| CTRI Number |
CTRI/2024/12/077898 [Registered on: 10/12/2024] Trial Registered Prospectively |
| Last Modified On: |
05/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Intervention using homoeopathic medicine in the management of autism spectrum disorder |
|
Scientific Title of Study
|
Role of individualized homoeopathic medicine in the management of autism spectrum disorder 3 to 18 years a prospective single arm pre post clinical study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhika Ranganathan |
| Designation |
PG scholar |
| Affiliation |
bakson homoeopathic medical college and hospital |
| Address |
Department of pediatrics ground floor G20 bakson homoeopathic medical college and hospital 36B knowledge park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
8248327239 |
| Fax |
|
| Email |
rangathannidhika@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Puneet Garg |
| Designation |
guide and HOD |
| Affiliation |
bakson homoeopathic medical college and hospital |
| Address |
Department of pediatrics ground floor G20 bakson homoeopathic medical college and hospital 36B knowledge park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9411437669 |
| Fax |
|
| Email |
drpuneetgarg18@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Garg |
| Designation |
guide and HOD |
| Affiliation |
bakson homoeopathic medical college and hospital |
| Address |
Department of pediatrics ground floor G20 bakson homoeopathic medical college and hospital 36B knowledge park 1
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9411437669 |
| Fax |
|
| Email |
drpuneetgarg18@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bakson homoeopathic medical college and hospital
36B phase 1
knowledge park I
Greater Noida
201310
Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Bakson homoeopathic medical college and hospital |
| Address |
principal office
ground floor
room number G22
Bakson homoeopathic medical college and hospital 36B phase 1 knowledge park I Greater Noida 201310
Uttar Pradesh |
| 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 Nidhika Ranganathan |
Bakson homoeopathic medical college and hospital |
out patient department (OPD)
ground floor
room no 1
36B phase 1 knowledge park I Greater Noida
201310
Gautam Buddha Nagar
UTTAR PRADESH |
8248327239
rangathannidhika@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bakson institute ethics 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 |
Homoeopathic medicine |
30 pill size
oral root of administration
centesimal scale
first dose at the time of case taking
subsequent doses according to the follow up |
| Comparator Agent |
Nil |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Participants of 3 to 18 years of age irrespective of their religion and gender
Clinically diagnosed cases of autism spectrum disorder with or without comorbidities
Participant fulfilling the criteria of ISSA scale with score between 70 to 153 70 mild autism more than 153 severe autism
participants whose parents legally authorized guardian are willing to give consent for the study
|
|
| ExclusionCriteria |
| Details |
Participants with severe systemic illness any immunocompromised condition severe psychiatric issues substance abuse and severe endocrine disorders
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 |
| Changes in the quantitative and overall score in severity of symptoms of autism spectrum disorder by the application of ISAA scale |
15 months study
6 months enrollment
6 months follow up
3 months report writing and data analysis |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/12/2024 |
| 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="3"
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 to assess the role of Homoeopathic Medicines in the treatment of Autism spectrum disorder sample size 30 prospective single arm pre post clinical trial
15 months study
ISAA scale used for assessment
scores at baseline after 3 months and after 6 months will be used for final assessment
changes in the quantitative and overall score in severity of symptoms of Autism spectrum disorder by the application of ISAA scale |