| CTRI Number |
CTRI/2025/08/093851 [Registered on: 28/08/2025] Trial Registered Prospectively |
| Last Modified On: |
28/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Adjuvant Homoeopathic treatment in the management of sensory patterns of Autism Spectrum Disorder |
|
Scientific Title of Study
|
Explorative study of adjuvant Homoeopathic treatment as part of standard treatment in the management of sensory patterns of Autism Spectrum Disorder
(ASD) in children aged 3 to 12 years- Randomized controlled 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 Sheikh Tanvir Abdul Hamid |
| Designation |
Assistant Professor, Department of Homoeopathic Psychiatry |
| Affiliation |
Assistant Professor, Department of Homoeopathic Psychiatry |
| Address |
Dr M L Dhawale Memorial Homoeopathic Institute, Opp. S.T. Workshop, Palghar - Boisar Road, Palghar
Palghar
MAHARASHTRA
404401
India |
| Phone |
9967710966 |
| Fax |
|
| Email |
tanvirsheikh43@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahendra Hariram Gaushal |
| Designation |
Principal; Professor and Head, Department of Psychiatry |
| Affiliation |
Principal; Professor and Head, Department of Psychiatry |
| Address |
Sonajirao Kshirsagar Homoeopathic Medical College,
Vidhya Nagar (W), College Road (W), Beed
Bid
MAHARASHTRA
431 122
India |
| Phone |
9822852735 |
| Fax |
|
| Email |
kaizen.mg@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahendra Hariram Gaushal |
| Designation |
Principal; Professor and Head, Department of Psychiatry |
| Affiliation |
Principal; Professor and Head, Department of Psychiatry |
| Address |
Sonajirao Kshirsagar Homoeopathic Medical College,
Vidhya Nagar (W), College Road (W), Beed
Bid
MAHARASHTRA
431 122
India |
| Phone |
9822852735 |
| Fax |
|
| Email |
kaizen.mg@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr M L Dhawale Memorial Homoeopathic Institute |
| Sonjirao Kshirsagar Homoeopahic Medical College |
|
|
Primary Sponsor
|
| Name |
Dr M L Dhawale Memorial Homoeopathic Institute |
| Address |
Opp. S.T. Workshop, Palghar - Boisar Road, Palghar- 404401 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Sonajirao Kshirsagar Homoeopathic Medical College |
Sonajirao Kshirsagar Homoeopathic Medical College,
Vidhya Nagar (W) , College Road (W),
Beed-431 122. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sheikh Tanvir Abdul Hamid |
Dr M L Dhawale Memorial Homoeopathic Institute |
Dr M L Dhawale Memorial Homoeopathic Institute, Opp. S.T. Workshop, Palghar -Boisar Road, Palghar- 404401
Palghar
MAHARASHTRA |
9967710966
tanvirsheikh43@gmail.com |
| Dr Sheikh Tanvir Abdul Hamid |
Sonajirao Kshirsagar Homoeopathic Medical College |
Vidhya Nagar (W), College Road (W), Beed- 431122
Bid
MAHARASHTRA |
9967710966
tanvirsheikh43@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Dr M L Dhawale Memorial Homoeopathic Institite |
Approved |
| Sonajirao Kshirsagar 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 |
Homoeopathic treatment |
The indicated homoeopathic medicine will be decided based on the signs and symptoms. it will be given to the study group as an adjuvant along with standard treatment. |
| Comparator Agent |
occupational therapy, and if needed speech therapy |
Standard treatment for autism spectrum disorder will be given to study and control group |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children diagnosed with ASD as per DSM 5
Children diagnosed with ASD on (Indian Scale for Assessment of Autism) ISAA
|
|
| ExclusionCriteria |
| Details |
Children suffering from chronic infections like tuberculosis, HIV
Cases of severe autism as assessed on ISAA
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| scores on Autism spectrum evaluation checklist and Sensory Assessment checklist |
3 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing the improvement of study with control froup |
3 years |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2 |
|
Date of First Enrollment (India)
|
12/09/2025 |
| 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="3"
Months="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Response (Others) - NIL
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 24-01-2028 and end date provided 24-09-2031?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Explorative
study of adjuvant Homoeopathic treatment as part of standard treatment in the
management of sensory patterns of Autism Spectrum Disorder (ASD) in children
aged 3 to 12 years- Randomized controlled study
Primary
objective To explore the role of adjuvant Homoeopathic treatment as part of
standard treatment in the management of sensory patterns of Autism Spectrum
Disorder (ASD) in children aged 3 to 12 years
Secondary
objective 1 To compare the improvement in the sensory patterns of the patients
prescribed adjuvant Homoeopathic treatment with the control group.
Secondary
objective 2 To study the various sensory patterns of ASD and the indications of
the Homoeopathic remedy for the same
Secondary
objective 3 To explore the action of Homoeopathic treatment on the reduction of
the intensity of the sensory patterns as assessed on the Sensory Assessment
Checklist
Primary research question Does adjuvant
Homoeopathic treatment as part of standard treatment help in the management of
sensory patterns of Autism Spectrum Disorder (ASD) in children aged 3 to 12
years
Null Hypothesis Adjuvant Homoeopathic treatment does not improve the sensory patterns of
autistic children better than the standard treatment, as reflected in the
reduction in the scores measured on the Sensory Assessment Checklist
Alternate Hypothesis Adjuvant Homoeopathic
treatment can improve the sensory patterns of autistic children better as compared
to the standard treatment, as reflected in the reduction in the scores measured
on the Sensory Assessment Checklist
The study group as well as control group will
be given standard line of treatment which includes occupational therapy,
homoeopathy will be given homoeopathy as well. The on-going standard treatment
(if already been given before enrolling in the study) will not be disturbed.
Scales will be applied before the study, after 3 months and after 3 months.
Patients in the control group will be assessed after 3 months for need of any
medicinal intervention if they no change with the therapies or symptoms are
distressing, then they will be given homoeopathic treatment
|