| CTRI Number |
CTRI/2025/02/080502 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
31/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ayurveda Panchakarma therapies in Autism |
|
Scientific Title of Study
|
An open label randomized controlled clinical trial to evaluate the efficacy of multimodality Ayurveda interventions in the management of Autism Spectrum Disorder. |
| 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 Riya Patel |
| Designation |
PG Scholar |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9624219700 |
| Fax |
|
| Email |
riyapatel2634@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Swapnil C Raskar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9726587013 |
| Fax |
|
| Email |
swapnil.raskar@paruluniversity.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Swapnil C raskar |
| Designation |
Professor |
| Affiliation |
Parul Institute of Ayurved |
| Address |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Vadodara Gujarat
Vadodara
GUJARAT
391760
India |
| Phone |
9726587013 |
| Fax |
|
| Email |
swapnil.raskar@paruluniversity.ac.in |
|
|
Source of Monetary or Material Support
|
| Parul University Limda Vadodara Gujarat India 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Institute of Ayurved |
| Address |
Parul Institute of Ayurved Parul University At post Limda Waghodia Vadodara Gujarat India 391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Riya Patel |
Parul Institute of Ayurved |
Room 204 Department of Kaumarbhritya Parul Institute of Ayurved Parul University Vadodara Gujarat
Vadodara
GUJARAT |
9624219700
riyapatel2634@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Parul Institute of Ayurved Parul University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F988||Other specified behavioral and emotional disorders with onset usually occurring in childhood and adolescence. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Other than Classical | | (1) Medicine Name: Aurokid Plus, Reference: NA, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/Tablets, Dose: 500(mg), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 60 Days, anupAna/sahapAna: Yes(details: Madhu), Additional Information: - | | 2 | Intervention Arm | Procedure | - | Pratimarsha Nasya | (Procedure Reference: Astanga Hridaya, Procedure details: •No specific poorva karma is required except for that the child should be free of natural urges
•Child is made to sit comfortably in a chair or lie down comfortably in mother’s lap or on the table with head slightly extended
•2 drops of medicine are instilled into each nostril & child is asked to inhale properly
•Child can spit if at all any secretions come in the throat
•Child can resume normal activities immediately after the procedure.
)
(1) Medicine Name: Panchendriya Vivardhan Taila, Reference: Kashyapa Samhita Shatkalpa Adhyay, Route: Nasal, Dosage Form: Taila, Dose: 2(drops), Frequency: od, Duration: 60 Days | | 3 | Intervention Arm | Procedure | - | Behaviour Therapy | (Procedure Reference: -, Procedure details: -)
| | 4 | Comparator Arm (Non Ayurveda) | | - | Behaviour Therapy | - | | 5 | Intervention Arm | Procedure | - | Shiropichu | (Procedure Reference: Astanga Hridaya, Procedure details: Method of preparation of Pichu:
Approximately 3 inches square, quarter inch thick pad of cotton wool is wrapped in cotton gauze. Oil is heated in water bath to make it lukewarm, around 10 ml of oil is poured on the pad.
Procedure:
Before Procedure-
•First do abhyanga over Head, Neck & Shoulder.
Position of patient-
•Child is made to sit on a knee-high chair, his body is wrapped with cloth below the neck.
•In toddlers & neonate procedure is done in supine position.
•Placing the pad & Bandaging.
•Prepared pichu is placed on the vertex exactly on the anterior fontanelle.
•Tie the pichu with roller cotton bandage, passing behind the ear and comfortably tie in front of the neck.
•This bandage will allow the cotton pad to firmly in touch with scalp.
•Generally, pichu is maintain for 30 – 90 minutes. If required it may be left in position for the whole day.
After procedure-
•Remove the pichu & wipe the head completely.
)
(1) Medicine Name: Durva Brahmi Ghrita, Reference: -, Route: Topical, Dosage Form: Ghrita, Dose: 10(ml), Frequency: od, Duration: 60 Days |
|
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patient with known cases of ASD children belonging to the age group of 5 to 12 years, irrespective of gender, caste, religion and socio- economic status.
|
|
| ExclusionCriteria |
| Details |
Patients with known case of acute and chronic systemic illness such as renal disease, hepatic dysfunction, malignancy, tuberculosis.
ASD associated with other neurobehavior or neurodevelopmental disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement in Cognition on ISAA Scale
Improvement in Social behaviour and speech |
Day 30 day 60 and Day 90 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in Quality of life |
Day 30 day 60 and Day 90 |
|
|
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)
|
18/02/2025 |
| 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 Applicable |
| 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 is Neurobehavioral disorder with wide range of clinical features and presentations. behavioral therapy is the established medical management for the same. Ayurveda therapies which helps to improve the cognition and concentration along with gold salts is is helpful to treat the clinical outcome of the disease. present trial highlights abd aim to establish the Ayurveda therapy alomg with conventional behaviour therapy |