| CTRI Number |
CTRI/2025/09/095268 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Ayurveda |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
EVALUATION OF BRAHMI GHRITA MATRA BASTI AND BRAHMI GHRITA IN CHILDREN WITH AUTISM |
|
Scientific Title of Study
|
CLINICAL EVALUATION OF BRAHMI GHRITA MATRA BASTI AND BRAHMI GHRITA ORALLY IN AUTISM |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MONIKA |
| Designation |
PG SCHOLAR |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
ROOM NO. 402, Kaumarbhritya Department Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Delhi Haridwar Highway 58 Haridwar Uttarakhand India
ROOM NO. 402, Kaumarbhritya Department Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Delhi Haridwar Highway 58 Haridwar Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7027410924 |
| Fax |
|
| Email |
monikanonu310@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr BHARAT SETHI |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
ROOM NO. 402, Kaumarbhritya Department Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Delhi Haridwar Highway 58 Haridwar Uttarakhand India
ROOM NO. 402, Kaumarbhritya Department Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Delhi Haridwar Highway 58 Haridwar Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9416401686 |
| Fax |
|
| Email |
dr.bharatsethi17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRIYANKA WADHWA |
| Designation |
ASSOCIATE PROFFESOR |
| Affiliation |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
ROOM NO. 402, Kaumarbhritya Department Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Delhi Haridwar Highway 58 Haridwar Uttarakhand India
ROOM NO. 402, Kaumarbhritya Department Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar Delhi Haridwar Highway 58 Haridwar Uttarakhand India
Hardwar
UTTARANCHAL
249405
India |
| Phone |
8105938267 |
| Fax |
|
| Email |
pwadhwa13@gmail.com |
|
|
Source of Monetary or Material Support
|
| PATANJALI BHARTIYA AYURVIGYAN EVAM ANUSANDHAN SANSTHAN |
|
|
Primary Sponsor
|
| Name |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
| Address |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Delhi Haridwar Highway 58 Haridwar Uttarakhand India |
| Type of Sponsor |
Private 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 Monika |
Patanjali Bhartiya Ayurvigyan Anusandhan Sansthan |
Room no 402 Kaumarbhritya Department Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Phase 1 Delhi Haridwar Highway 58 Haridwar Uttarakhand India
Hardwar
UTTARANCHAL |
7027410924
monikanonu310@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan Haridwar(uttarakhand) |
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: UNMADAH, (2) ICD-10 Condition:F23||Brief psychotic disorder. Ayurveda Condition: UNMADAH, (3) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Brahmi Ghrita, Reference: Astanga Hridya, Route: Oral, Dosage Form: Ghrita, Dose: 5(ml), Frequency: od, Bhaishajya Kal: Abhakta, Duration: 30 Days, anupAna/sahapAna: No, Additional Information: -If child WILL DENY WITHOUT SEHPAN AND ANUPAN GIVE IT BY ADDING IN MILK | | 2 | Intervention Arm | Procedure | - | mAtrAbastiH | (Procedure Reference: KASHYAPA KHILA STHANA CHAPTER 8, Procedure details: ONCE A DAY
AFTER MEAL)
(1) Medicine Name: Brahmi Ghrita, Reference: Astanga Hridya, Route: Rectal, Dosage Form: Ghrita, Dose: 24(ml), Frequency: od, Duration: 7 Days |
|
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosed cases of Autism satisfying DSM V Criteria.
2.Children from 3 to 12 years, irrespective of gender, religion.
3.Parents / guardian willing to give informed written consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
i.Patients having mental retardation, cerebral palsy, seizures, epilepsy.
ii.Patients having presence of other organic or psychotic neurological disorder.
iii.Patients having hearing and visual impairment.
iv. Patients having acute and chronic systemic illness such as renal diseases, hepatic dysfunction, juvenile diabetes mellitus etc.
v. Patients having any other congenital disorders.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Assess improvement in core symptoms of ASD using CARS.
2. Assess behavioral improvement using ABC.
3. Compare oral Brahmi Ghrita with Brahmi Ghrita Matra Basti plus oral administration. |
1. DAY 7 OF TREATMENT
2. DAY 15 OF TREATMENT
3. DAY 30 OF TREATMENT
4. DAY 45 AFTER TREATMENT |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| A BETTER MANAGEMENT OUTCOMES IN AUTISM THROUGH BIOLOGICAL METHODS |
15 DAYS
30 DAYS
45 DAYS |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
07/10/2025 |
| 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 Yet Recruiting |
| 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 Spectrum Disorder (ASD) is a neurodevelopmental disorder with impaired communication, restricted interests, and repetitive behaviors. Current medicines only manage associated symptoms and have side effects. Ayurveda describes a similar condition under Unmada. Brahmi Ghrita is a classical Medhya Rasayana useful for cognition, memory, and speech, while Matra Basti is beneficial in Vata Vyadhi.
This randomized comparative clinical study will evaluate oral Brahmi Ghrita versus Brahmi Ghrita Matra Basti with oral administration in 60 children (3–12 years) diagnosed with ASD as per DSM-V criteria. Group A will receive oral Brahmi Ghrita for 30 days; Group B will receive Matra Basti for 7 days followed by oral administration for 23 days.
Efficacy will be assessed using the Childhood Autism Rating Scale (CARS) and Aberrant Behavior Checklist (ABC). The study aims to establish a safe, cost-effective Ayurvedic intervention for Autism Spectrum Disorder. |