| CTRI Number |
CTRI/2026/03/105469 [Registered on: 06/03/2026] Trial Registered Prospectively |
| Last Modified On: |
06/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Behavioral |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study the effect of a oral medicine in autism disorder |
|
Scientific Title of Study
|
Randomized controlled clinical trial to study the effect of herbomineral formulation in 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 Preetham Pai |
| Designation |
Professor |
| Affiliation |
College of Ayurved, Bharati Vidyapeeth (Deemmed to be University) |
| Address |
Department of Kaumarabhritya, College of Ayurved, Bharati Vidyapeeth (Deemmed to be University)
Pune
MAHARASHTRA
411043
India |
| Phone |
919765417555 |
| Fax |
|
| Email |
preetham.pai@bharatividyapeeth.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Meera Panicker |
| Designation |
Assistant Professor |
| Affiliation |
College of Ayurved, Bharati Vidyapeeth (Deemmed to be University) |
| Address |
Department of Kaumarabhritya, College of Ayurved, Bharati Vidyapeeth (Deemmed to be University)
Pune
MAHARASHTRA
411043
India |
| Phone |
919645238984 |
| Fax |
|
| Email |
Meera.panicker@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saniya Pathan |
| Designation |
Assistant Professor |
| Affiliation |
College of Ayurved, Bharati Vidyapeeth (Deemmed to be University) |
| Address |
Department of Kaumarabhritya, College of Ayurved, Bharati Vidyapeeth (Deemmed to be University)
Pune
MAHARASHTRA
411043
India |
| Phone |
917057554185 |
| Fax |
|
| Email |
saniya.pathan@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth Ayurved hospital,katraj,Pune-411043.India
|
|
|
Primary Sponsor
|
| Name |
Bharati Vidyapeeth (Deemed to be University) |
| Address |
Bharati Vidyapeeth Bhavan,Lal Bhahadur Shastri road,Sadashiv Peth Pune-411030, Maharashtra |
| Type of Sponsor |
Other [Private university] |
|
|
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 Preetham Pai |
Blaroga OPD, Bharati Ayurved Hospital |
Bharati Ayurved Hospital,opd no 9,Balrog.katraj .pune
Pune
MAHARASHTRA |
919765417555
preetham.pai@bharatividyapeeth.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BV(DU)COA-IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F840||Autistic disorder. Ayurveda Condition: UNMADAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | Behavioural Therapy | Behavioural Therapy for 90 days | | 2 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Manasmitra Vatakam, Reference: Sahasrayogam, Gutika Prakaranam, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1(NA), Frequency: bd, Bhaishajya Kal: Pragbhakta, Duration: 90 Days, anupAna/sahapAna: No, Additional Information: 2-5 years - ½ Tab BID
5-10 years - 1 Tab BID
|
|
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
a) Children of either gender, aged between 2 - 10 years
b) Diagnosed with Autism spectrum disorder(Diagnostic and Statistical Manual of Mental Disorders V criteria)
c) Children in the vicinity of the Dhankawadi area.
d) Parents who are willing to give consent for the child’s participation in the study
|
|
| ExclusionCriteria |
| Details |
a) Children on anti-epileptic medications.
b) ASD medications from any other disciplines for more than 1 week.
c) Children with co-morbid conditions like cerebral palsy, mental retardation or any other chronic neurological or metabolic disorders.
d) Known case of any known syndrome.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The primary outcome is to correct the impairment of social interaction and improve communication and imagination in children with ASD, along with the correction of repetitive behaviour, along with achievement of eye contact and being able to respond when called by name.
|
90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is acquisition of speech and language |
90 days |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
21/03/2026 |
| 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="11"
Days="29" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 a disorder of neural development characterized by impaired social interaction and communication and by restricted and repetitive behavior. It is the commonest of the pervasive developmental disorders with considerable genetic etiological factors. Based on clinical features it can be correlated with Unmada (psychological disorder mentioned in Ayurvedic text book-Charaka Samhita). Manasa Mitra Vatakam is Manodoshahara and is indicated in all types of Mano Dosha, Prabala Unmada, etc. Animal studies done on Manamitra Vataka shows that it improves cognition, enhances long term memory, reduces anxiety, and improves behaviour. Manasamitra Vataka contains mineral components like Swarna Bhasma, Tamra Bhasma, Swarnamakshika Bhasma, Loha Bhasma, and Rajata Bhasma. A toxicity study of Manasamitra Vataka has been done on animals and is proved to be safe. Hence it is decided to study the effect of Manasamitra Vatakam and cognitive behavioral therapy on Autism Spectrum Disorders (ASD). |