| CTRI Number |
CTRI/2020/06/025871 [Registered on: 15/06/2020] Trial Registered Prospectively |
| Last Modified On: |
03/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to observe additional effect of ayurvedic treatment on Autism Spectrum Disorder in Children |
|
Scientific Title of Study
|
Add on effect of selected ayurvedic treatment modalities in the management of Autism Spectrum Disorder in Children |
| Trial Acronym |
ASD |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Snehal Vinayak kale |
| Designation |
Assistant Professor (YCAMC Aurangabad) PhD scholar (Parul University) |
| Affiliation |
Yashwantrao Chavan Ayurved medical Collage and Hospital Aurangabad Maharashtra |
| Address |
Room No 12
Department of
Kaumarbhritya
(Balroga)
Yashwantrao
Chavan Ayurved
Hospital Aurangabad
Maharashtra 431007
Aurangabad
MAHARASHTRA
Room No 12
Department of
Kaumarbhritya
(Balroga)
Yashwantrao
Chavan Ayurved
Hospital Aurangabad
Maharashtra 431007
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
8956072783 |
| Fax |
|
| Email |
snehalvkale088@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajanish Meti |
| Designation |
Professor (Kaumarbhritya department) (Parul Institute of Ayurveda, Parul University) |
| Affiliation |
Parul Institute of Ayurveda ,Parul University |
| Address |
Room No 103
Department of
Kaumarbhritya
(Balroga)
Parul Ayurveda Hospital, Parul University,P.O.Limda, Ta.Waghodia, Dist.Vadodara
Room No 103
Department of
Kaumarbhritya
(Balroga)
Parul Ayurveda Hospital, Parul University,P.O.Limda, Ta.Waghodia, Dist.Vadodara
Vadodara
GUJARAT
391760
India |
| Phone |
9986660145 |
| Fax |
|
| Email |
rajanishsm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Snehal Vinayak kale |
| Designation |
Assistant Professor (YCAMC Aurangabad) PhD scholar (Parul University) |
| Affiliation |
Yashwantrao Chavan Ayurved medical Collage and Hospital Aurangabad Maharashtra |
| Address |
Room No 12
Department of
Kaumarbhritya
(Balroga)
Yashwantrao
Chavan Ayurved
Hospital Aurangabad
Maharashtra 431007
Aurangabad
MAHARASHTRA
Room No 12
Department of
Kaumarbhritya
(Balroga)
Yashwantrao
Chavan Ayurved
Hospital Aurangabad
Maharashtra 431007
Aurangabad
MAHARASHTRA
Aurangabad
MAHARASHTRA
431007
India |
| Phone |
8956072783 |
| Fax |
|
| Email |
snehalvkale088@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shiva Trusts Yashwantrao Chavan Ayurved Medical Collage and Hospital Aurangabad Maharashtra 431007 |
| Parul University P.O Limda, Ta. Waghodia-391760 Dist. Vadodara, Gujarat |
|
|
Primary Sponsor
|
| Name |
Dr Snehal Vinayak Kale |
| Address |
Staff Quarter of Shiva Trusts Yashwantrao Chavan Ayurved Medical Collage and Hospital Aurangabad Maharashtra 431007 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Parul University |
Parul University, P.O. Limda, Ta. Waghodia-391760, Dist. Vadodara, Gujarat |
| Yashwantrao Chavan Ayurved Medical Collage and Hospital Aurangabad |
Shiva Trusts Yashwantrao Chavan Ayurved Medical Collage and Hospital Aurangabad Maharashtra 431007 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Snehal Vinayak Kale |
Yashwantrao Chavan Ayurved Hospital Aurangabad |
Room No 12 Department of Kaumarbhritya (Balroga) Yashwantrao Chavan Ayurved Hospital Aurangabad Maharashtra 431007
Aurangabad
MAHARASHTRA |
8956072783
snehalvkale088@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul Institute of Ayurved-Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F840||Autistic disorder, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Non Pharmacological therapies
(Applied Behavioral Analysis)
|
from 1st day to 180th day |
| Intervention |
Non Pharmacological therapies
(Applied Behavioral Analysis),Maha Paishachika Ghrita,Brahmi Ghrita ,Ksheer Bala taila,Ashwasana Chikitsa |
Non Pharmacological therapies
(Applied Behavioral Analysis)
from 1st day to 180th day,
Maha Paishachika Ghrita
3-16 grams (3-16 years) BD Oral from 91th day to 180th day,
Brahmi Ghrita
2 drops in each nostril OD Nasal Instillation from 91th day to 180th day,
Ksheer Bala taila
10-20 ml OD Shiro Abhyanga from 91th day to 180th day,
Ksheer Bala taila
10-20 ml OD Pada Abhyanga from 91th day to 180th day,
Ashwasana Chikitsa
Once in a month from 91th day to 180th day |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Fulfilling the diagnostic Criteria of Autism Spectrum Disorder according to
-Diagnostic and Statistical Manual of Mental disorders Fifth edition (DSM-5TM)(299.00)
-Childhood Autism Rating ScaleTM Second edition (CARSTM2)
-Indian Scale for Assessment of Autism (ISAA)
Parents/ Guardian willing to give informed written consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
Children below 3 years and above 16 years
Presence of other organic or psychotic neurological disorder
Hearing and visual impairment, Multiple disabilities
Patients with acute and chronic systemic illness such as renal diseases, Hepatic dysfunction, Juvenile diabetes mellitus, malignancy, etc
Progressive and non progressive neuromuscular disorders, Known neurodegenerative disorder
Hypoxic Ischemic Encephalopathy (HIE)
Endocrinal disorders, Protein Energy Malnutrition (PEM),etc
Children taking anti-epileptic and anti-psychotic drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in clinical features of Autism Spectrum Disorder assessed by 1.Autism Treatment Evaluation Checklist (ATEC)
2.Childhood Autism Rating Scale TM Second edition (CARSTM2)
3.Indian Scale for Assessment of Autism (ISAA)
|
Baseline 0 day and 90 days and End of treatment 180 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Changes in the quality of life of Parents
|
Baseline 0 day and 90 days and End of treatment 180 days |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 3 |
|
Date of First Enrollment (India)
|
01/07/2020 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a Randomized parallel group open label clinical trial to assess the clinical efficacy of Ayurvedic treatment modalities in the Management of Autism Spectrum Disorder in Children. For that Mahapaishachik Ghrita will be orally administered 3-16 gm (as per age of child of 3-16 years) twice daily with luke warm water or milk for 3 months, Nasal instillation (Nasya) of Brahmi Ghrita 2 drops in each nostril once daily for 3 months, External application of oil over head (Shiroabhyanga) with Ksheer Bala Taila (10-20 ml) for 10 minutes for 3 months, Ayurvedic foot massage (Padabhyanga) with Ksheer Bala Taila (10-20 ml) for 10 minutes (5 minutes on each foot) will be done before going to bed for 3 months along with Non Pharmacological therapies in children suffering from Autism Spectrum Disorder. To keep the transparency of distinguishing the exact effect of special treatment subject in trial group will be divided into two phases and treated i.e. Control group with only Non Pharmacological therapies for 6 months while Trial group treated with Non Pharmacological therapies for first 3 months (Phase I) and with Ayurvedic treatment modalities along with Non Pharmacological therapies for next 3 months (Phase II). The primary outcome is reduction in the clinical features of Autism Spectrum Disorder and the secondary outcome will be changes in the quality of life of parents at 90 days and 180 days.
|