| 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
|
|
|
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
|
|
|
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. |