| CTRI Number |
CTRI/2025/10/095577 [Registered on: 03/10/2025] Trial Registered Prospectively |
| Last Modified On: |
02/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Homoeopathic Management of children with Autism . |
|
Scientific Title of Study
|
Individualized Homoeopathic Medicines in the Management of children with Autism Spectrum Disorder - A Retrospective 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 R Bhuvaneswari |
| Designation |
Research officer (Hom.) / S-3 |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
Room No. 48,
Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Kottayam
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Bhuvaneswari |
| Designation |
Research officer (Hom.) / S-3 |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
Room No. 48,
Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Kottayam
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Bhuvaneswari |
| Designation |
Research officer (Hom.) / S-3 |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
Room No. 48,
Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Kottayam
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram,
Kurichy,
Kottayam.
686532 |
|
|
Primary Sponsor
|
| Name |
Dr R Bhuvaneswari |
| Address |
Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Kottayam |
| Type of Sponsor |
Other [Self] |
|
|
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 R Bhuvaneswari |
National Homoeopathy Research Institute in Mental Health |
Room No. 48,
Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health
Kottayam
KERALA |
8281475541
dr.r.bhuvaneswari2021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NHRIMH INSTITUTIONAL ETHICAL COMMITTEE |
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 |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Participants diagnosed with Autism Spectrum Disorder as per the DSM-5 criteria.
2. Participants with a minimum follow-up of six months. |
|
| ExclusionCriteria |
| Details |
1. Participants diagnosed with any organic disorders.
2. Participants with any other serious medical illness and multiple disabilities. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the outcomes of individualized Homoeopathic management of ASD using the appropriate assessment scales. |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify the frequently indicated Homoeopathic medicines in the effective management of children with ASD. |
One year |
|
|
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)
|
20/10/2025 |
| 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="0"
Months="8"
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 retrospective observational cohort study aims
to evaluate the outcomes of individualized homoeopathic treatment in children
with Autism Spectrum Disorder (ASD) using standardized assessment tools. The
study will be conducted at the National Homoeopathy Research Institute in
Mental Health, Kottayam, by analyzing case records of approximately 30 children
aged 3–17 years, diagnosed with ASD as per DSM-5 criteria, who received
individualized homoeopathic treatment and had a minimum of one year of
follow-up between 2019 and 2025. Treatment outcomes will be assessed using the
Indian Scale for Assessment of Autism (ISAA) and the Autism Treatment
Evaluation Checklist (ATEC), with the primary outcome being the mean change in
ISAA total score from baseline to 12 months. Statistical analysis will include
descriptive and inferential methods to evaluate treatment effectiveness and
identify frequently indicated medicines. The study seeks to generate
evidence-based insights into the role of individualized homoeopathy in the
management of ASD. |