FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/09/095250 [Registered on: 22/09/2025] Trial Registered Prospectively
Last Modified On: 20/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda
Behavioral 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Ashwagandhadi Taila with Occupational Therapy in Autism Spectrum Disorder in children 
Scientific Title of Study   A Randomized Open Label Comparative Controlled Clinical Trial to evaluate the efficacy of Ashwagandhadi Taila with Occupational Therapy in the Management of Autism Spectrum Disorder in Children 
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 Pankaj Dahiya 
Designation  MD scholar 
Affiliation  Institute for Ayurved Studies and Research 
Address  Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9871380231  
Fax    
Email  pankajdahiya1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amit Kataria 
Designation  Professor PG Dept. of Kaumarbhritya  
Affiliation  Institute for Ayurved Studies and Research 
Address  Room number 99 Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9034001230  
Fax    
Email  dramitkataria@rediffmail.com   
 
Details of Contact Person
Public Query  
Name  Dr Pankaj Dahiya 
Designation  MD scholar 
Affiliation  Institute for Ayurved Studies and Research 
Address  Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Kurukshetra

Kurukshetra
HARYANA
136118
India 
Phone  9871380231  
Fax    
Email  pankajdahiya1999@gmail.com  
 
Source of Monetary or Material Support  
Institute for Ayurved Studies and Research Shri Krishna AYUSH University Umri Road Sector 8 Kurukshetra 136118 India  
 
Primary Sponsor  
Name  Institute for Ayurved Studies and Research 
Address  Institute for Ayurved Studies and Research umri road sector 8 Kurukshetra 136118 Haryana 
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 Pankaj Dahiya  Institute for Ayurved Studies and Research  Department of Kaumarbhritya Institute for Ayurved Studies and Research Umri Road Sector 8 Kurukshetra 136118 Haryana
Kurukshetra
HARYANA 		 9871380231

pankajdahiya1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Shri Krishna AYUSH University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Comparator Arm (Non Ayurveda)-Occupational TherapyOccupational therapy improves fine and gross motor skills, enhance sensory processing, boost social interaction and play skills which focuses on improving daily living, communication, social, motor and sensory skills in Autism Spectrum Disorder adolescents
2Intervention ArmProcedure-saravA~gga, सर्वांग  (Procedure Reference: Ashtanga Hridaya Sutrasthanam 2/15, Procedure details: It will be done for the 1st 7 days of every course. Total 3 courses will be there with an interval of 16 days.)
(1) Medicine Name: Ashwagandhadi tailam, Reference: Ashtanga Sangraha Uttartantra 9/24, Route: Topical, Dosage Form: Taila, Dose: 50(ml), Frequency: od, Duration: 7 Days
3Intervention ArmProcedure-pratimarSaH, प्रतिमर्श (Procedure Reference: Ashtanga Hridaya Sutrasthanam 20/26-32, Procedure details: It will be done for the 1st 7 days of every course. Total 3 courses will be there with an interval of 16 days.)
(1) Medicine Name: Ashwagandhadi tailam, Reference: Ashtanga Sangraha Uttartantra 9/24, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 7 Days
4Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: Ashtanga Hridaya Sutrasthanam 19/68, Procedure details: Average dose is given here which will be calculated as per Clarks formula. Matra Basti will be done from 11th to 19th day of each course. Total 3 courses will be there with an interval of 16 days.)
(1) Medicine Name: Ashwagandhadi tailam, Reference: Ashtanga Sangraha Uttartantra 9/24, Route: Rectal, Dosage Form: Taila, Dose: 20(ml), Frequency: od, Duration: 9 Days
5Intervention ArmDrugClassical(1) Medicine Name: Ashwagandhadi tailam, Reference: Ashtanga Sangraha Uttartantra 9/24, Route: Oral, Dosage Form: Taila, Dose: 7(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 16 Days, anupAna/sahapAna: No, Additional Information: Snehapan will be given after 1st and 2nd sitting.
 
Inclusion Criteria  
Age From  2.00 Year(s)
Age To  9.00 Year(s)
Gender  Both 
Details  1. Parents of children willing to participate in the research trial.
2. Diagnosed cases of Autism satisfying AIIMS modified INCLEN criteria.
3. Patients with score above 70 in Indian Scale for assessment of Autism (ISAA).
4. Children of age group 2-9 years. irrespective of caste, sex, religion and socioeconomic status. 
 
ExclusionCriteria 
Details  1. Patients in age below 2 year and above 9 years.
2. One who doesn’t meet AIIMS modified INCLEN criteria and Patients with score below 70
in Indian Scale for assessment of Autism (ISAA).
3. Patients having mental retardation, cerebral palsy.
4. Patients having presence of other organic or psychotic neurological disorder.
5. Patients having hearing and visual impairment.
6. Patients having acute and chronic systemic illness such as renal diseases, hepatic
dysfunction, juvenile diabetes mellitus etc.
7. Patients having genetic syndrome like fragile X syndrome, turner syndrome , Retts
syndrome etc.
8. Patients having progressive and non-progressive neuromuscular disorders.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
It will be assessed on the basis of improvement in the domains of ISAA scale.  80 days 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in the feedback of Parents which will be assessed by Autism Parenting Stress
Index.  		 80 days 
 
Target Sample Size   Total Sample Size="12"
Sample Size from India="12" 
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/ Phase 3 
Date of First Enrollment (India)   01/12/2025 
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), understood in Ayurveda as a form of Unmada, is a neurodevelopmental condition that impairs communication, behavior, and social interaction in children. Conventional management is supportive, and there is still no definitive cure, which highlights the need for integrative approaches such as Ayurveda along with Occupational Therapy.randomized clinical study is planned to assess the effect of combining Occupational Therapy with Ayurvedic intervention (Ashwagandhadi Taila) in children with Autism Spectrum Disorder (ASD), correlated with Unmada in Ayurveda. The intervention group will receive Occupational Therapy along with Abhyanga, Nasya, Matra Basti, and Sneha Pana (three sittings of Abhyanga, Nasya and Matra basti for 16 days each, with Sneha Pana also continued for 16 days between the first and second sittings). The control group will receive only Occupational Therapy. The total study duration is 80 days, and assessments will be carried out before and after treatment using the Indian Scale for Assessment of Autism (ISAA) and the Autism Parenting Stress Index (APSI). This study aims to determine whether integrated Ayurvedic and Occupational Therapy provides additional benefits compared to Occupational Therapy alone in improving symptoms and reducing parental stress in ASD children. 
Close