CTRI Number |
CTRI/2025/06/089432 [Registered on: 24/06/2025] Trial Registered Prospectively |
Last Modified On: |
23/06/2025 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Homeopathy |
Study Design |
Single Arm Study |
Public Title of Study
|
Homoeopathic Management for Attention Deficit/Hyperactivity Disorder Children. |
Scientific Title of Study
|
Effectiveness of individualised homoeopathic medicine on executive function deficits in attention deficit/hyperactivity disorder children – a single arm, prospective 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 DELPHY VARGHESE |
Designation |
Post Graduate Scholar, Dept of Psychiatry |
Affiliation |
National Homoeopathic Research Institute in Mental Health, Kottayam. |
Address |
Room no - 48, Psychiatry Department, National Homoeopathic Research Institute in Mental Health, Sachivothamapuram P.O, Kurichy, Kottayam-686532 Kerala, India.
Kottayam KERALA 686532 India |
Phone |
9496289055 |
Fax |
|
Email |
delphyvarghesemala@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr R Bhuvaneswari |
Designation |
Professor and Head Of Department , Department Of Psychiatry. |
Affiliation |
National Homoeopathic Research Institute in Mental Health, Kottayam. |
Address |
Room no - 106, Psychiatry Department, National Homoeopathic Research Institute in Mental Health, Sachivothamapuram P.O, Kurichy, Kottayam-686532 Kerala, India.
Kottayam KERALA 686532 India |
Phone |
8281475541 |
Fax |
|
Email |
dr.bhuvaneswarir@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr R Bhuvaneswari |
Designation |
Professor and Head Of Department , Department Of Psychiatry. |
Affiliation |
National Homoeopathic Research Institute in Mental Health, Kottayam. |
Address |
Room no - 106, Psychiatry Department, National Homoeopathic Research Institute in Mental Health, Sachivothamapuram P.O, Kurichy, Kottayam-686532 Kerala, India.
Kottayam KERALA 686532 India |
Phone |
8281475541 |
Fax |
|
Email |
dr.bhuvaneswarir@gmail.com |
|
Source of Monetary or Material Support
|
National Homoeopathic Research Institute in Mental Health, Kottayam, Sachivothamapuram P.O, Kurichy, Kottayam-686532 Kerala, India. |
|
Primary Sponsor
|
Name |
Dr. DELPHY VARGHESE |
Address |
National Homoeopathic Research Institute in Mental Health, Sachivothamapuram P.O, Kurichy, Kottayam, kerala-686532,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 DELPHY VARGHESE |
National Homoeopathy Research Institute in Mental Health. |
Room no - 48 OPD, IPD, Peripheral camps of Department of Psychiatry, National Homoeopathy Research Institute in Mental Health, Kottayam, Sachivothamapuram P.O, Kurichy, Kottayam-686532, Kerala, India. Kottayam KERALA |
9496289055
delphyvarghesemala@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee -National Homoeopathic Research Institute in Mental Health, Kottayam. |
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 |
Individualised Homoeopathic Medicines |
After enrollment the case will be repertorised. Appropriate potentized Individualised Homoeopathic Medicine will be administered in minimum dose in appropriate potency according to the need of the case. Medicine is administered orally. Repetition will be done when improvement comes to a standstill in a higher potency of the same medicine and if the medicine is not found to be effective the case will be retaken then another appropriate medicine is given. The above homoeopathic intervention will be given for a period of 12 months. |
Comparator Agent |
NIL |
NIL |
|
Inclusion Criteria
|
Age From |
6.00 Year(s) |
Age To |
12.00 Year(s) |
Gender |
Both |
Details |
1.Children aged 6-12 yrs who diagnosed as ADHD by DSM 5 Criteria.
2.Participant having more than 13 score in any domain of ADHD in Snap IV scale.
3.Participants willing to send consent, In case of Child- Parental consent also required. |
|
ExclusionCriteria |
Details |
1. Children suffering from other childhood psychiatric illness (like Intellectual
Disability, Autism spectrum disorders, Learning Disability)
2. Children with medical conditions ( Neurological disorders like Epilepsy, Cerebral
palsy, etc) |
|
Method of Generating Random Sequence
|
Not Applicable |
Method of Concealment
|
Not Applicable |
Blinding/Masking
|
Open Label |
Primary Outcome
|
Outcome |
TimePoints |
Reduction in CHEXI scale scores Pre and Post treatment. |
Every 6 months from baseline till the conclusion of study(12 months) |
|
Secondary Outcome
|
Outcome |
TimePoints |
Reduction of overall ADHD symptoms measured by Snap IV scale. |
Every 6 months from baseline till the conclusion of the study (12 months) |
|
Target Sample Size
|
Total Sample Size="38" Sample Size from India="38"
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)
|
09/07/2025 |
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="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 single arm prospective study evaluates the effectiveness of individualized homeopathic medicine on executive function deficits in ADHD children by using the CHEXI scale. Secondary objective is assessing the effectiveness in symptom reduction in ADHD by using Snap IV scale. Children who present with behavioural changes from NHRIMH’s outpatient department and peripheral OPDs will be screened using a verbal screening questionnaire (Annexure-I) and diagnosed with ADHD based on DSM-5 criteria. With confirmation from a consultant psychiatrist, are eligible to enroll in the study; Parents/Legally authorized representatives will receive a Patient Information sheet (Annexure-II) and an informed consent form (Annexure-III) to obtain their informed consent prior to enrollment; Participants will give their verbal assent in the presence of a guardian, ensuring ethical participation; detailed case-taking will be documented in the case record format. Snap IV ADHD rating scale(annexure-IV) will be used to measure the baseline severity of ADHD symptoms. Additionally, CHEXI scale (annexure-V) will be used to do a baseline assessment of EF deficits in ADHD child. A comprehensive case-taking process will be conducted using a structured case record format, including detailed history and mental status examination. A totality of symptoms will be established, followed by repertorization using the Synthesis Repertory on RADAR OPUS software. The final remedy selection will be based on Homoeopathic Materia Medica. If there is no change at all, the case shall be retaken, and another appropriate medicine will be prescribed. If any adverse drug reactions occurs, will report to pharmacovigilance department. In cases of acute complaints, the best course of action will be given after the present acute totality has been evaluated. Patients will have follow-up every month for a period of 12 months. Three consecutive months without follow-up will result in the case being deemed a dropout. In order to reduce the number of dropouts, telephone consultations will be conducted, and participants will be requested to attend the follow-up. If drop out cases returning for treatment will be given regular treatment but will not include in the study further. Those who are willingly withdrawn from the study will also be given regular treatment but will not consider them for the purpose of study analysis. The Snap IV and CHEXI scale will be used to evaluate treatment’s effectiveness at baseline, 6th & 12th month of follow up period. Only after approval from the Clinical Trial Registry of India, the Kerala University of Health Sciences, and the Ethical Committee, enrolment will begin. |