| CTRI Number |
CTRI/2025/09/095066 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homoeopathy in treatment of Behavioral problems in Intellectual Disability |
|
Scientific Title of Study
|
Effect of Individualised Homoeopathic Medicines in the Management of Behavioral Problems in Children (5-17 years) with Disorders of Intellectual Development -A Prospective Single Arm Clinical Trial |
| 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 Kanak Singhal |
| Designation |
PG Scholar |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G 20
Department of Paediatrics Ground floor
36 B Knowledge Park Phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9313189740 |
| Fax |
|
| Email |
drkanaksinghal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Kumar |
| Designation |
Guide and Associate Professor |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G 20
Department of Paediatrics Ground floor
36 B Knowledge Park Phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9818216191 |
| Fax |
|
| Email |
dr.ajaybhati28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Puneet Garg |
| Designation |
Professor and HOD |
| Affiliation |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room no G 20
Department of Paediatrics Ground floor
36 B Knowledge Park Phase 1 Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9411437669 |
| Fax |
|
| Email |
drpuneetgarg18@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Bakson Homoeopathic Medical College and Hospital 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh 201306 |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College and Hospital |
| Address |
Room No G 22
Principal Office
Ground Floor
36 B Knowledge Park Phase 1 Greater Noida |
| 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 |
| Dr Kanak Singhal |
Bakson Homoeopathic Medical College and Hospital |
Out Patient Department Room No 1 Ground Floor 36 B Knowledge Park Phase 1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
9313189740
drkanaksinghal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Bakson Homoeopathic Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F70-F79||Intellectual disabilities, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicine |
Oral route of administration
30 pill size Centesimal Scale First dose after case taking Repetition of dose according to follow up every 4 weeks |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of Disorders of Intellectual Development
Age 5 to 17 years
Both males and females |
|
| ExclusionCriteria |
| Details |
Participants with severe systemic illness.
Participants with history of severe and frequent violent exacerbations needing allopathic medication and hospitalization.
Participants with uncontrolled or unstable psychiatric conditions. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessing the Effect of Individualized Homoeopathic medicines in the management of Behavioral problems among children with Disorders of Intellectual Development by using BASIC MR scale |
16 Months Study
6 Months Enrollment
6 Months Follow up
2 Months Assessment and Data Analysis
2 Months Report Writing
Scale to be assessed at baseline at 3 Month and at 6 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
29/09/2025 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
This study aims to know the role of Individualised Homoeopathic Medicines in the Management of Behavioral Problems in Children Aged 5 to 17 years with Disorders of Intellectual Development 35 cases will be enrolled irrespective of gender BASIC MR Scale will be filled at Baseline 3 months and 6 months Outcome will be statistically assessed with Repeated Measure ANOVA |