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CTRI Number  CTRI/2025/08/093449 [Registered on: 21/08/2025] Trial Registered Prospectively
Last Modified On: 22/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   A Study on Behaviour Improvements in Autistic Children with Homoeopathic medicines 
Scientific Title of Study   Assessment of Behavioural Changes in Children with Autism Spectrum Disorder using Individualised Homoeopathic medicine: A Single Arm Study 
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 Leo Toby 
Designation  Pg Scholar 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  409, IIIrd floor, college Building, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9495217622  
Fax    
Email  leotoby123@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr D Bencitha Horrence Mary  
Designation  Associate Professor 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  409, IIIrd floor, college Building, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443064215  
Fax    
Email  dr.bencitha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr D Bencitha Horrence Mary  
Designation  Associate Professor 
Affiliation  Sarada Krishna Homoeopathic Medical College 
Address  409, IIIrd floor, college Building, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari District, Tamil Nadu

Kanniyakumari
TAMIL NADU
629161
India 
Phone  9443064215  
Fax    
Email  dr.bencitha@gmail.com  
 
Source of Monetary or Material Support  
Institution - Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari, Tamil Nadu, India 629161 
 
Primary Sponsor  
Name  Post Graduate research funded by college 
Address  Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari, Tamil Nadu, India 629161 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Leo Toby  Sarada Krishna Homoeopathic Medical College Hospital  Department of Paediatrics,Room no. 108,Ground Floor, Sarada Krishna Homoeopathic Medical College Hospital, Kulasekharam, Kanniyakumari, Tamil Nadu, India 629161
Kanniyakumari
TAMIL NADU 
9495217622

leotoby123@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Sarada Krishna Homoeopathic Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F840||Autistic disorder,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Medicines selected after repertorisation   The potency will be determined based on the patient’s susceptibility, with initial administration orally in 30C potency daily night for 1 year. Subsequent medicines and potencies will be selected after assessing the improvement during follow-up visits, and repetition will be guided by the degree of symptomatological improvement. 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Year(s)
Age To  15.00 Year(s)
Gender  Both 
Details  Patients of age group between 3 years to 15 years which are diagnosed as autism.
Children of both Genders
Patients having an under average and below average intelligence.
Patients with Indian scale for Assessment of Autism (ISAA) Scoring 70 and above will
be included for the study 
 
ExclusionCriteria 
Details  Patients with visual or hearing impairment.
Patients with unwilling parents.
Patients undergoing treatment for any systemic illnesses and other severe chronic
illnesses 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of behavioural enhancement in children diagnosed with Autism Spectrum
Disorder (ASD) through pre- and post-evaluation using the Indian scale for
assessment of autism (ISAA).  
1 Year 
 
Secondary Outcome  
Outcome  TimePoints 
Analysing parent-reported changes in behavioural patterns, emotional regulation, and
adaptive skills before and after treatment.

Improvement in quality of life and daily functioning.  
1 Year 
 
Target Sample Size   Total Sample Size="34"
Sample Size from India="34" 
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/ Phase 4 
Date of First Enrollment (India)   01/09/2025 
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="2"
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  

The dissertation titled Assessment of Behavioural Changes in Children with Autism Spectrum Disorder Using Individualised Homoeopathic Medicine: A Single Arm Study aims to evaluate the effectiveness of individualized homoeopathic treatment in managing behavioural symptoms in children with Autism Spectrum Disorder (ASD). Autism is a neurodevelopmental disorder marked by impairments in social interaction, communication, and repetitive behaviours, with a rising global prevalence. Although conventional treatments are available, they often come with limitations such as high cost, limited accessibility, and potential side effects. Homoeopathy, particularly in its individualized form, offers a potential alternative, but lacks strong scientific backing due to methodological inconsistencies in existing studies. This study addresses this gap by conducting a one-year interventional single-arm study involving 34 children aged 3 to 15 years, diagnosed with ASD using the Indian Scale for Assessment of Autism (ISAA) and ICD-10 criteria. The homoeopathic medicines are selected through classical case-taking and repertorisation methods. Behavioural outcomes are measured using pre- and post-treatment ISAA scores. The study hypothesizes that individualized homoeopathic medicine can significantly improve behavioural symptoms in children with ASD. Statistical analysis will be conducted to determine the effectiveness of the intervention. This research seeks to contribute to the growing evidence base on alternative therapies for ASD and promote a more integrative approach in paediatric health care.

 
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