| CTRI Number |
CTRI/2024/09/073575 [Registered on: 09/09/2024] Trial Registered Prospectively |
| Last Modified On: |
06/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Homoeopathic treatment for conduct disorder in children |
|
Scientific Title of Study
|
Effectiveness Of Individualised Homoeopathic Medicines In The Management Of Conduct Disorder With Supportive Counselling-A Double-Blind Randomised Placebo-Controlled Trial |
| 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 Ramya V S |
| Designation |
Post Graduate scholar |
| Affiliation |
National Homoeopathy Institute in Mental Health |
| Address |
Room no 48
Department of Psychiatry
National Homoeopathy Institute in Mental Health
Sachivothamapuram (PO)
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
6238366976 |
| Fax |
|
| Email |
ramyasunny95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Bhuvaneswari |
| Designation |
Professor And Head Of Department Department Of Psychiatry Research Officer (H) Scientist III |
| Affiliation |
National Homoeopathy Institute in Mental Health |
| Address |
Room no 48
Department of Psychiatry
National Homoeopathy Institute in Mental Health
Sachivothamapuram (PO)
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Bhuvaneswari |
| Designation |
Professor And Head Of Department Department Of Psychiatry Research Officer (H) Scientist III |
| Affiliation |
National Homoeopathy Institute in Mental Health |
| Address |
Room no 48
Department of Psychiatry
National Homoeopathy Institute in Mental Health
Sachivothamapuram (PO)
Kurichy
Kottayam
KERALA
686532
India |
| Phone |
8281475541 |
| Fax |
|
| Email |
dr.r.bhuvaneswari2021@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoepathy Research Institute In Mental Health Sachivothamapuram (P O) Kurichy Kottayam Kerala 686532 India |
|
|
Primary Sponsor
|
| Name |
Dr Ramya V S |
| Address |
Department Of Psychiatry National Homoepathy 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 Ramya V S |
National Homoeopathy Research Institute In Mental Health |
Room no 48, Outpatient department (OPD), Inpatient Department (IPD), and Peripheral camps under the Department of Psychiatry, National Homoepathy Research Institute In Mental Health Sachivothamapuram (P O) Kurichy Kottayam Kerala 686532 India
Kottayam
KERALA |
6238366976
ramyasunny95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,National Homoepathy Research Institute In Mental Health |
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 |
Homoeopathic medicines with supportive counselling |
The medicine potency ranging from 6c to 10M will be given 4-6 pills of number 30 size, dose and frequency repetition will be according to severity of symptom of patient with supportive counselling. |
| Comparator Agent |
placebo with
supportive counselling. |
placebo 4-6 pills of number 30 in size will be administered with supportive counselling |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group between 6-17 years of both genders.
2. Cases satisfying Conduct Disorder diagnostic criteria of DSM 5
3. Who is willing to provide informed written consent/assent form |
|
| ExclusionCriteria |
| Details |
1. Patients with antisocial personality disorder, ADHD, Intellectual Disability
2. Patients with organic psychosis.
3. Patients with pervasive developmental disorder
4. Known cases of uncontrolled Systemic illness
5. Substance-induced psychotic disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the Effectiveness of Individualized Homoeopathic Medicines In Reducing The
Disruptive Behavior In Conduct Disorder Using the Conduct Disorder Rating Scale (CDRS)
Parent Version Comparing Outcomes with Placebo.
|
every month from baseline till the conclusion of study(6th month) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find out the changes in the severity of conduct disorder using the Clinician Rated Severity Of Conduct Disorder.
2. To evaluate the overall improvement of the conduct disorder by using the Clinical Global Improvement Scale.
|
every 3 months |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 3 |
|
Date of First Enrollment (India)
|
17/09/2024 |
| 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 - NO
|
|
Brief Summary
|
This study
is a randomized, double blind, parallel group trial comparing Effectiveness Of
Individualised Homoeopathic Medicines In The Management Of Conduct Disorder
With Supportive Counselling-A Double-Blind Randomised Placebo-Controlled Trial that
will be conducted in Outpatient department (OPD), Inpatient Department (IPD),
and Peripheral camps under the Department of Psychiatry, NHRIMH, Kottayam. The
primary outcome measures will be To compare the Effectiveness of Individualized
Homoeopathic Medicines In Reducing The Disruptive Behavior In Conduct Disorder
Using the Conduct Disorder Rating Scale (CDRS) Parent Version Comparing
Outcomes with a Placebo every month. The secondary outcomes will be To find out
the changes in the severity of conduct disorder using the Clinician Rated
Severity Of Conduct Disorder and To evaluate the overall improvement of the
conduct disorder by using the Clinical Global Improvement Scale every three
months |