| CTRI Number |
CTRI/2023/06/054123 [Registered on: 19/06/2023] Trial Registered Prospectively |
| Last Modified On: |
15/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Brahmi Ghrita & Brahmi Tail Nasya With cognitive behavior therapy in Autism Spectrum Disorder |
|
Scientific Title of Study
|
Measure the efficacy of Brahmi Ghrita & Brahmi Tail Nasya along with cognitive behavior therapy in Autism Spectrum Disorder in children-Two arm open label prospective trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jigyasha |
| Designation |
MD Scholar |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Post Graduate Institution of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9462464995 |
| Fax |
|
| Email |
maharishijigyasa13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Prem Prakash Vyas |
| Designation |
DEAN RESEARCH Professor Head of Department Of Kaumarbhritya |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Room No 155
department of kaumarbhritya
Post Graduate Institution of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9660057022 |
| Fax |
|
| Email |
drppvyas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Prem Prakash Vyas |
| Designation |
DEAN RESEARCH Professor Head of Department Of Kaumarbhritya |
| Affiliation |
Post Graduate Institute of Ayurved |
| Address |
Room No 155
department of kaumarbhritya
Post Graduate Institution of Ayurved
Dr Sarvepalli Radhakrishnan Rajasthan Ayurved University
Jodhpur
RAJASTHAN
342037
India |
| Phone |
9660057022 |
| Fax |
|
| Email |
drppvyas@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Ayurved dr Sarvepalli Radhakrishnan Ayurved University Kadwad Jodhpur Rajasthan |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Ayurved |
| Address |
P G Department of Kaumarbhritya
Post Graduate Institution of Ayurved |
| 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 Jigyasha |
Post Graduate Institute of Ayurved |
Department of Kaumarbhritya OPD no 4 Post Graduate Institute of Ayurved Dr Saevepalli Radhakrishnan Rajasthan Ayurved University Jodhpur Rajasthan
Jodhpur
RAJASTHAN |
9462464995
maharishijigyasa13@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Post Graduate Institution of Ayurved |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F99||Mental disorder, not otherwise specified. Ayurveda Condition: MANOVAHASROTOVIKARAH, (2) ICD-10 Condition:G||Mental Health. Ayurveda Condition: MANOVAHASROTOVIKARAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | nasyam/ nastam, नसà¥à¤¯à¤®à¥/ नसà¥à¤¤à¤®à¥ | (Procedure Reference: Rastantrasaar and siddha prayog sangrah, Procedure details: Pratimarsh Nasya will be given as 2 drops in each nostrils)
(1) Medicine Name: Brahmi tail, Reference: Rastantrasaar and siddha prayog sangrah, Route: Nasal, Dosage Form: Bindu/ Drops/ Spray (Karna/ Nasa/ Netra/ Mukha), Dose: 2(drops), Frequency: bd, Duration: 60 Days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Brahmi Ghrita, Reference: Ashtang Hridyam, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: -Lukewarm milk), Additional Information: -Doses will be decide according to youngs formula | | 3 | Intervention Arm | Lifestyle | - | - | Dinacarya: No specific Dincharya will be given, Ritucarya: No specific Ritucharya will be given, Acara Rasayana:No specific Achara Rasyana will be given, Other:Cognitive behavior therapy will be given for 60 days along with Brahmi Ghrita and Brahmi tail Nasya, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
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Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
1 Diagnosed cases of Autism satisfying DSM V
criteria of either sex will be included
2 Patients with score above 70 in Indian Scale for
assessment of Autism will be included
3 Age between 3 to 16 years will be included |
|
| ExclusionCriteria |
| Details |
1 Patient with score below 70 Indian Scale for
assessment of Autism
2 ASD medications from any other system
3 Patients having mental retardation cerebral palsy
4 patients having presence of other organic or
psychotic neurological disorder |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measure the Efficacy of Brahmi Ghrita and Brahmi Tail Nasya along with Cognitive Behavior Therapy in the management of Autism Spectrum Disorder in 30 Childrens |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Brahmi Ghrit & Brahmi Tail Nasya with Cognitive Behavior Therapy will be
helpful to improve quality of life of children suffering from ASD.
o Change in ISAA score/ ATEC score.
|
60 Days |
|
|
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| 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="0"
Months="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Number of Patient- 30 Type of Study- Open label Drug- Brahmi Ghrit and Brahmi Tail Dose- Brahmi Ghrit will be in dose in two divided doses as per Young Formula. While Brahmi Tail will be given in 2 drops in each nose Anupana- Oral medicine will be given with Luke warm milk Route- Brahmi Ghrit- Oral Route Brahmi Tail- Nasal Route Randomization- Non Random Duration of Study- 60 days with follow up Follow up- Every fortnightly during the study and 120 days after completion of the
study.
|