| CTRI Number |
CTRI/2024/09/073265 [Registered on: 03/09/2024] Trial Registered Prospectively |
| Last Modified On: |
25/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Homoeoepathic management of Maladaptive Behaviors in Children with Autism Spectrum |
|
Scientific Title of Study
|
Effectiveness Of Individualized Homoeopathic medicines in reducing Maladaptive behaviors of Children with Autism Spectrum Disorder |
| 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 Sreelekshmi P R |
| Designation |
Postgraduate Scholar,Department Of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram(P.O),
Kottayam,686532,
Depatment of Psychiatry,
Room No - 48
Kottayam
KERALA
686532
India |
| Phone |
94946377789 |
| Fax |
|
| Email |
vachusree100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrMGnnanaprakasham |
| Designation |
Associate Professor Department Of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
National Homoeopathy Research Institute In Mental Health,Sachivothamapuram (P.O),Kurichy,Kottayam-686532,
Department of Psychiatry,
Room No - 48
Kottayam
KERALA
686532
India |
| Phone |
9444701176 |
| Fax |
|
| Email |
drgprakashpsy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrMGnnanaprakasham |
| Designation |
Associate Professor Department Of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute In Mental Health |
| Address |
National Homoeopathy Research Institute In Mental Health,Sachivothamapuram (P.O),Kurichy
Kottayam,686532,
Department of Psychiatry,
Room No - 48
Kottayam
KERALA
686532
India |
| Phone |
9444701176 |
| Fax |
|
| Email |
drgprakashpsy@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homeopathy Research Institute In Mental Health
Sachivothamapuram P.O
Kottayam,686532
Kerala
India |
|
|
Primary Sponsor
|
| Name |
Dr.Sreelekshmi P.R |
| Address |
National Homoeopathy Research Institute In Mental Health,Sachivothamapuram(P.O),Kurichy,Kottayam,Kerala,686532,India |
| 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 Sreelekshmi PR |
National Homoeopathy Research Institute In Mental Health |
outpatient department (OPD), in patient department (IPD), special camps and
peripheral units of National Homoeopathy Research Institute in Mental Health Kottayam.
Kottayam
KERALA |
9496377789
vachusree100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee,National Homoeopathic Research Institute In Mental Health |
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 |
Individualized Homoeopathic Medicines |
The selection of medicine will be
based on homoeopathic principles. Appropriate individualized medicine will be given. The medicine potency ranging from 30C to 1m will be given 4-6 pills of number 30 in size,dose and freequency repetition will be according to severity of symptoms. If no change at all the case shall be retaken and another appropriate remedy will be
prescribed. If any acute complaint arises, current acute totality will be taken and the most
suitable remedy will be provided |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
1.Cases diagnosed as Childhood Autism as per DSM-V Criteria.
2.Children in the age group of 3 to 14 years
3.Children of any gender
3.Children with AMBS score greater than 155 |
|
| ExclusionCriteria |
| Details |
1.Children with ADHD, ODD, ID and other childhood behavioral disorders
2.Children with congenital disorders and other serious medical illness
3. Children with AMBS score 284 and above |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the effectiveness of individualized homoeopathic medicines in reducing the
maladaptive behaviors in children with autism spectrum disorder (ASD) using Autism
Maladaptive Behavior Scale (AMBS). |
every month till the conclusion of study(12th month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the most predominant maladaptive behaviors presented in the study using AMBS scale. |
every month till the conclusion of study(12th month) |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
06/09/2024 |
| 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="6"
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
is Effectiveness Of Individualized Homoeopathic Medicines In Reducing
Maladaptive Behaviors Of Children With Autism Spectrum Disorder that will be conducted in outpatient department
(OPD), in patient department (IPD), special camps and peripheral units of
National Homoeopathic Research Institute in Mental Health (NHRIMH) Kottayam.
The primary outcome measures will be to determine the effectiveness of
individualized homoeopathic medicines in reducing the maladaptive behaviors in
children with autism spectrum disorder (ASD) using Autism Maladaptive Behavior
Scale (AMBS). The secondary outcomes will be to compare the most predominant
maladaptive behaviors presented in the study using AMBS scale.
|