Arm (Non Ayurveda)
-
Occupational therapy
Sensory Integration Therapy including Brushing protocols, deep pressure massage, activities with sand clay
Fine Motor Skill Training including Drawing, coloring, Buttoning, zipping, tying laces, pegboard, Grasp, and release exercises
Gross Motor and Postural Control including Crawling, climbing, obstacle courses, Ball games
Activities of Daily Living (ADL) Training including Feeding, spoon use, Dressing, Toileting
Play Therapy and Social Participation including Cooperative tasks
Visual–Motor Integration including Puzzles Matching shapes and colors, Copying patterns, Eye hand coordination games
Inclusion Criteria
Age From
3.00 Year(s)
Age To
12.00 Year(s)
Gender
Both
Details
Children between the age group of 3-12 years of either sex.
Those meeting DSM V TR and AIIMS modified INCLEN criteria
Indian scale for assessment of Autism Score (ISAA) more than 70
ExclusionCriteria
Details
One who doesn’t meet DSM V TR and AIIMS modified INCLEN criteria
Children having any other psychotic or neurological disorder.
Children having any co-morbid conditions or congenital disorder or genetic syndromes like Rett’s Syndrome .
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Change in Indian Scale for Assessment of Autism (ISAA) score - To assess the effect of Kushthadi Ghrita along with Panchabhautika Taila Pratimarsha Nasya and Occupational Therapy on the severity of autism spectrum disorder, as measured by the change in total ISAA score from baseline to the end of 12 weeks of intervention.
Comparative improvement in ISAA score between study groups - To compare the mean change in ISAA scores between group A and group B at the end of the treatment period.
At the end of the study
Secondary Outcome
Outcome
TimePoints
Changes in ASD as per Ayurveda perspectives
At the end of the study
Target Sample Size
Total Sample Size="30" Sample Size from India="30" 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
N/A
Date of First Enrollment (India)
14/08/2026
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 Yet Recruiting
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
Autism Spectrum Disorder (ASD) is a complex neurodevelopmental condition characterized by deficits in social interaction, communication, and restricted, repetitive behaviors, with onset in early childhood. The rising prevalence of ASD and the limitations of conventional therapies necessitate the exploration of integrative, evidence-based treatment approaches. Ayurveda describes conditions comparable to ASD under Unmada and Vata Vyadhi, attributed to derangement of Dosha affecting Manovaha Srotas and Buddhi.
The present study aims to evaluate the efficacy of Kushthadi Ghrita orally along with Panchabhautika Taila Pratimarsha Nasya combined with Occupational Therapy, compared to Occupational Therapy alone, in the management of ASD in children aged 3–12 years.
This is an open-label, prospective, randomized controlled trial conducted at the National Institute of Ayurveda, Jaipur. A total of 30 children diagnosed with ASD (ISAA score >70) will be randomly allocated into two groups: Group A receiving Ayurvedic interventions along with occupational therapy, and Group B receiving occupational therapy alone, for a duration of 12 weeks.
The primary outcome measure is change in the Indian Scale for Assessment of Autism (ISAA) score, while secondary outcomes include changes in clinical features of ASD as per DSM-V-TR and Ayurvedic parameters. Statistical analysis will be performed using appropriate non-parametric tests.
This study seeks to generate clinical evidence for a holistic, integrative approach combining Ayurvedic therapeutics and occupational therapy, potentially offering a safe, effective, and sustainable management strategy for children with ASD.