| CTRI Number |
CTRI/2025/09/094431 [Registered on: 09/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of homoeopathy in the treatment of autism spectrum disorder in children |
|
Scientific Title of Study
|
Effect of Individualised Homoeopathic Medicines in the Management of Autism Spectrum Disorder in Children 5 12 years a Prospective Single Arm Clinical Trial |
| 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 Radhika |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G20
Department of Paediatrics
Ground floor
Plot no 36B Knowledge Park Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8920661435 |
| Fax |
|
| Email |
kradhika992@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ritu Gontiya |
| Designation |
Associate Professor of Department of Paediatrics |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G20
Department of Paediatrics
Ground floor
Plot no 36B Knowledge Park Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9999407479 |
| Fax |
|
| Email |
drritugontiya1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Garg |
| Designation |
Professor and HOD |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No G20
Department of Paediatrics
Ground Floor
Plot No 36B Knowledge Park
Phase 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9411437669 |
| Fax |
|
| Email |
drpuneetgarg18@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital
Room no G22
Principal Office
Ground Floor
Plot No 36B
Knowledge Park phase 1
Greater Noida
Uttar Pradesh
201306 |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Bakson Homoeopathic Medical College and Hospital
Room no G22
Principal Office
Ground Floor
Plot No 36B
Knowledge Park Phase 1
Greater Noida
Uttar Pradesh 201306 |
| Type of Sponsor |
Private medical college |
|
|
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 Radhika |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department
Room no 1
Ground floor
Plot no 36B Knowledge Park Phase 1
Greater Noida
Uttar Pradesh
201306
Gautam Buddha Nagar
UTTAR PRADESH |
8920661435
kradhika992@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson 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 |
Individualised Homoeopathic Medicine |
Pill form of administration
Oral route of administration
30 pill size
Centesimal scale
First dose after initial case taking
Repetition of dose according to follow up every 4 weeks for 24 weeks. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Participants of 5 to 12 years of age irrespective of their gender
Clinically diagnosed cases of Autism Spectrum Disorder
Participants whose parents or legally authorized guardian are willing to give consent for the study |
|
| ExclusionCriteria |
| Details |
Participants having any comorbid infection like tuberculosis with severe symptoms or history of severe and frequent violent exacerbations that required allopathic medication and hospitalization
Participants with uncontrolled or unstable psychiatric conditions that could affect participation in the study
Participants who are taking behaviour modifying drugs
Participants who are currently involved in other clinical trials or interventions that might conflict with or bias the outcomes of this study |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the effect on Autism Spectrum Disorder among children using Autism Treatment Evaluation Checklist after giving Individualised Homoeopathic Medicines |
16 Months Study
6 Months Enrollment
6 Months Follow up
2 Months Report Writing
2 months Data analysis
Scale to be assessed at Baseline, 3 Months and 6 Months
Statistical Analysis to be done at Baseline, 3 Months and 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
20/09/2025 |
| 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="1"
Months="4"
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
|
This study aims to know the role of Individualised Homoeopathic Medicines in the Management of Autism Spectrum Disorder in Children Aged 5 to 12 years in which 35 cases will be enrolled irrespective of gender and Autism Treatment Evaluation Checklist will be filled at Baseline 3 Month and 6 Month and outcome will be statistically assessed with Repeated measure ANOVA
|