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
|
|
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
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Clinical Study Report
- 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.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [leninsurendran161@gmail.com].
- 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.
- 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. |