| CTRI Number |
CTRI/2025/09/094691 [Registered on: 12/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Homeopathy |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the effectiveness of homeopathy versus art therapy in treating Attention Deficit Hyperactive Disorder(Impulsive,inability to focus,hyperactive) |
|
Scientific Title of Study
|
A comparative study on the efficacy of Homoeopathic constitutional medicine versus art therapy in managing Attention Deficit Hyperactive Disorder |
| 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 SNEHA S SHAJI |
| Designation |
Junior resident department of peadiatrics |
| Affiliation |
White memorial homeopathic medical college |
| Address |
Department of Pediatrics ,
White memorial homeopathic medical college and hospital
Attoor Kannyiakumari district
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9188635189 |
| Fax |
|
| Email |
drsnehasabithashaji@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JUDIN STEPHENSON |
| Designation |
Associate Professor |
| Affiliation |
White memorial homeopathic medical college and hospital |
| Address |
Department of Pediatrics,
White Memorial Homoeo Medical College and Hospital,
Attoor, Kanyakumari District.
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
9538484284 |
| Fax |
|
| Email |
judzon3535@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. SNEHA S SHAJI |
| Designation |
Junior resident,Department of peadiatrics |
| Affiliation |
White memorial homeopathic medical college and hospital |
| Address |
Department of Peadiatrics,
White Memorial Homoeopathic Medical College and Hospital, Attoor, Kanuakumari District.
Kanniyakumari
TAMIL NADU
629177
India |
| Phone |
91886 35189 |
| Fax |
|
| Email |
drsnehasabithashaji@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of peadiatrics,
White Memorial Homeo Medical College and Hospital Attoor Kannyiakumari Tamilnadu 629177 India |
|
|
Primary Sponsor
|
| Name |
White memorial homeo medical college and hospital |
| Address |
Attoor,Veeyanoor, Kannyiakumari District, Tamilnadu. 629177
PIN: 629177 |
| 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 SNEHA S SHAJI |
White memorial homeopathic medical college and hospital |
Departnment of peadiatrics White Memorial Homeo Medical College and Hospital, Attoor.
Kanniyakumari
TAMIL NADU |
9188635189
drsnehasabithashaji@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| White Memorial Homoeo 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 |
| Comparator Agent |
1. HOMEOPATHY
2. ART THERAPY
3 COMPILED |
ONE YEAR |
| Intervention |
HOMEOPATHY ,ART THERAPY |
HOMEOPATHY ,ART THERAPY
ONE YEAR |
| Comparator Agent |
HOMOEOPATHY AND ART THERAPY |
HOMOEOPATHY ONLY
ART THERAPY ONLY
COMPAINED |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
1.The children qualifying Vanderbilt Parental Rating Scale.
2. Must score a 2 or 3 on 6 out of 9 items on questions 1-18. |
|
| ExclusionCriteria |
| Details |
1.Autism spectrum disorder (ASD) (unless ADHD symptoms are clearly present and separate) Disorders.
2.Substance abuse
3.Major psychiatric disorders or other neurological conditions.
•Intellectual Disability
•Other systemic conditions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Each case will be assessed using vanderbilt parent rating scale,case will be followed for 1 year and assessment monthly once |
Each case will be assessed using vanderbilt parent rating scale,case will be followed for 1 year and assessment monthly once |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsnehasabithashaji@gmail.com].
- For how long will this data be available start date provided 04-03-2026 and end date provided 04-03-2031?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
objectives:To assess the effectiveness of Homoeopathic constitutional medicines combined with Art therapy in the management of ADHD in children To assess the impact of each intervention on behavioral, emotional and social functioning in children with ADHD AIM To compare the effectiveness of homeopathic constitutional medicine and art therapy in managing ADHD METHODOLOGY: This study is designed as a comparative, before-and-after interventional trial with a control group, conducted over a minimum duration of one year.The study focuses on measuring changes in ADHD symptomatology across three distinct treatment groups using standardized tools. A purposive sampling technique will be employed to select participants who meet the defined inclusion and exclusion criteria. A minimum of 60 cases will be enrolled and equally distributed across three groups. Participants will be selected through screening conducted at school health programs, Outpatient Departments (OPD), Inpatient Departments (IPD), and Peripheral Health Centers affiliated with White Memorial Homoeo Medical College & Hospital (WMHMC). Each participant will receive intervention based on their group allocation: • Group 1 (Homeopathy only): Individualized remedy selection and treatment based on classical Homoeopathic principles, including totality of symptoms, miasmatic background, and repertorization. • Group 2 (Art Therapy only): Mandala colouring sessions inspired by validated therapeutic models. • Group 3 (Homoeopathy + Art Therapy): Integration of both the above approaches concurrently. • Cognitive Behavioral Therapy is common for all the three groups. • Each case will be evaluated by me using structured interviews with affected children along with parents/guardians using WHMC case record and Vanderbilt parent rating scale. • Participants will be monitored for 6 to 12 months with monthly follow-ups. • Assessments using the Vanderbilt Parent Rating Scale will track symptom progression. • Data will be collected at each visit and recorded systematically. . |