| CTRI Number |
CTRI/2025/11/098181 [Registered on: 28/11/2025] Trial Registered Prospectively |
| Last Modified On: |
27/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Role of Homeopathic Medicines in ADHD |
|
Scientific Title of Study
|
Effectiveness Of Individualized Homoeopathic Medicines in Attention Deficit Hyperactivity Disorder using NICHQ VANDERBILT ADHD Diagnostic Parent rating scale in children of age group 6 to 12 years |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshita khare |
| Designation |
Phd scholar |
| Affiliation |
G C Homoepathic Medical College & research Center Bakshi ka talab Parvatpur Lucknow |
| Address |
Paediatrics unit 2
G C Homoepathic Medical College & research Center Bakshi ka talab Parvatpur Lucknow
Lucknow
UTTAR PRADESH
226202
India |
| Phone |
09235343449 |
| Fax |
|
| Email |
dr.anshitakhare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonia Tuteja |
| Designation |
Professor |
| Affiliation |
Homoeopathy university jaipur Rajasthan |
| Address |
Materia medica department unit 4 ,Dr MPK Homoeopathic Medical College and hospital and Research society
Saipura sanganer Jaipur Rajasthan
Jaipur
RAJASTHAN
302029
India |
| Phone |
9530454132 |
| Fax |
|
| Email |
soniatuteja860@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aijaz Aziz sulemani |
| Designation |
Principal |
| Affiliation |
G C Homoeopathic Medical collge and Research Center |
| Address |
Medicine OPD unit 1, G C Homoepathic Medical College & research Center Bakshi ka talab Parvatpur Lucknow
Lucknow
UTTAR PRADESH
226202
India |
| Phone |
09829049721 |
| Fax |
|
| Email |
draaijaz@yahoo.com |
|
|
Source of Monetary or Material Support
|
| G C Homoeopathic Medical College and Research Center Lucknow Uttar Pradesh 226202 |
|
|
Primary Sponsor
|
| Name |
Dr Anshita khare |
| Address |
G C Homoeopathic Medical College and Research Center Lucknow Uttar Pradesh 226202 |
| 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 ANSHITA KHARE |
G C Homoeopathic Medical College and Research Center Lucknow Uttar Pradesh 226202 |
Unit-2,Paediatrics G C Homoeopathic Medical College and Research Center,Post – Indaurabagh, Vill, Chandrika Devi Rd, Bakshi Ka Talab, Parvatpur, Lucknow, Uttar Pradesh-226202
Lucknow
UTTAR PRADESH |
9235343449
dr.anshitakhare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Homoeopathy University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F901||Attention-deficit hyperactivity disorder, predominantly hyperactive type, (2) ICD-10 Condition: F900||Attention-deficit hyperactivity disorder, predominantly inattentive type, (3) ICD-10 Condition: F902||Attention-deficit hyperactivity disorder, combined type, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Effectiveness Of Individualized Homoeopathic Medicines in Attention Deficit Hyperactivity Disorder using NICHQ VANDERBILT ADHD Diagnostic Parent rating scale in children of age group 6 to 12 years. |
Effectiveness Of Individualized Homoeopathic Medicines in Attention Deficit Hyperactivity Disorder using NICHQ VANDERBILT ADHD Diagnostic Parent rating scale in children of age group 6 to 12 years.The case history was taken with holistic concept (etiological factors, mental generals, physical generals, concomitants, characteristics particulars). Diagnosis was done according to clinical presentation using DSM-4 (TR) Criteria, NICHQ Vanderbilt ADHD Diagnostic Parent Rating scale, clinical history and physical examination of patient. Then the case were analyzed and the totality were erected. After that the symptoms were evaluated. Case taking, medicine and potency selection, and follow-up was made based on the homoeopathic principles according to Organon of medicine. Repetition and change of potency and remedy were done as and when needed according to Homoeopathic principles based on Organon of medicine.All the medication needed manufactured by SBL Pvt. Ltd. will be dispensed from the college O.P.D. Pre and Post assessment was done using NICHQ Vanderbilt ADHD Diagnostic Parent Rating scale. Patients will be seen or examine by me( Dr. Anshita Khare), as homoeopathic physician.On follow up medicine will be changed or continued accordingly only after the proper evaluation of the case. Follow up of visit shall be evaluated at 2, 4, 6, and 8 weeks after the initial evaluation. At each of these visits, the subjects shall be evaluated, questioned about the effects of homoeopathic remedy. Selection of tools:Homoeopathic case taking Proforma: Standardized homoeopathic case taking format.
DSM-4(TR) Criteria will be taken for patients.
NICHQ Vanderbilt ADHD Diagnostic Parent Rating scale-Includes both teacher and parent reported symptoms; VADTRS and VADPRS. Other conditions such as Opposite Defiant Disorder and Conduct Disorder and a sub scale for anxiety and depression are included in this scale.Total duration of the study is 18 months. |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Both sexes are included. Children between 6 -12 years of age.All 3 types of diagnosed cases of ADHD as per DSM-4(TR) Criteria. Patient having no other complicated systemic illness. |
|
| ExclusionCriteria |
| Details |
Patient who have other behavioral problems such as Oppositional behavioral disorder, conduct disorder,Anxiety and Depression. Patient’s already diagnosed and taking treatment from conventional system of medicine. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Individualized Homoeopathic medicines will prove effective in the management of ADHD. |
IndividualizedHomoeopathic medicines will prove effective in the management of ADHD. within 12 months of medicine intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The study will determine whether the quality of life of patients suffering from ADHD can be improved by using Individualised homoeopathic medicine.If the results would be positive then a certain group of medicines can be found out which would frequently prove effective in ADHD. |
12 weeks to 24 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/12/2025 |
| 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="6"
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 is a prospective, interventional study which aims to asses efficacy of individualized homoeopathic medicine in attention deficit hyperactivity disorder.Individualized homoeopathic medicine will be prescribed in decimal/ centesimal/ millesimal scale after detailed case taking and repertorization. ADHD is characterised by inattentiveness,including increased distractibility and difficulty sustaining attention;poor impulse control and decrease self inhibitory and motor over activity and motor restlessness.It is one of the most common behavioral disorder affecting children.ADHD is variable in its appearance and nature of symptoms. That is why approaching it clinically is a challenging task for the physicians. The first appearance of this condition in DSM-II (1968) used the term hyperkinetic reaction of childhood or adolescence. Whereas in 1980, the DSM-III recognized two sub- types of a syndrome of attention deficit disorder (ADD) – ADD with hyperactivity and ADD without hyperactivity. In 1987, the DSM-III was reconstituted (DSM-III-R) and the term Attention-Deficit Hyperactivity Disorder (ADHD) was coined.[2]Finally, in 1994, the DSM-IV recognized three subtypes of the syndrome: ADHD inattentive type, ADHD-hyperactive-impulsive type, and ADHD-combined type.The case history was taken with holistic concept (etiological factors, mental generals, physical generals, concomitants, characteristics particulars). Diagnosis was done according to clinical presentation using DSM-4 (TR) Criteria, NICHQ Vanderbilt ADHD Diagnostic Parent Rating scale, clinical history and physical examination of patient. Then the case were analyzed and the totality were erected. After that the symptoms were evaluated. Case taking, medicine and potency selection, and follow-up was made based on the homoeopathic principles according to Organon of medicine. Repetition and change of potency and remedy were done as and when needed according to Homoeopathic principles based on Organon of medicine. |