Effectiveness of individualised homoeopathic medicine on executive function deficits in attention deficit/hyperactivity disorder children – a single arm, prospective study.

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 Those who are willingly withdrawn from the study will also be given regular treatment but will not consider them for the purpose of study analysis.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.