| CTRI Number |
CTRI/2022/05/042710 [Registered on: 20/05/2022] Trial Registered Prospectively |
| Last Modified On: |
19/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of Homoeopathy in the Management of Learning Disability |
|
Scientific Title of Study
|
Usefulness of Individualized Homoeopathic Medicine In Management of Learning Disability by Using Cognitive Retraining Program – An Open Label Double Arm Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not Applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Chaudhary |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Department of Psychiatry
Room No G 20
Ground Floor
36B Knowledge Park I
Greater Noida
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9899174015 |
| Fax |
|
| Email |
sakshichaudhary752@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kathika Chattopadhyay |
| Designation |
HOD & Guide |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Department of Psychiatry
Room No G 20
Ground Floor
36B Knowledge Park I
Greater Noida
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9910860193 |
| Fax |
|
| Email |
dr.kathika@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kathika Chattopadhyay |
| Designation |
HOD & Guide |
| Affiliation |
Bakson Homoeopathic Medical College & Hospital |
| Address |
Department of Psychiatry
Room No G 20
Ground Floor
36B Knowledge Park I
Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9910860193 |
| Fax |
|
| Email |
dr.kathika@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College & Hospital |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College Hospital |
| Address |
G 22
Ground Floor
36 B
Knowledge Park I
Greater Noida
Gautam Buddha Nagar |
| 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 |
| Sakshi Chaudhary |
Gautam Buddha University |
Peripheral Outpatient Department Department of Psychology & Mental Health
Gate No 5
Yamuna Expressway
Gautam Buddha Nagar
Gautam Buddha Nagar
UTTAR PRADESH |
9899174015
sakshichaudhary752@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Gautam Buddha University |
Approved |
| Institutional Ethical Committee, Bakson Homoeopathic Medical College & 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 |
Group B- Placebo |
Group B- Placebo
Oral Route of administration Globule Form 30 Pill Size Centesimal Scale
Follow up every 15 days.
Placebo will be repeated in every follow up. |
| Intervention |
Homoepathic Medicine
|
Group A- Homoeoapthic Medicine
Oral Route of administration
Globule Form
30 Pill Size
Centesimal Scale
Follow up every 15 days. repetition of dose according to follow up |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
11.00 Year(s) |
| Gender |
Both |
| Details |
1. Children had at least one type of LD diagnosed according to diagnostic criteria given in DSM 5
2. Age group - primary school children (5 yrs -11 yrs)
Children of both sexes.
3. Children going to or attending the school regularly.
Follow up of atleast 3 month consider in study.
Who agreed to give consent for the study
|
|
| ExclusionCriteria |
| Details |
1. Patient with other psychiatric illnesses like ADHD, ID, depression, schizophrenia etc.
2. Learning difficulties due to neurological or sensory disorder (like traumatic brain injury, hearing impairment, vision impairment, spinal cord disorder etc.)
3. Children with lack of educational inputs as causes of learning difficulty
4. Patient with other systemic disorders like SLE etc.
5. Children suffering from Seizure, we cannot provide cognitive training program to those children.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Symptomatic score should reduce in scoring on DTLD scale to show improvement. |
5 months of enrollment
6 months of treatment and Follow up
1 month analysis
total 12 months
DTLD scoring done at baseline, 3rd month and 6th month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
23/05/2022 |
| 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
|
the aim of the study is to assess the role of Homoeopathy in LD DTLD scale will be used group A- Homoeopathy Group B- Placebo
|