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
|
|
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
|
|
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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
Intervention / Comparator Agent
|
sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | 1 | Intervention Arm | Procedure | - | daivavyapASraya-cikitsA, दैवव्यपाश्रय-चिकित्सा | (Procedure Reference: charak samhita, Procedure details: om mantra audio listening for 15 minutes )
| 2 | Intervention Arm | Procedure | - | 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 | 3 | Comparator Arm (Non Ayurveda) | | - | Occupational Therapy | occupational 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. | 4 | Intervention Arm | Procedure | - | 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 | 5 | Intervention Arm | Procedure | - | 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))
| 6 | Intervention Arm | Procedure | - | 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 | 7 | Intervention Arm | Drug | Classical | | (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 | 8 | Intervention Arm | Drug | Classical | | (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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mishpall13@gmail.com].
- 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.
- 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 |