| CTRI Number |
CTRI/2025/06/089585 [Registered on: 25/06/2025] Trial Registered Prospectively |
| Last Modified On: |
25/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Reduction Of Abnormal Involuntary Movemrnts of antipsychotics using Homoeopathic Medicines |
|
Scientific Title of Study
|
A PROSPECTIVE OPEN LABEL SINGLE ARM STUDY ON THE
EFFECTIVENESS OF HOMOEOPATHIC MEDICINES IN REDUCING THE
ABNORMAL INVOLUNTARY MOVEMENTS OF ANTIPSYCHOTIC
INDUCED TARDIVE DYSKINESIA |
| 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 DEEPU C S |
| Designation |
POST GRADUATE SCHOLAR, DEPARTMENT OF PSYCHIATRY, |
| Affiliation |
KERALA UNIVERSITY OF HEALTH SCIENCES(KUHS) |
| Address |
Post Graduate Scholer
Department Of Psychiatry
Room No 8
National Homoeopathy Research Institute in Mental Health Kurichy,Sachivothamapuram P O, Kottayam, Kerala, 686532
Kottayam
KERALA
686532
India |
| Phone |
8921903116 |
| Fax |
|
| Email |
deepzzzz118@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SREEJA K R |
| Designation |
ASSISTANT PROFFESOR |
| Affiliation |
KERALA UNIVERSITY OF HEALTH SCIENCES(KUHS) |
| Address |
ASSISTANT PROFFESOR
Department Of Psychiatry
Room No 6
National Homoeopathy Research Institute in Mental Health Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9495105766 |
| Fax |
|
| Email |
jaisankarsreeja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SREEJA K R |
| Designation |
ASSISTANT PROFFESOR |
| Affiliation |
KERALA UNIVERSITY OF HEALTH SCIENCES(KUHS) |
| Address |
ASSISTANT PROFFESOR
Department Of Psychiatry
Room No 6
National Homoeopathy Research Institute in Mental Health Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9495105766 |
| Fax |
|
| Email |
jaisankarsreeja@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health |
|
|
Primary Sponsor
|
| Name |
Dr DEEPU C S |
| Address |
National Homoeopathy Research Institute in Mental Health Kurichy,Sachivothamapuram P O, Kottayam, Kerala, 686532 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DEEPU C S |
National Homoeopathy Research Institute in Mental Health |
National Homoeopathy Research Institute in Mental Health Kurichy,Sachivothamapuram P O, Kottayam, Kerala, 686532
Kottayam
KERALA |
8921903116
deepzzzz118@gmail.com |
| DEEPU C S |
OPD, IPD & Peripheral Camps of National Homoeopathy Research Institute in mental Health |
National Homoeopathy Research Institute in Mental Health Kurichy,Sachivothamapuram P O, Kottayam, Kerala, 686532
Kottayam
KERALA |
8921903116
deepzzzz118@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: F99||Mental disorder, not otherwise specified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic medicines |
After enrollment the case will be repertorised. Appropriate
potentized 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 |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participants of any gender in age group 18-80 yrs
Participants having score greater than or equal 2 of AIMS
Psychiatric patients who are under antipsychotic treatment for at least 3 months if below 60 |
|
| ExclusionCriteria |
| Details |
Those with stereotyped movement disorders
Pregnant and lactating women
Those with antipsychotic withdrawal emergent dyskinesia
Those who are in alcohol withdrawal state |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of reduction in the severity of TD after Homoeopathic medicines by using AIMS |
AIM Scale at baseline and at the end of study (after 6 months ) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the general improvement of the patient |
QOL Scale at baseline & at the end of study (after 6 months ) |
|
|
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)
|
06/07/2025 |
| 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [deepzzzz118@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 prospective open label single arm study evaluates the effectiveness of Homoeopathic Medicines
in reducing the abnormal involuntary movements of anti psychotic induced Tardive Dyskinesia using
Abnormal Involuntary Movement Scale(AIMS) Secondary objective include assessing improvements
in quality of life of patient through WHO-QOL BREF scale .Patients will be recruited from the Out patient
Department(OPD),In patient Department(IPD),and Peripheral Centres of the National Homoeopathic
Research Institute in Mental Health (NHRIMH), Kottayam, following screening based on Verbal
Screening Questioner Enrolment requires psychiatric confirmation ,and informed consent/Assent will
be obtained from legally authorised representative in English and Malayalam .Baseline assessment
include AIMS for severity, with evaluations conducted monthly and tri-monthly, respectively ,while
quality of lifewillbemonitoredusingtheWHO-QOLBREFscale.Adetailedcasehistoryandoneon
the case recording format and indicated Homoeopathic remedies will be prescribed based on repertorization via RADAR OPUS software and in comparison with Homoeopathic Materia Medica.
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
effectiveness of Homoeopathy’s role as an adjuvant therapy in Tardive Dyskinesia, assessing its
ability to improve symptoms and enhance the quality of life |