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CTRI Number  CTRI/2025/06/089412 [Registered on: 24/06/2025] Trial Registered Prospectively
Last Modified On: 19/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Homeopathy 
Study Design  Single Arm Study 
Public Title of Study   Homoeopathic management of conduct disorder 
Scientific Title of Study   Effectiveness of individualized homoeopathic medicine in Reducing the callous unemotional traits in conduct Disorder 
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 LENIN K S 
Designation  POST GRADUATE TRAINEE, DEPT OF PSYCHIATRY 
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  Room no 47, Department of psychiatry National Homoeopathy Research Institute in Mental Health, Sachivothamapuram p o, kurichy, kottayam

Kottayam
KERALA
686532
India 
Phone  9600481609  
Fax    
Email  leninsurendran161@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr M GNNANAPRAKASHAM 
Designation  ASSOCIATE PROFESSOR  
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  Room no 47, Department of psychiatry National Homoeopathy Research Institute in Mental Health, Sachivothamapuram p o, kurichy, kottayam

Kottayam
KERALA
686532
India 
Phone  9444701176  
Fax    
Email  drgprakashpsy@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr M GNNANAPRAKASHAM 
Designation  ASSOCIATE PROFESSOR  
Affiliation  National Homoeopathy Research Institute in Mental Health 
Address  Room no 47, Department of psychiatry National Homoeopathy Research Institute in Mental Health, Sachivothamapuram p o, kurichy, kottayam

Kottayam
KERALA
686532
India 
Phone  9444701176  
Fax    
Email  drgprakashpsy@gmail.com  
 
Source of Monetary or Material Support  
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram p o, kurichy, kottayam kerala 686532 India 
 
Primary Sponsor  
Name  Dr Lenin K S 
Address  National Homoeopathy 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 LENIN K S  National Homoeopathy Research Institute in Mental Health  National Homoeopathic Research Institute in Mental Health,Sachivothamapuram p o, kurichy, kottayam, kerala-686532
Kottayam
KERALA 
9600481609

leninsurendran161@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee -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: F918||Other conduct 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 6 months. 
Comparator Agent  Not applicable  Not applicable 
 
Inclusion Criteria  
Age From  6.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  Cases satisfying Conduct Disorder diagnostic criteria of DSM-5.
Age group between 6-18 years of both genders.  
 
ExclusionCriteria 
Details  1. Children and adolescents suffering from other major known Psychiatric
conditions, such as early-onset schizophrenia, autism spectrum disorders, anxiety
disorders, and other known serious systemic diseases, including genetic
conditions, will be excluded from this study.
2. Pregnant and lactating women.  
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Reduction in ICU scale denotes reduction in callous-unemotional
traits, which indicates effectiveness of Individualized Homoeopathic medicine.  
Baseline, 3months once 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in CDRS indicates improvement of CD   monthly once 
Improvement in the CGI Scale at various time intervals, as mentioned
before,indicates overall improvement of conduct disorder. 
6 months once 
 
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)   30/06/2025 
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 - 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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [leninsurendran161@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 quasi-experimental clinical study evaluates the effectiveness of individualized homoeopathic medicine in reducing the callous unemotional traits in conduct disorder using the inventory callous unemotional Scale (ICU). Secondary objectives include assessing overall improvement in conduct disorder through the Conduct disorder rating scale (CDRS) scale and clinical global improvement (CGI), determining whether homoeopathy helps reducing the callous unemotional traits in conduct disorder. Patients will be recruited from the Outpatient Department (OPD), Inpatient Department (IPD), and Peripheral Centre of the National Homoeopathic Research Institute in Mental Health (NHRIMH), Kottayam, following screening based on DSM 5 criteria. Enrolment requires psychiatric confirmation, and informed consent will be obtained in English and Malayalam. Baseline assessments include ICU for Callous unemotional traits and CDRS for conduct disorder, with evaluations conducted monthly and trio-monthly, respectively, . A detailed case history and mental status examination will be recorded, and individualized homoeopathic remedies will be prescribed based on repertorization via RADAR OPUS software and Homoeopathic Materia Medica. Acute exacerbations will be managed accordingly.  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. The study aims to provide clinical evidence on homoeopathy’s role as an reducing the callous unemotional traits in conduct disorder assessing its ability to improve symptoms, enhance quality of life and avoids antisocial personality in future of the affected individuals.

 
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