| CTRI Number |
CTRI/2025/10/095644 [Registered on: 06/10/2025] Trial Registered Prospectively |
| Last Modified On: |
06/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of predefined homeopathic medicine in the treatment of ADHD in children 3-12 years |
|
Scientific Title of Study
|
Effect Of Predefined Homeopathic Medicines In The Management Of ADHD In Children (3-12 years): A Prospective Clinic Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANWESHA MISHRA |
| 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 |
7042466246 |
| Fax |
|
| Email |
anwesha.3108@gmail.com |
|
Details of Contact Person
Scientific 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 |
|
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 Room No G22 Principal Office Ground Floor Plot No 36B Knowledge Park Phase1 Greater Noida Uttar Pradesh 201306 |
|
|
Primary Sponsor
|
| Name |
Bakson Homoeopathic Medical College And Hospital |
| Address |
Bakson Homoeopathic Medical College And Hospital Room No G22 Principal Office Ground Floor Plot No 36B Knowledge Park Phase1 Greater Noida Uttar Pradesh 201306 |
| 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 Anwesha Mishra |
Bakson Homoeopathic Medical College And Hospital |
Out Patient Department Room No 1 Ground Floor Plot No 36B Knowledge Park Phase1 Greater Noida Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH |
7042466246
anwesha.3108@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: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines |
Oral route of administration pill form 30 pill size Centicimal scale one dose after initial case taking repetition of dose according to follow up which will be every 4 weeks |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Participants aged 3 to 12 years irrespective of the gender
Clinically diagnosed cases of ADHD
Participants willing to give assent or consent by the legal guardian
Participants with secondary comorbid conditions due to ADHD will be included |
|
| ExclusionCriteria |
| Details |
Participants who are under allopathic treatment either for ADHD or other disease
Participants suffering from severe systemic illness or any immuno-compromised
condition severe psychiatric illness substance abuse and endocrine disorders
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine which among the predefined remedies are
more effective and better indicated for management of ADHD |
Enrollment of cases –6 months
Study period and follow up- 6 months.
Data analysis- 2 months
Report formation – 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the changes in ADHD symptom severity—
using the Conners’ Parent Rating Scale–Revised (CPRS-R).
|
baseline
12 weeks
24 weeks |
|
|
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)
|
17/10/2025 |
| 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 assess the effect of predefined homoeopathic medicines in the management of Attention Deficit Hyperactivity Disorder in children aged 3-12 years. Total 35 cases will be enrolled irrespective of their gender. The changes will be recorded usind Conner’s parent rating scale. Repeated Measure Anova will be used for statistical analysis at baseline 3 months and 6 months |