| 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
|
|
|
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
|
|
|
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
|
|