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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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