| CTRI Number |
CTRI/2021/02/031031 [Registered on: 05/02/2021] Trial Registered Prospectively |
| Last Modified On: |
04/02/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
HOMOEOPATHY AND PSYCHOSES |
|
Scientific Title of Study
|
Effectiveness of Individualised Homoeopathic Medicines in the management of Psychoses |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Susu Pertin |
| Designation |
Post Graduate Scholar |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam |
| Address |
Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam
Kottayam
KERALA
686532
India |
| Phone |
6294346528 |
| Fax |
|
| Email |
omeoyi437@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Karunakara Moorthi |
| Designation |
Associate professor, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam |
| Address |
Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam
Kottayam
KERALA
686532
India |
| Phone |
8281502571 |
| Fax |
|
| Email |
drjaiguru@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Karunakara Moorthi |
| Designation |
Associate Professor, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health, Kottayam |
| Address |
Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam
Kottayam
KERALA
686532
India |
| Phone |
8281502571 |
| Fax |
|
| Email |
drjaiguru@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam |
|
|
Primary Sponsor
|
| Name |
Dr Susu Pertin |
| Address |
Department of Psychiatry,
National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam- 686532
Kerala |
| 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 |
| Susu Pertin |
National Homoeopathy Research Institute in Mental Health, Kottayam |
Department of Psychiatry, National Homoeopathy Research Institute in Mental Health, Sachivothamapuram P.O., Kottayam-686532
Kottayam
KERALA |
6294346528
omeoyi437@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F29||Unspecified psychosis not due to asubstance or known physiological condition, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Homoeopathic Medicines |
4 Doses of the most similar medicine with Potency starting
from 30C shall be administered.
More frequent doses will be given in acute cases i.e. hourly or daily whereas in chronic cases 1 dose per week will be administered and the cases will be followed up every month.
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 then another will be given. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of both genders in the age group of 18-60 years.
2. All cases of psychosis with more than 1month duration diagnosed by the psychiatrist as per ICD-10 criteria.
3. Those patients whose family or relatives are willing to give consent. |
|
| ExclusionCriteria |
| Details |
1. Patients with Organic psychosis.
2. Patients with suicidal and homicidal tendencies.
3. Substance-induced psychotic disorders.
4. Persons under treatment with Antipsychotics.
5. Pregnant and lactating women.
6. Mental retardation with psychotic symptoms.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the efficacy of Homoeopathic therapeutic intervention in the
management of Psychoses.
The primary outcome will be assessed every month with BPRS scale. The score on BPRS scale will determine the severity of psychotic symptoms.
|
1 year
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To find out the most commonly indicated remedies in Psychoses.
2. To assess the quality of life of patients before and after Homoeopathic
intervention.
The quality of life will be assessed with WHOQOL-BREF scale in every 3 months
(12 Weeks). |
1 year |
|
|
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 3 |
|
Date of First Enrollment (India)
|
09/02/2021 |
| 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
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
AIM To evaluate the efficacy of individualized Homoeopathic medicine in the management of general and specific symptom dimensions of Psychoses. PRIMARY OBJECTIVE: To evaluate the efficacy of Homoeopathic therapeutic intervention in the management of Psychoses. SECONDARY OBJECTIVES: 1. To find out the most commonly indicated remedies in Psychoses. 2. To assess the quality of life of patients before and after Homoeopathic intervention. NULL HYPOTHESIS (H0): Individualised Homoeopathic medicines are not effective in Psychoses. ALTERNATIVE HYPOTHESIS (H1): Individualised Homoeopathic medicines have a significant effect on Psychoses. METHODS OF DATA COLLECTION AND OUTCOME MEASUREMENT: Patients of both genders between the age of 18 and 60 shall be screened for symptoms of Psychosis with a screening questionnaire prepared using ICD-10 Diagnostic Criteria for Research at In-patient, Outpatient Departments and Peripheral camps of National Homoeopathy Research Institute in Mental Health, Kottayam. The screening format will be maintained in the OPDs.A detailed case taking will be done on the Case Recording Performa, based on Classical Homoeopathic Principles. After proper analysis and evaluation of symptoms of each case, repertorisation shall be done with Synthesis Repertory using RADAR software. The similimum will be selected on the basis of individualization of the patient as per the reportorial result, in consultation with Materia Medica. Potency starting from 30C shall be administered. Cases will be assessed at baseline with the Brief Psychiatric Rating Scale (BPRS) to determine the severity of the condition. The Quality of life of the subjects will also be assessed with 8 WHOQOL BREF at baseline. The severity of the assessment of psychotic symptoms will be done every month with the BPRS scale and Assessment of quality of life will be done every 3 months with WHOQOL BREF. The outcome of treatment will be assessed according to BPRS and WHOQOL BREF scale before and after administering individualized Homoeopathic medicine. |