| CTRI Number |
CTRI/2024/06/069191 [Registered on: 19/06/2024] Trial Registered Prospectively |
| Last Modified On: |
17/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy
Diagnostic
Screening |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the role of bacopa monnieri mother and individulaized homoeopathic medicine in treating slow learning children |
|
Scientific Title of Study
|
Comparative Study on the Effectiveness of Bacopa monnieri Mother tincture and Individualized Homoeopathic medicine in Children with Scholastic Backwardness |
| 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 NANDHINI M |
| Designation |
PG Scholar |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Department of Paediatrics, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari District
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
8778554086 |
| Fax |
|
| Email |
moorthi3799@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr D BENCITHA HORRENCE MARY |
| Designation |
Associate Professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical College |
| Address |
Department of Paediatrics, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari District
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443064215 |
| Fax |
|
| Email |
dr.bencitha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D BENCITHA HORRENCE MARY |
| Designation |
Associate Professor |
| Affiliation |
Sarada Krishna Homeopathic Medical College |
| Address |
Department of Paediatrics, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari District
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9443064215 |
| Fax |
|
| Email |
dr.bencitha@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUITION- Sarada Krishna Homoeopathic Medical College Kulasekharam Kanyakumari District Tamilnadu 629161 |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic Medical College |
| Address |
Department of Paediatrics, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanyakumari District |
| 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 |
| DrBencitha Horrence Mary |
Sarada Krishna homoeopathic medical college |
Department of Paediatrics
Kanniyakumari
TAMIL NADU |
9443064215
dr.bencitha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sarada Krishna Homoeopathic Medical College- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
scholastic backwardness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacopa monnieri mother tincture and individulaized homoeopathic medicine |
Bacopa monnieri mother tincture administered to children below 10 years as 5gtt in 30 ml aqua BD and above 10 years as 10gtt in 30 ml aqua BD
individualized homoeopathic medicine administered according to the susceptibility of the patient
repetiition of medicine will be administered based on the improvement of the patient ,follow up assessment will be followed successively every 3 months for the period of 6 months to 1 year |
| Comparator Agent |
Individulaized homoeopathic medicine |
Individulaized Homoeopathic
medicine is selected based on symptom similarity repetition of medicine will be decided based on the improvement of patient follow up assessment will be followed successively every 3 months for the period of 6 months to 1 year |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
children age group between 6 - 18 years of age
children with IQ level between 70-85
a child was considered to have scholastic backwardness if he or she failed regularly in all subjects or had class failure in the previous years
children should be regular students attending normal schools
|
|
| ExclusionCriteria |
| Details |
children with mental retardation, specific learning disability, ADHD, anxiety disorders, depression, depression, or psychosis, conduct disorders etc. by following DSM -IV criteria
children with hearing or visual defects and with physical illness
children with preschool age group |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of Academic performance performance rating scale results before and after the administration of Bacopa monnieri mother tincture and individualized homoeopathic medicien between the two groups will be done
The clinical progression during the follow up |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Academic Performance Rating Scale results before & after the administration of Bacopa monnieri Mother tincture & Individualized Homoeopathic medicine between the two groups will be done
The clinical progression during the follow up |
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)
|
15/07/2024 |
| 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)
|
Not Yet Recruiting |
| 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
|
A selection of cases presenting with symptoms of difficulty in concentration, memory weakness, slowness of learning, lack of interest in studies, getting failure in all subjects from OPD, IPD and school health programs of Sarada Krishna Homoeopathic Medical College will be taken. Then they are allowed to undergo IQ assessment by using SEGUIN FORM BOARD TEST AND WESCHLER INTELIGENCE SCALE IQ range between 70-85 are taken into consideration. Detailed case taking is done and recorded in SKHMC standardized chronic case record format. Symptom analysis is done, and the remedies will be prescribed based upon the individuality of the patient. After erecting the totality and administering the individualized Homoeopathic remedy, the patients will be randomly categorized into 2 groups, with 30 each .Group I – The intervention for the patients will be individualized homoeopathic medicine .Group II – The intervention of the patients will be only the Bacopa monnieri mother tincture. Academic Performance Rating Scale assessment will be done for every 3months.Follow- up will be taken every month, and the pre and post results will be compared for further analysis. Follow-up analysis, repetition and dosage will be done as per the direction of the 5th and 6th edition of Organon of Medicine. Follow-up assessment will be done every month A comparative analysis of the pre and post Academic Performance Rating Scale assessment results of both the groups will be done. A comparative statistical analysis will be done. |