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CTRI Number  CTRI/2025/06/089360 [Registered on: 23/06/2025] Trial Registered Prospectively
Last Modified On: 20/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Reduction of Internet Gaming Disorder in 10 to 18 years of age group with Homoeopathic medicine 
Scientific Title of Study   Effectiveness of Individualized Homoeopathic Medicine on Internet Gaming Disorder in Adolescents : A 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 APARNA M 
Designation  Pg scholar, Department of Psychiatry  
Affiliation  National Homoeopathy Research Institute In mental health  
Address  Room no 8 Post Graduate Scholar Department of Psychiatry National Homoeopathy Research Institute in Mental health

Kottayam
KERALA
686532
India 
Phone  9940377095  
Fax    
Email  aparnam6781@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bhuvaneswari R  
Designation  Professor ,Head of Department of Psychiatry  
Affiliation  National Homoeopathy Research Institute in Mental health 
Address  Room no 106 Professor and Head of department Department of Psychiatry National Homoeopathy Research Institute in Mental health
Room no 106 Professor and Head of department Department of Psychiatry National Homoeopathy Research Institute in Mental health
Kottayam
KERALA
686532
India 
Phone  8281475541  
Fax    
Email  dr.bhuvaneswarir@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Bhuvaneswari R  
Designation  Professor ,Head of Department of Psychiatry  
Affiliation  National Homoeopathy Research Institute in Mental health 
Address  Room no 108 Professor and Head of department Department of Psychiatry National Homoeopathy Research Institute in Mental health
Room no 108 Professor and Head of department Department of Psychiatry National Homoeopathy Research Institute in Mental health
Kottayam
KERALA
686532
India 
Phone  8281475541  
Fax    
Email  dr.bhuvaneswarir@gmail.com  
 
Source of Monetary or Material Support  
National Homoeopathy Research Institute in Mental health, Kottayam 
 
Primary Sponsor  
Name  Dr APARNA M 
Address  National Homoeopathy Research Institute in Mental Health, Sachivothamapuram p.o, Kurichy, Kottayam 686532 Kerala 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 APARNA  National Homoeopathy Research Institute in Mental Health,kottayam  OPD ,IPD , peripheral camps from Department of Psychiatry,National Homoeopathy Research Institute in Mental Health Sachivothamapuram p.o Kurichy Kottayam 686532
Kottayam
KERALA 		 9940377095

aparnam6781@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical commitee , National Homoeopathy 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: F01-F99||Mental, Behavioral and Neurodevelopmental disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Individualized 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 1 year. 
Comparator Agent  Not applicable  Not applicable  
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1.Cases satisfying Internet Gaming Disorder according to DSM 5 of participants age group between 10 years to 18 years of both genders

2.Score more than or equal to 21 in Internet Gaming Disorder scale
 
 
ExclusionCriteria 
Details  1.Patient with Autism Spectrum Disorder , Obsessive Compulsive Disorder ,Substance induced psychotic disorder

2.Cases with intellectual disability 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Assessment of changes in the severity of the symptoms on internet gaming disorder after administration of individualized homoeopathic medicines is done using Internet Gaming Disorder Scale item 9 - Short form (IGDS9-SF)  Every 3 months from baseline till conclusion of the study 
 
Secondary Outcome  
Outcome  TimePoints 
Know the group of Homoeopathic medicine effective in Internet Gaming Disorder   Every 3 months from baseline till conclusion of the study 
 
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)   02/07/2025 
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="8"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [aparnam6781@gmail.com].

  6. For how long will this data be available start date provided 26-06-2025 and end date provided 11-11-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
This Prospective study evaluates the effectiveness of individualized homoeopathic Medicine on Internet Gaming disorder in adolescents using the Internet Gaming Disorder Scale short form (IGDS9-SF). Secondary objectives include to find out group of homoeopathic medicines effective inInternet Gaming Disorder. Patients will be recruited from the Outpatient Department (OPD), Inpatient Department (IPD), and Peripheral Camps of the National Homoeopathic Research Institute in Mental Health (NHRIMH), Kottayam, following screening based on DSM V criteria. Enrolment requires psychiatric confirmation, and informed Assent will be obtained from legally authorised representative in English and Malayalam. Baseline assessment include IGDS9-SF for severity , with evaluations conducted monthly and trimonthly, respectively, . A detailed case history and individualized homoeopathic remedies will be prescribed based on repertorization via RADAR OPUS software and
Homoeopathic Materia Medica. Patients missing follow-ups for three consecutive months will be considered dropouts and will receive standard OPD care but will be excluded from further study evaluation. This study evaluates the effectiveness of Homoeopathic medicine in internet gaming disorder and to provide clinical evidence on homoeopathy it’s role on Internet gaming disorder in adolescents.
 
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