| CTRI Number |
CTRI/2025/08/093529 [Registered on: 25/08/2025] Trial Registered Prospectively |
| Last Modified On: |
22/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Study on how Homoeopathy can help children with Serious Behaviour Problems |
|
Scientific Title of Study
|
Effect of Individualised Homoeopathic medicine with Behavioural therapy in managing Conduct Disorder among Children: A Prospective Observational 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 Chinny J |
| Designation |
Post Graduate Student |
| Affiliation |
Sarada Krishna Homoeopathic Medical college |
| Address |
409, third floor, college building, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari Tamil nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9566536993 |
| Fax |
|
| Email |
chinnydevakarunai@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mahadevi A L |
| Designation |
Assistant professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical college |
| Address |
409, third floor, college building, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari Tamil nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9487417922 |
| Fax |
|
| Email |
mahaiyapp338@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mahadevi A L |
| Designation |
Assistant professor |
| Affiliation |
Sarada Krishna Homoeopathic Medical college |
| Address |
409, third floor, college building, Sarada Krishna Homoeopathic Medical College, Kulasekharam, Kanniyakumari Tamil nadu
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9487417922 |
| Fax |
|
| Email |
mahaiyapp338@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institution - Sarada krishna homoeopathic Medical College, Kulasekharam, Tamilnadu - 629161 |
|
|
Primary Sponsor
|
| Name |
Sarada Krishna Homoeopathic Medical College |
| Address |
Sarada krishna homoeopathic Medical College, Kulasekharam, Tamilnadu, India - 629161 |
| Type of Sponsor |
Private 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 Chinny J |
Sarada Krishna Homoeopathic Medical college |
108, Department of Paediatrics, Sarada Krishna Homoeopathic Medical College and Hospital, Kulasekharam, Kanniyakumari, Tamil Nadu 629161
Kanniyakumari
TAMIL NADU |
9566536993
chinnydevakarunai@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee Sarada Krishna Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F91||Conduct disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic Medicine |
Medicines will be selected through proper case taking and repertorization and administered orally according to Homoeopathic principles. potency - starts with 30c. Dose -daily * HS for 6 months. Repetition of medicine and change in potency will be decided based on the improvement of the patient through each follow up |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Patients within the Pediatric age group 3 -18 years of age.
Patients of both sexes.
Patients diagnosed with conduct disorder according to DSM 5 criteria.
Comorbid conditions ASD, ADHD and ODD etc., are also included.
|
|
| ExclusionCriteria |
| Details |
Patients with symptoms that are solely a reaction to a negative environment, episodes of mood or psychotic disorders.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To identify the effectiveness of integrated approach of individualized homeopathic medicine with behavioral therapy in conduct disorders. |
1 year 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Understanding the different causes of conduct disorder.
Assess the progress of improvement using conduct disorder rating scale (CDRS) in conduct disorder and NICHQ Vanderbilt scale in case if it is associated with other mental disorders such as ADHD, ODD etc., |
1 year 6 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/09/2025 |
| 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 Yet Recruiting |
| 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
|
The study aims to evaluate the effectiveness of homoeopathy with behavioural therapy in children with conduct disorder. A total of 28 cases
presenting with conduct disorder symptoms diagnosed according to the DSM 5 criteria and which satisfy the inclusion
criteria will be obtained from OPD, IPD, rural health centers and
school health programs conducted by Sarada Krishna Homoeopathic Medical College. Medicines
will be prescribed according to the individualization and totality of symptoms and repertorization. Potency and
repetition of medicines will be done according to the principles laid down in
the organon of medicine. Behavioural
therapy is given as per the severity of symptoms. Follow- up
will be taken every month, pre and post intervention assessment will be done using CDRS and NICHQ Vanderbilt scale at an interval of every 3 months. The primary outcome identifies the effectiveness of integrated approach of individualized
homeopathic medicine with behavioral therapy in such cases and secondary outcomes include understanding different causes of conduct disorder and the utility of conduct disorder rating scale (CDRS) in conduct disorder NICHQ Vanderbilt
scale in case if it is associated with other mental disorders such as ADHD, ODD
etc., |