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CTRI Number  CTRI/2025/03/082928 [Registered on: 20/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of Ayurveda Treatment Protocol in Autism Spectrum Disorder 
Scientific Title of Study   Efficacy of Ayurveda Treatment Protocol in Autism Spectrum Disorder- A Randomised 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  Dr Pallavi Mishra 
Designation  MD scholar 
Affiliation  National Institute of Ayurveda  
Address  Department of Kaumarbhritya National Institute of Ayurveda

Jaipur
RAJASTHAN
302002
India 
Phone  8107372634  
Fax    
Email  mishpall13@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ProfDr Nisha Kumari Ojha  
Designation  Professor & HOD 
Affiliation  National Institute of Ayurveda  
Address  Department of Kaumarbhritya National institute of Ayurveda

Jaipur
RAJASTHAN
302002
India 
Phone  919468650449  
Fax    
Email  drnishaojha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ProfDr Nisha Kumari Ojha  
Designation  Professor & HOD 
Affiliation  National Institute of Ayurveda  
Address  Department of Kaumarbhritya National institute of Ayurveda

Jaipur
RAJASTHAN
302002
India 
Phone  919468650449  
Fax    
Email  drnishaojha@gmail.com  
 
Source of Monetary or Material Support  
NIA director  
 
Primary Sponsor  
Name  National Institute of Ayurveda deemed to be university 
Address  Jorawar singh gate Amer road Jaipur 302002 Rajasthan 
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 Pallavi Mishra   National Institute of Ayurveda Hospital   OPD no 5 Department of Kaumarbhritya
Jaipur
RAJASTHAN 
8107372634

mishpall13@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC National institute of ayurveda   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: MANOVAHASROTODUSHTIH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-daivavyapASraya-cikitsA, दैवव्यपाश्रय-चिकित्सा (Procedure Reference: charak samhita, Procedure details: om mantra audio listening for 15 minutes )
2Intervention ArmProcedure-nasyam/ nastam, नस्यम्/ नस्तम् (Procedure Reference: sahasrayoga, Procedure details: bilwadi gutika mixed with til taila will be instilled/ applied in nasal mucosa once a day.)
(1) Medicine Name: bilwadi gutika, Reference: sahasra yoga, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 5 Days
3Comparator Arm (Non Ayurveda)-Occupational Therapyoccupational therapy for 8 weeks it includes gross motor skills like walking, grooming, self eating, toilet training, dressing, sensory stimulation, communication skills etc to improve independence and quality of life.
4Intervention ArmProcedure-mAtrAbastiH, मात्राबस्तिः (Procedure Reference: charak samhita, Procedure details: luke warm brahmi ghrita will be administered via anal route by lying down the child on left lateral position after having some food)
(1) Medicine Name: brahmi ghrita, Reference: charak samhita, Route: Rectal, Dosage Form: Ghrita, Dose: 20(ml), Frequency: od, Duration: 15 Days
5Intervention ArmProcedure-satvAvajaya-cikitsA, सत्वावजय-चिकित्सा (Procedure Reference: charak samhita, Procedure details: sattavavajaya chikitsa- a non-pharmacological intervention similar to psychotherapy .. harshan, ashwashan (playful activities, storytelling etc for the cherished of child))
6Intervention ArmProcedure-picu, पिचु (Procedure Reference: ashtana sangraha, Procedure details: lukewarm jyotishmati taila soaked in a cotton pad will be tied on head with a cotton bandage. )
(1) Medicine Name: jyotishmati taila, Reference: raj nighantu, Route: Topical, Dosage Form: Taila, Dose: 2(ml), Frequency: od, Duration: 53 Days
7Intervention ArmDrugClassical(1) Medicine Name: trikatu churna, Reference: bhaisajya ratnavali, Route: Oral, Dosage Form: Churna/ Powder, Dose: 400(mg), Frequency: od, Bhaishajya Kal: Pragbhakta, Duration: 3 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: minimum dose- 125mg max dose- 750mg
8Intervention ArmDrugClassical(1) Medicine Name: saraswata ghrita, Reference: ashtanga hridaya, Route: Oral, Dosage Form: Ghrita, Dose: 2.25(ml), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 53 Days, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: minimum dose- 1.5ml maximum dose- 3ml
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Those meeting DSM V TR and AIIMS modified INCLEN criteria
ISAA score 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 / genetic syndromes 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Changes in ISAA score   at baseline 4 weeks
8 weeks 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Development of Ayurveda protocol for the management of ASD   12 weeks 
 
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   Phase 2 
Date of First Enrollment (India)   25/09/2025 
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)   Open to Recruitment 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [mishpall13@gmail.com].

  6. For how long will this data be available start date provided 25-09-2025 and end date provided 25-09-2030?
    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
Brief Summary  

Autism spectrum disorder is a neurodevelopmental and behavioural disorder that is characterised by a deficit in reciprocal social communication and stereotypical repetitive and restricted behaviour It is a complex impairment often appearing in early childhood The etiology is multifactorial and not fully understood Autism spectrum disorder ASD encompasses autistic disorder Aspergers syndrome and pervasive mental disorderThe clinical manifestations of ASD varies depending on the severity of the disorder  The prevalence of autism is rapidly increasing over the yearsThe global prevalence of autism is 1 in 100 as per the World Health Organization According to CDCs Autism and Developmental Disabilities Monitoring ADDM network about 1 in 36 children have been diagnosed with autism The prevalence of autism in India is 1 in 68 as per a study published in the Indian Journal of Pediatrics About 18 million children are affected by autism  Autism is 4 times more common in boys than girls Globally there has been a notable surge in occurrence of autism spectrum disorder Despite a lot of medical advancements there are no medications specifically to treat autism Secondgeneration antipsychotics risperidone and aripiprazole are two drugs that the US Food and Drugs Administration has approved for the treatment of autism It is efficacious in reducing some symptoms but it carries the risk of side effects like excessive weight gain hyperglycemia drowsiness sedation tremors and muscle stiffness The children may get relief from the previous symptoms with lots of new ones getting added Occupational therapy a psychosocial intervention is more popular in the management of autism that requires a significant investment of time and money placing a financial burden on families This increases a concern in health care professional and researchers ASD can be considered as a global pandemic which needs an early and effective intervention There is an equal and profound impact on the daytoday life of autistic individuals and their families The management of autism needs to be a multidisciplinary approach So in this context Ayurveda may play a significant role in the management of wellbeing cognition and overall behaviour Three treatment modalities are explained in the classical texts ofAyurveda viz daivavyapashraya yuktivyapashraya and sattvavajaya chikitsa This is a wholesome approach dealing with the physical mental as well as emotional wellbeing of the patient with minimal consumption of time and is costeffective This study is carried out to evaluate the effect of this treatment protocol in the management of ASD

 
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