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CTRI Number  CTRI/2025/03/083299 [Registered on: 25/03/2025] Trial Registered Prospectively
Last Modified On: 25/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Longitudinal 
Study Design  Other 
Public Title of Study   Development and validation of a preliminary diagnostic tool for Autism Spectrum Disorder (ASD) based on the Ayurveda concept of Unmada, involving 50 participants to establish a standardized approach for diagnosis and prognosis. 
Scientific Title of Study   Designing and Validation of a Preliminary Diagnostic Tool for Unmada W.S.R to 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. Manisha U K  
Designation  MD Scholar (Manasaroga). 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi. 
Address  OPD-3, Department of Manovijnana avum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi.
OPD-3, Department of Manovijnana avum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi.
Udupi
KARNATAKA
574118
India 
Phone  8296362917  
Fax    
Email  manuuday1998@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Dhaneshwari H A  
Designation  B.A.M.S., M.D. (Ayu), serves as an Assistant Professor in the Department of Kayachikitsa and Manasaroga. 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi. 
Address  OPD-3, Department of Manovijnana avum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi.
OPD-3, Department of Manovijnana avum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi.
Udupi
KARNATAKA
574118
India 
Phone  9900554202  
Fax    
Email  drdhaneshwarisdm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr. Dhaneshwari H A 
Designation  B.A.M.S., M.D. (Ayu), serves as an Assistant Professor in the Department of Kayachikitsa and Manasaroga. 
Affiliation  Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi. 
Address  OPD-3, Department of Manovijnana avum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi.
OPD-3, Department of Manovijnana avum Manasaroga, Sri Dharmasthala Manjunatheshwara College of Ayurveda, Kuthpady, Udupi.
Udupi
KARNATAKA
574118
India 
Phone  9900554202  
Fax    
Email  drdhaneshwarisdm@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara Ayurveda Pharmacy,. Laxminarayana Nagar,. P.O. Kuthpady - 574 118,. Udupi Dist., Karnataka. 
 
Primary Sponsor  
Name  NIL  
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Manisha U K  Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital  OPD-3, Department of Manovijnana avum Manasaroga, Kuthpady, Udupi
Udupi
KARNATAKA 
8296362917

manuuday1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Clearance Committee-Human, Sri Dharmasathala Manjunatheshwara College Of Ayurveda, Hospital And Research Centre, Kuthpady, Udupi.  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F01-F99||Mental, Behavioral and Neurodevelopmental disorders. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Diagnosed ASD patients from the age group of 3 to 18 years, who are accompanied by a
parent/ legal guardian from Sri Dharmasthala Manjunatheshwara College of Ayurveda and
Hospital, Udupi.
2. Parent / legal guardian of the patient, who are ready to give the assent 
 
ExclusionCriteria 
Details  1. As there is no intervention and diagnosed case of ASD patients are taken, no exclusion
parameters will be considered. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A Reliable and Validated Preliminary Diagnostic Tool for Unmada w.s.r to Autism Spectrum Disorder
 
1st day
8th day
15th day

 
 
Secondary Outcome  
Outcome  TimePoints 
Developing a diagnostic tool will bring uniformity in
diagnosis, prognosis along with standardization in clinical approach has become the need of hour 
15 days 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   01/05/2025 
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  

Unmada encompasses a range of psychosomatic mental disorders affecting the Manovaha Srotas, defined by derangement in eight domains: Mana (thinking process), Buddhi (intellect), Sanjnajnana (consciousness), Smriti (memory), Bhakti (desire), Sheela (temperament), Chesta (behavior), and Achara (conduct).

Correlation with Autism Spectrum Disorder (ASD)
ASD exhibits similarities to Unmada and can be better understood through these eight domains. ASD is the third most common developmental disorder globally, with a prevalence of 1 in 110 children in India. It is characterized by impairments in social interaction, communication, and repetitive behaviors. The etiopathogenesis is multifactorial, involving genetic and environmental factors.

Significance of a Diagnostic Tool
Modern systems like DSM-5 and ICD provide diagnostic criteria, but Ayurveda identifies conditions based on Pratyatma Lakshana (cardinal features) and Dosha predominance. Minimal work has been done to integrate these perspectives into a unified diagnostic tool for Unmada with respect to ASD. Developing and validating such a tool can standardize diagnosis and improve clinical utility.

Methodology
A scale incorporating Ayurvedic and modern diagnostic principles will be developed and validated. Literature will be reviewed, and items categorized into eight domains. The scale will undergo face, content, and construct validation by experts and will be tested for internal consistency using Cronbach’s alpha. External consistency will be assessed through test-retest and inter-rater reliability.

Study Design
The study involves observational assessment of 50 diagnosed ASD patients (ages 3–18) at SDM College of Ayurveda, Udupi. Validation will include comparison with the Indian Scale for Assessment of Autism (ISAA).

Inclusion Criteria
Diagnosed ASD cases accompanied by consenting guardians.

Exclusion Criteria
None, as the study is observational.

Duration
15 days.

 
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