| CTRI Number |
CTRI/2025/07/090544 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evolving Homoeopathic Approaches in ADHD: A Clinical Case-Based Study |
|
Scientific Title of Study
|
Evolving the therapeutics in the treatment of attention deficit hyperactivity disorder through clinical cases – An experimental uncontrolled 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 |
Dr Jairaj Mahaveer Patil |
| Designation |
Professor and PG Guide |
| Affiliation |
Bharatesh Homoeopathic Medical College and Hospital |
| Address |
Dept. Of Homoeopathic Materia Medica, First floor,
Bharatesh Homoeopathic Medical College and Hospital,
Sy. No 16, Basavan Kudachi Extension, Shindoli Road, Belagavi
Belgaum
KARNATAKA
591124
India |
| Phone |
9916864400 |
| Fax |
|
| Email |
drjairajmpatilmd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Moreshwar R Kulkarni |
| Designation |
Professor and PG Guide |
| Affiliation |
SJPEs Homoeopathic Medical College and Hospital |
| Address |
Dept. Of Homoeopathic Materia Medica, Ground Floor,
SJPEs Homoeopathic Medical College and Hospital, 200, E, Tararani Chowk,
Kolhapur
MAHARASHTRA
416003
India |
| Phone |
9850839483 |
| Fax |
|
| Email |
mrkulkarni242@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jairaj Mahaveer Patil |
| Designation |
Professor and PG Guide |
| Affiliation |
Bharatesh Homoeopathic Medical College and Hospital |
| Address |
Dept. Of Homoeopathic Materia Medica, First floor,
Bharatesh Homoeopathic Medical College and Hospital,
Sy. No 16, Basavan Kudachi Extension, Shindoli Road, Belagavi
Belgaum
KARNATAKA
591124
India |
| Phone |
9916864400 |
| Fax |
|
| Email |
drjairajmpatilmd@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharatesh Homoeopathic Medical College and Hospital,
Sy. No-16, Basavan Kudachi Extension, Shindoli Road, Belagavi,
Pin-591124,
Karnataka,
India |
|
|
Primary Sponsor
|
| Name |
Dr Jairaj Mahaveer Patil |
| Address |
Dept. Of Homoeopathic Materia Medica, First floor,
Bharatesh Homoeopathic Medical College and Hospital, Sy. No-16, Basavan Kudachi Extension, Shindoli Road, Belagavi, Pin-591124, Karnataka, India |
| Type of Sponsor |
Other [Self] |
|
|
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 Jairaj Mahaveer Patil |
Bharatesh Homoeopathic Medical College and Hospital, |
Dept. of Medicine, OPD No-04, Ground Floor, Sy. No-16, Basavan Kudachi Extension,
Shindoli Road, Belagavi, Karnataka, India- 591124
Belgaum
KARNATAKA |
9916864400
drjairajmpatilmd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F90||Attention-deficit hyperactivity disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homeopathic Remedy |
1) Individualized Homeopathic Remedy,
Route: Oral, Dose: 4 globules stat.
2) Non-Medicated globules,
Route: Oral, Dose: 4 globules/BD/Day/ Month for a Duration of 6 months. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects of both sexes between the age group of 5 to 15 years irrespective of their socioeconomic status shall be included under the subjects assent and parent’s informed consent.
2) All three types (Predominately hyperactive-impulsive, predominately inattentive, combined hyperactive-impulsive and inattentive) of ADHD subjects clinically diagnosed cases as per Diagnostic Statistical Manual of Mental Disorder-V (DSM-V) shall be considered for the study.
3) Subjects with baseline score equal or greater than 37 on Vanderbilt ADHD diagnostic parent rating scale (VADPRS) shall be included. |
|
| ExclusionCriteria |
| Details |
1) Subjects with Intellectual disability (Mental retardation).
2) Subjects with other mental disorders, OCD, Schizophrenia.
3) Subjects having history of any medical illness like hypothyroidism, genetic disorder and neurological disorders.
4) Subjects having congenital deformity.
5) Subjects who are on any other medications for known chronic illness like allergic conditions, systemic illness, failures of vital organs or systems as detected clinically.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome will be assessed as the change in the pre and post intervention scores as assessed using the Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS) over a period of 6 months |
Outcome will be assessed/estimated at baseline, and subsequently on a monthly basis for a duration of 6 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
20/07/2025 |
| 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="3"
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
|
This paper presents an experimental uncontrolled study aimed at evolving effective homeopathic therapeutics for treating Attention Deficit Hyperactivity Disorder (ADHD) in children aged 5-15 years. By analyzing clinical cases, the study seeks to identify reliable indications for specific homeopathic remedies that reduce ADHD symptom severity, as measured by the Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS) over six months. The research involves detailed case-taking, individualized remedy selection, and regular follow-up, with outcomes assessed through standardized rating scales. The study addresses the need for safe, alternative treatments for ADHD and aims to contribute evidence on the role of homeopathy in pediatric mental health management. |