| 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
|
|
|
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
|
|
|
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
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details |
|
|
|
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. |