| CTRI Number |
CTRI/2024/06/069341 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy
Other (Specify) [SPEECH THERAPY] |
| Study Design |
Other |
|
Public Title of Study
|
A study to understand the role of homoeopathic medicine in treating children with speech and language disorders |
|
Scientific Title of Study
|
A Comparative Study on the Effectiveness of Homoeopathic intervention over Speech therapy in Speech and Language Disorders among Children |
| 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 Winnie Mathew |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Dept of Paediatrics Sarada Krishna Homoeopathic Medical college Kanniyakumari district
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
8921866337 |
| Fax |
|
| Email |
win.mathew7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr AL Mahadevi |
| Designation |
Assistant Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Dept of Paediatrics Sarada Krishna Homoeopathic Medical college Kanniyakumari district
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9487417921 |
| Fax |
|
| Email |
mahaiyapp338@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr AL Mahadevi |
| Designation |
Assistant Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Dept of Paediatrics Sarada Krishna Homoeopathic Medical college Kanniyakumari district
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9487417921 |
| Fax |
|
| Email |
mahaiyapp338@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari District, Tamil NÄdu 629161 |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic Medical College |
| Address |
Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari District, Tamil NÄdu 629161 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Winnie Mathew |
Sarada Krishna Homoeopathic Medical college |
room no 409, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari district
Kanniyakumari
TAMIL NADU |
8921866337
win.mathew7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sarada Krishna Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F809||Developmental disorder of speech and language, unspecified, (2) ICD-10 Condition: F801||Expressive language disorder, (3) ICD-10 Condition: F802||Mixed receptive-expressive language disorder, (4) ICD-10 Condition: F808||Other developmental disorders of speech and language, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Homoeopathic medicines of potency 200 will be repeated once in 2 weeks.
Homoeopathic medicine of 1M potency will be repeated once in every month.
Homoeopathic intercurrent remedy will be administered once only when required. |
| Comparator Agent |
Homoeopathic medicine and speech therapy. |
Weekly one session of speech therapy for 30 mins by the speech therapist along with the administration homoeopathic medicine. Homoeopathic medicines of 200 potency will be repeated once in 2 weeks, homoeopathic medicine of 1M potency will be repeated once a month. Homoeopathic intercurrent remedy will be administered once when required. |
| Comparator Agent |
Speech therapy |
Weekly one session by the speech therapist. Each session will be for 30 mins. The speech therapy techniques will be tailored according to the requirement of the patient. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Age group 3 to 15 years
Both genders
Children with speech disorders (articulation disorders and fluency disorder - stuttering) and language disorders
Children with secondary speech and language impairment
|
|
| ExclusionCriteria |
| Details |
Children with hearing impairment.
Age less than 3 years and above 15 yrs.
Children having speech and language disorders due to congenital anomalies and anatomical deficits.
Children with speech and language disorders due to changes in the structure of muscles and bones used for sound production.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the effectiveness of homoeopathic intervention in speech and language disorders.
Improvement in the speech and language assessment score once in 3 months.
|
The outcomes will be assessed once in 3 months (3rd, 6th and 9th months) during the trial period.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify the type of speech and language disorders commonly occurring in children.
To identify the etiology/ risk factors.
To study the impact of screen time.
|
1 year |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
18/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
Speech and language development are one of the important developments of a child. Disorders of speech and language can adversely affect a child’s academic, social and personal life. Speech therapy has been widely used for the improvement of speech and language but alternative complimentary ways of management has not been thoroughly studied even though its relevance in these days are high. The study aims to understand the efficacy of homoeopathic intervention in comparison with speech therapy in managing speech and language disorders in children. It also aims to identify the type of speech and language disorders commonly occurring in children, etiology/ risk factors and the impact of screen time. For the study children presenting with speech and language disorders will be screened and selected. The case taking and recording of the problem will be done in a standardized case record format. The subjects will be equally divided into 3 groups A , B & C with subjects in group A receiving only homoeopathic medicines , subjects in group B receiving only speech therapy and subjects in group C receiving both homoeopathic medicines and speech therapy. Homoeopathic intervention /medicine will be selected based on individualization and repeated according to the potency. Speech therapy and assessment of speech and language will be done by the certified speech therapists. Assessment will be done every 3 months for 3 times during the trial period for improvement by using one of the following scale specific for the type of speech and language disorder presented and the primary language spoken by the subject ; receptive- expressive emergent language test and linguistic profile test for language disorders, Malayalam articulation test and test of articulation in tamil for articulation disorders, stuttering severity instrument-4 for fluency disorder (stuttering). |