| CTRI Number |
CTRI/2022/09/045602 [Registered on: 16/09/2022] Trial Registered Prospectively |
| Last Modified On: |
15/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical study on the efficacy of homoeopathic management of learning disabilities in school going children |
|
Scientific Title of Study
|
A clinical study on the efficacy of homoeopathic management of learning disabilities in school going children |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishali Khobragade |
| Designation |
Professor |
| Affiliation |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8149204885 |
| Fax |
|
| Email |
vaishali.khobragade@dpu.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rita Sangtani |
| Designation |
Professor |
| Affiliation |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9960834124 |
| Fax |
|
| Email |
rita.sangtani@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vaishali Khobragade |
| Designation |
Professor |
| Affiliation |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8149204885 |
| Fax |
|
| Email |
vaishali.khobragade@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune |
|
|
Primary Sponsor
|
| Name |
Dr Vaishali Khobragade |
| Address |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune |
| 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 Vaishali Khobragade |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune |
Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, Pimpri, Pune
Pune
MAHARASHTRA |
8149204885
vaishali.khobragade@dpu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.D.Y.Patil Homoeopathic Medical College and Research Centre, pImpri, Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70||Mild intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathy and remedial education |
Homoeopathy and remedial education for children of learning disabilities, follow up after 1 month and study duration is 12 months |
| Comparator Agent |
Placebo with remedial measures |
Placebo with remedial measures for the children of learning disabilities, follow up after 1 month and study duration is 12 months |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
Children with learning disabilities of age group from 6– 10 years of both the sex |
|
| ExclusionCriteria |
| Details |
Children below 6 years and above 10years of age, children with congenital, neurological problems like Autism, Mental retardation, children with visual or hearing impairment, Children of unwilling parents.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and document the evidence based efficacy of homoeopathic medicines in the management of Learning Disability. |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To ascertain the role of homoeopathic medicines and verify their characteristic symptoms in the management of Learning Disability
To assess the level of academic performance of children with specific learning disabilities on Specific Learning Disability: Comprehensive Diagnostic Battery (Mehta & Sagar,2014)
To find out the prevalence of Learning disability in Male and Female students.
|
1 month |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
19/09/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A clinical study on the efficacy of homoeopathic management of learning disabilities in school going children
It will be a randomized control clinical trial of 100 school going children with learning disabilities in Group I and Group II Group 1: The indicated homoeopathic medicine will be administered with remedial education to this group Group 2: Placebo and remedial education will be administered to this group Pre and post treatment assessment will be done The inference will be made after comparison between the two groups The result will be presented on the basis of data obtained from this study. |