| CTRI Number |
CTRI/2025/05/087041 [Registered on: 16/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
MANAGING LEARNING DISABILITIES IN CHILDREN USING HOMOEOPATHIC MEDICINES |
|
Scientific Title of Study
|
A CLINICAL STUDY ON THE MANAGEMENT OF LEARNING DISABILITIES IN CHILDREN USING HOMOEOPATHIC CONSTITUTIONAL MEDICINES |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Melvin Abraham K |
| Designation |
PG Scholar |
| Affiliation |
White Memorial Homoeo Medical College and Hospital |
| Address |
Dept of Pediatrics,
White Memorial Homoeo Medical College and Hospital, Veeyanoor.PO, Kanyakumari
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9843043113 |
| Fax |
|
| Email |
melvinkrishnan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR T K NAGENDRAN |
| Designation |
PROFESSOR, HOD, DEPARTMENT OF PAEDIATRICS, WHITE MEMORIAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Affiliation |
WHITE MEMORIAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, ATTOOR |
| Address |
DEPARTMENT OF PAEDIATRICS,
WHITE MEMORIAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, ATTOOR, VEEYANOOR PO, KANYAKUMARI DISTRICT
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
8946004665 |
| Fax |
|
| Email |
drtkn1996@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR T K NAGENDRAN |
| Designation |
PROFESSOR, HOD, DEPARTMENT OF PAEDIATRICS, WHITE MEMORIAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL |
| Affiliation |
WHITE MEMORIAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, ATTOOR |
| Address |
DEPARTMENT OF PAEDIATRICS,
WHITE MEMORIAL HOMOEOPATHIC MEDICAL COLLEGE AND HOSPITAL, ATTOOR, VEEYANOOR PO, KANYAKUMARI DISTRICT
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
8946004665 |
| Fax |
|
| Email |
drtkn1996@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Department of Pediatrics, White Memorial Homoeo Medical College, Attoor |
| Address |
White Memorial Homoeo Medical College And Hospital, Attoor, Chevaracode, Veeyanoor PO, Kanyakumari District |
| 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 MELVIN ABRAHAM K |
WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
DEPARTMENT OF PAEDIATRICS, WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL, ATTOR, VEEYANOOR PO, KANYAKUMARI DISTRICT,TAMILNADU
Kanniyakumari
TAMIL NADU |
9843043113
melvinkrishnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE WHITE MEMORIAL HOMOEO MEDICAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F81||Specific developmental disorders of scholastic skills, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Children of age group 6 to 16 years old will be screened for learning disabilities and then Homoeopathic Constitutional Medicines |
| Intervention |
Homoeopathic Medicine |
Oral route of Administration for 15 days |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Children of age group of 6 to 16 years are included
Children with both sexes are included
IQ Greater than 85
Children who do not have access or cannot afford special training |
|
| ExclusionCriteria |
| Details |
Mental retardation
Children with other systemic illness
Children below 6 years and above 16 years og age
Neurological problems or Sensory impairments auditory and visual |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic improvement one month after the administration of Homoeopathic Medicine on every follow up will be assessed with the help of Wechsler Intelligence Scale for Children Version V |
Assessed Every 4 weeks to 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| After one year completion of study in every one month interval follow up will be done for symptomatic improvement with the help of Wechsler Intelligence Scale for Children version V |
1 year |
|
|
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)
|
16/07/2025 |
| 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="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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [melvinkrishnan@gmail.com].
- For how long will this data be available start date provided 06-07-2026 and end date provided 06-07-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
To study the efficacy of homoeopathic medicine in the management of learning disabilities in children. The degree of human resource development determines the economic growth and national development of a country. Thus education is the nucleus of development. A high degree of human resource development cannot be accomplished without uplifting backward students who are learning disabled, slow learners, etc. They should be able to reach their optimum level of performance. This is not possible without adequate intervention strategies. Specific learning disorder is a common but infrequently diagnosed cause of scholastic backwardness. Learning disorder is frequently co-morbid with many childhood psychiatric disorders. Homoeopathy has a vast scope in the management of learning disabilities without any adverse side effects. Hence to know the efficacy of constitutional homoeopathic medicines in learning disabilities, this study is undertaken. |