| CTRI Number |
CTRI/2023/03/050761 [Registered on: 16/03/2023] Trial Registered Prospectively |
| Last Modified On: |
16/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
The role of homoeopathic medicines in management of specific learning disability in children. |
|
Scientific Title of Study
|
The role of homoeopathic medicines in management of specific developmental disorder of scholastic skills in children. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meha |
| Designation |
MD, PGR ( post graduate resident) |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,Jaipur |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,10-A Sitapura Industrial Area, Tonk Road, Goner Road, Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
7206122063 |
| Fax |
|
| Email |
mehagoury@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swarupanda Sarkar |
| Designation |
Associate professor,Department of Psychiatry |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,Jaipur |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,10-A Sitapura Industrial Area, Tonk Road, Goner Road, Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9166653767 |
| Fax |
|
| Email |
drsarkarhomoeopathy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swarupanda Sarkar |
| Designation |
Associate professor,Department of Psychiatry |
| Affiliation |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,Jaipur |
| Address |
Swasthya Kalyan Homoeopathic Medical College and Research Centre,10-A Sitapura Industrial Area, Tonk Road, Goner Road, Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302022
India |
| Phone |
9166653767 |
| Fax |
|
| Email |
drsarkarhomoeopathy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swasthya Kalyan Homoeopathic Medical College and Research Centre,10-A, Sitapura Institutional Area, Tonk Road, Goner Road, Sitapura Industrial Area, Sitapura,Jaipur,Rajasthan,302022 |
|
|
Primary Sponsor
|
| Name |
Swasthya Kalyan Homoeopathic Medical College And Research Centre |
| Address |
Swasthya Kalyan Homoeopathic Medical College And Research Centre, 10-A, Sitapura Institutinal Area, Tonk Road, Goner Road, Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan |
| 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 |
| Meha |
Swasthya Kalyan Homoeopathic Medical College And Research Centre |
room no 222, Department of Psychiatry,Swasthya Kalyan Homoeopathic Medical College And Research Centre, 10-A, Sitapura Institutional Area, Tonk Road, Goner Road, Sitapura Industrial Area, Sitapura, Jaipur, Rajasthan 302022 ·
Jaipur
RAJASTHAN |
7206122063
mehagoury@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SKHMCIEC |
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 |
Homeopathic medicines |
2/UA/HPM/2011,oral route, doses and frequency will be according to the susceptibility of patient. The duration of intervention will be 6 months. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed cases of specific developmental disorder of scholastic skills.
|
|
| ExclusionCriteria |
| Details |
Children with advanced pathological illness who need emergency care |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
informal assessment, regular follow-up assessment, assessment by class teacher,
academic performance marks |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to formulate the homoeopathic remedy profile for management of specific developmental disorders of scholastic skills in children. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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)
|
24/03/2023 |
| 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
|
This study is a interventional and non blind to see the efficacy of homoeopathic medicines in the management of specific developmental disorders of scholastic skills in children. the study will be conducted at Swasthya Kalyan Homoeopathic Medical College and Research Centre, Jaipur. The primary outcome measures will be informal assessment, regular follow-up assessment, assessment by class teacher, academic performance marks. It will be conducted for 1 year. The Objectives are to assess the changes after homoeopathic intervention to the children with specific developmental disorder of scholastic skills. |