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CTRI Number  CTRI/2025/12/099969 [Registered on: 31/12/2025] Trial Registered Prospectively
Last Modified On: 27/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Homeopathy
Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Role of Homoeopathic treatment in children with Conduct disorder  
Scientific Title of Study   ROLE OF INDIVIDUALISED HOMOEOPATHIC MEDICINES IN THE MANAGEMENT OF CONDUCT DISORDER IN PAEDIATRIC AGE GROUP: A PROSPECTIVE SINGLE ARM PRE-POST ASSESSMENT INTERVENTIONAL 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 Jyothsna P V 
Designation  PGT 
Affiliation  National Institute of Homoeopathy 
Address  OPD Room No 32 Department of Paediatrics National Institute of Homoeopathy Block GE Sector III Salt lake Kolkata

Kolkata
WEST BENGAL
700106
India 
Phone  8281811922  
Fax    
Email  jyothsnapv1995@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Kalasapakam Vijay Ananth 
Designation  HOD Department of Anatomy 
Affiliation  National Institute of Homoeopathy 
Address  OPD Room No 32
Department of Paediatrics
Kolkata
WEST BENGAL
700106
India 
Phone  8584888058  
Fax    
Email  vjananth74@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kalasapakam Vijay Ananth  
Designation  HOD Department of Anatomy 
Affiliation  National Institute of Homoeopathy 
Address  OPD Room No 32
Department of Paediatrics
Kolkata
WEST BENGAL
700106
India 
Phone  8584888058  
Fax    
Email  vjananth74@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Homoeopathy, Block GE, Sector III, Salt lake, Kolkata, West Bengal,700106, India  
 
Primary Sponsor  
Name  National institute of Homoeopathy 
Address  National Institute of Homeoepathy GE Block Sector 3 Saltlake Kolakta 
Type of Sponsor  Government medical college 
 
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 Jyothsna P V  National Institute of Homeoepathy GE Block Sector 3 Saltlake Kolakta  OPD No 32 Paediatrics OPD National Institute of Homeoepathy GE Block Sector 3 Saltlake Kolakta
Kolkata
WEST BENGAL 
08281811922

jyothsnapv1995@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National institute of Homoeopathy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F919||Conduct disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Medicine  Individualised Homoeopathic medicine. Oral administration of single dose of individualised Homoeopathic medicine with repeated at fixed interval of time depending as required by the cases for a duration 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
Participants or parents who are willing to give written informed consent to participate in the study and to give verbal or written assent
Participants pr parents / guardians who can read or write or understand either English or Hindi or Bengali languages 
 
ExclusionCriteria 
Details  Children and adolescents suffering from violent and complicated conditions
Diagnosed cases of other major Psychiatric conditions such as Oppositional Defiant Disorder, ADHD, ASD, Mental retardation, Mood disorders, Intermittent explosive disorders, substance use disorders
Cases with special learning disorder and adjust disorders
Other serious systemic diseases including genetic conditions
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Change in the mean score of Conduct Disorder and Oppositional Defiant Disorder Scale in managing the Conduct disorder in pediatric age group after 6 months of individualised Homoeopathic medicine  Baseline and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. To evaluate the changes in the MONARCH scale after of individualized Homoeopathic medicine.
2. To evaluate any Adverse Drug Reaction (ADR) or Adverse Drug Events (ADE) using Adverse Drug Reaction probability score 
Baseline and 6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   07/01/2026 
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="0"
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  

  Conduct disorder is a repetitive and persistent pattern of behavior in which the basic rights of others or major age-appropriate social norms or rules are violated. The symptoms of CD are categorized into four characteristics: 1. aggression to people and animals, 2. destruction of property, 3. deceitfulness or theft, and 4. serious violations of rules. In the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders DSM 5 CD is labeled as Disruptive, Impulse Control and Conduct Disorders. For diagnosis of CD, the individual should present with three persistent behaviors in Conduct Disorder Rating Scales over a period of 12 months with at least one of them present in the last 6 months. 

   1. Children presenting with behavioral changes from Pediatric Outpatient Department and will be screened with questions developed based on DSM5 criteria. 

   2. After screening, using the Conduct Disorder Rating Scale the cases with Conduct Disorder, fulfilling inclusion criteria will be enrolled for the study, after approval from Psychiatrist. 

   3. The Informed consent form will be obtained from parents or caregiver based on the availability and priority. 

   4. Detailed case taking will be done in the case record format prepared for the study. Baseline Investigation will be done as per the need of the case. 

  5. Cases will be assessed at baseline with Conduct Disorder rating Scale and monthly assessment will be done using the Conduct Disorder and Oppositional Defiant Disorder scale Parent Report Version. 

  6. Homoeopathic assessment will be done on every month using Modified Naranjo Criteria. 

  7. After the assessment of the case, through analysis and evaluation of the complete case, the individual totality is obtained and repertorization will be done with Synthesis Repertory. Final selection of remedy will be done in consulting with Homoeopathic Materia Medica. 

   8. After evaluation of each case, selected medicine will be prescribed in proper potency. On status quo, next higher potency will be prescribed. In case of no improvement or any new symptoms observed on consequent 3 months, the case will be retaken and change of remedy is proposed. 

   9. If any acute complaints, acute totality will be taken, and the appropriate remedy will be administered. All the Homoeopathic management part will be conducted following strict Homoeopathic Principles. Each case will be reviewed every 4 weeks interval.

   10. Outcome of treatment will be assessed according to symptomatic improvement of the subjects and changes in conduct disorder rating scale parent version and clinician rated severity of conduct disorder, clinical global improvement scale on various time intervals as mentioned before. 

    11. The patients enrolled in the study will be followed closely by providing follow up charts and regular reminders will be given through phone or any other communications.

 
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