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CTRI Number  CTRI/2024/05/067228 [Registered on: 13/05/2024] Trial Registered Prospectively
Last Modified On: 10/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To evaluate epidemiology and risk factors in autism spectrum disorder children visiting sir sunderlal hospital banaras hindu university  
Scientific Title of Study   EPIDEMIOLOGY AND RISK FACTORS IN CHILDREN WITH AUTISM SPECTRUM DISORDER VISITING SIR SUNDERLAL HOSPITAL BHU 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohan Kumar  
Designation  Post graduate diploma scholar  
Affiliation  Institute of medical sciences, BHU 
Address  Department of kaumarabhritya balrog faculty of Ayurveda institute of medical sciences Banaras Hindu University Varanasi Uttar Pradesh India

Varanasi
UTTAR PRADESH
221004
India 
Phone  7080943229  
Fax    
Email  mohan.k.singhal@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ravi Shankar khatri  
Designation  Assistant professor  
Affiliation  Institute of medical sciences,bhu 
Address  Department of kaumarabhritya balrog faculty of Ayurveda institute of medical sciences Banaras Hindu University Varanasi Uttar Pradesh India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9549182589  
Fax    
Email  drrskhatri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ravi Shankar khatri  
Designation  Assistant professor  
Affiliation  Institute of medical sciences,bhu 
Address  Department of kaumarabhritya balrog faculty of Ayurveda institute of medical sciences Banaras Hindu University Varanasi Uttar Pradesh India

Varanasi
UTTAR PRADESH
221005
India 
Phone  9549182589  
Fax    
Email  drrskhatri@gmail.com  
 
Source of Monetary or Material Support  
1.Opd no.25 Kaumarabhritya Balaroga opd Indian medicine wing sir sunderlal hospital BHU Varanasi Uttar pradesh India 221005 2.child psychology clinic department of pediatrics ims bhu sir sunder lal hospital Varanasi  
 
Primary Sponsor  
Name  Banaras Hindu University  
Address  Sir sunderlal hospital ims bhu Banaras Hindu University Varanasi Uttar Pradesh India 221005 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Ravi Shankar khatri   Sir sunderlal hospital   Opd no 25 Kaumarabhritya Balaroga opd Indian medicine wing sir sunderlal hospital BHU Varanasi Child psychology clinic department of pediatrics sir sunderlal hospital BHU Varanasi
Varanasi
UTTAR PRADESH 
9549182589

drrskhatri@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee institute of medical sciences Banaras Hindu University Varanasi Uttar Pradesh   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:F989||Unspecified behavioral and emotional disorders with onset usually occurring in childhood and adolescence. Ayurveda Condition: UNMADAH,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  16.00 Year(s)
Gender  Both 
Details  Children aged 3-16 years at the time of diagnosis, with a confirmed
diagnosis of ASD based on DSM-5 criteria /ISAA Test. 
 
ExclusionCriteria 
Details  Children with incomplete medical records or those who do not meet the
diagnostic criteria for ASD. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
prenatal,
perinatal and post natal influences,
environmental exposures
medical history  
prenatal,
perinatal and post natal influences, at registation and after 4 week
environmental exposures
medical history 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the age distribution of children diagnosed with ASD & identifies any significant
variations in risk factors among different age groups.
2. To explore the gender-based differences in the prevalence of risk factors & epidemiological
factors related to ASD among the studied population.
3. To analyze the comorbidities associated with ASD & their potential interactions with
identified risk factors.
4. To provide valuable clinical insights & recommendations based on the identified risk factors
and epidemiology, aiding in the early identification, intervention, & management of ASD in
children 
At registration & 4 weeks 
 
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)   21/05/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  21/05/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
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 biologically based neurodevelopmental disorder
characterized by core deficits in two key domains: social communication/interaction and
restrictive, repetitive patterns of behavior. The term "spectrum" in ASD acknowledges the
wide variability in how individuals are affected, with symptoms ranging from mild to severe,
often accompanied by overlapping comorbidities.
The prevalence of ASD is estimated at 1 in 59 persons by the U.S. Centers for Disease
Control and Prevention (CDC). The prevalence increased significantly over the past 25 years,
primarily because of improved diagnosis and case finding as well as inclusion of less severe
presentations within the autism spectrum. There is a 4:1 male predominance. The prevalence
is increased in siblings (up to 10% recurrence rate) and particularly in identical twins. There
are no racial or ethnic differences in prevalence. Individuals from racial minorities and lower
socioeconomic status are at risk for later diagnosis.
Autism: The Ayurvedic viewpoint
A behavioral abnormality with its roots situated in the malfunctioning neuropsychological system
and disorder in the digestive and metabolic system is considered to be an Unmada by Ayurveda.
There are places where one or more of the mental abilities can go wrong. There are various types
of inappropriate behavior shown by the person as a result of the distortion of the normal mind,
intellect, conscious awareness, memory, desire, manner, and behavior in the whole concept of
unmada.
In the concept of unmada, we see some of the affected faculties that can be seen in Autism
spectrum disorders. That involve impairments of
• Manas – mind-total or partial loss of sensory perception
• Buddhi—intellect—partially affected—could be irregular as shown in savant skill.
• Samjna Jnana – an aware presence – seen to be lost in their own environment, barring one
or more sensory stimuli.
• Bhakti – ability – inherent willingness to connect with others
• Seela – manners – socially inappropriate outbursts and adherence to strict rigid routines.
• Cheshta – Activities – Motor stereotypes that are improper and compulsive
• Achara – learned skills – poor socialization skills, failure to obey orders, loss of healthy
habits, etc.
• Knowledge of acquisition (Jnanotpathi), one of Manas; essential roles, is disrupted in
Unmada.
• Jnanotpathi occurs only when Manas is in tune with Atma (soul), Indriya (sense organ),
and Indriyartha (objects).

 
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