| CTRI Number |
CTRI/2025/08/093245 [Registered on: 19/08/2025] Trial Registered Prospectively |
| Last Modified On: |
18/08/2025 |
| 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 homoeopathic medicines can help in adult suffering with schizophrenia. |
|
Scientific Title of Study
|
Effectiveness of individualized homoeopathic medicines in treating schizophrenia assessed using positive and negative syndrome scale- a clinical 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 Navina SK |
| Designation |
PG scholar |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
Room no-513, 4th floor, Department of psychiatry,
sarada krishna homoeopathic medical college
Kulasekharam
Kanniyakumari
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
8056088021 |
| Fax |
|
| Email |
navi.sk.sundar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subi PR |
| Designation |
Professor |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
Room no-510, 4th floor, department of psychiatry,
sarada krishna homoeopathic medical college
kulasekharam
kanniyakumari
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9486863644 |
| Fax |
|
| Email |
drsubinair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subi PR |
| Designation |
Professor |
| Affiliation |
Sarada krishna homoeopathic medical college |
| Address |
Room no-510, 4th floor, department of psychiatry,
sarada krishna homoeopathic medical college
kulasekharam
kanniyakumari
Kanniyakumari
TAMIL NADU
629161
India |
| Phone |
9486863644 |
| Fax |
|
| Email |
drsubinair@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institution - Sarada krishna homoeopathic medical college, kulasekharm, kanniyakumari, tamilnadu 629161 |
|
|
Primary Sponsor
|
| Name |
Post graduate research funded by sarada krishna homoeopathic medical college |
| Address |
Sarada krishna homoeopathic medical college
kulasekharam
kanniyakumari |
| 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 Navina SK |
Sarada krishna homoeopathic medical college |
Room no 513, 4th floor, department of psychiatry,
sarada krishna homoeopathic medical college
kulasekharam
kanniyakumari
Kanniyakumari
TAMIL NADU |
8056088021
navi.sk.sundar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sarada krishna homoeopathic medical college- Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualized Homeopathic Medicines |
After detailed case taking, individualized homoeopathic medicines are selected based symptom similarity either by repertial or non repertorial approach. Follow up is done every 2 weeks for 6 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
64.00 Year(s) |
| Gender |
Both |
| Details |
Patients already diagnosed with schizophrenia will be taken. |
|
| ExclusionCriteria |
| Details |
Pregnant women
History of substance abuse affecting cognitive functioning.
Patients when requiring a change in ongoing treatment during the time of homoeopathic treatment.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| follow up for every two weeks and assessment will be done for 3 months once by using positive and negative syndrome scale. |
follow up for every two weeks and assessment will be done for 3 months once by using positive and negative syndrome scale. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
30/08/2025 |
| 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="0"
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
|
Schizophrenia refers to a severe mental disorder
in which causes are unknown and also involves disturbances of thinking,
perception and by inappropriate or blunted affect.
It is the most severe mental disorders which the person has with a worldwide
prevalence of about 1% in population. The symptoms of schizophrenia are divided into three
groups such as positive, negative, and cognitive symptoms. Homoeopathy can be a useful treatment in
psychiatric cases to managing the patient holistically approach. Positive and negative syndrome scale is used
to assessed the severity of the schizophrenia, which contain positive, negative
and cognitive symptoms. Procedure - The patient is assessed
with positive and negative syndrome scale for knowing the
severity of schizophrenia before and after homoeopathic prescription. Outcome -follow up for every two
weeks and assessment will be done for 3 months once by using positive and
negative syndrome scale. |