| CTRI Number |
CTRI/2024/09/073577 [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 |
Single Arm Study |
|
Public Title of Study
|
Usefulness of Homoeopathic medicine in the management of Schizophrenia |
|
Scientific Title of Study
|
Effectiveness of individualised Homoeopathic medicine in the management of affect in Schizophrenia- a single arm prospective 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 Akshay V |
| Designation |
Post graduate scholar, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram (P.O) Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9633630983 |
| Fax |
|
| Email |
akshayvallikkad.av@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayashree Janagam |
| Designation |
Assistant professor, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram (P.O) Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9177709429 |
| Fax |
|
| Email |
drjayajanagam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jayashree Janagam |
| Designation |
Assistant professor, Department of Psychiatry |
| Affiliation |
National Homoeopathy Research Institute in Mental Health |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram (P.O) Kurichy
Kottayam
KERALA
686532
India |
| Phone |
9177709429 |
| Fax |
|
| Email |
drjayajanagam@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Homoeopathy Research Institute In Mental Health Kottayam |
|
|
Primary Sponsor
|
| Name |
Dr Akshay V |
| Address |
National Homoeopathy Research Institute in Mental Health,
Sachivothamapuram (P.O), Kurichy Kottayam |
| 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 Akshay V |
National Homoeopathy Research Institute in Mental Health |
OPD (Room No.9),IPD-Ground floor, Camps and
Peripheral Units,
Department of
Psychiatry
Kottayam
KERALA |
9633630983
akshayvallikkad.av@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: F20||Schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Individualised Homoeopathic medicine |
Homoeopathic medicine will be given in minimum dose.Potency and frequency of repetition will be according to the severity of the symptoms of the patient.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who fulfill the diagnostic criteria for schizophrenia in ICD 10
2. Patients of ages from 19 to 65
3. Patients of all genders. |
|
| ExclusionCriteria |
| Details |
1. Patients with substance-induced psychotic illness.
2. Other Mood disorders
3. Patients with life-threatening systemic illness.
4. Patients who are pregnant and lactating mothers. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of changes in the affect of schizophrenia
after administering individualized Homoeopathic medicine is planned to be done 3rd 6th 9th and
12th months by using the PANAS Scale |
6 months for enrollment. One year for follow-up and intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Improvement in the severity of illness of schizophrenia
after administering individualized Homoeopathic medicine is planned to be done 3rd 6th 9th and
12th months by using the PANSS scale |
6 months for enrollment. One year for follow-up and intervention |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
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 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
|
This study is an open label, single arm, clinical interventional study to determine the effectiveness of Individualized Homoeopathic Medicines in the management of affect in schizophrenia that will be conducted in OPD, IPD and Peripheral units of Department of Psychiatry at National Homoeopathy Research Institute in Mental Health, Kottayam. The primary outcome measures , improvement in positive affect and reduction in negative affect of schizophrenia; assessed using the Positive and Negative Affect Schedule (PANAS) Score at baseline,3rd month,6th month, and 12th month. The secondary outcome will be, improvement in the intensity of symptoms in patients with schizophrenia, after administration of individualized homoeopathic medicine using the PANSS Scale; assessed at baseline,3rd month,6th month, and 12th month by using the Positive and Negative Syndrome Scale (PANSS). As the study with the aforementioned domains is one of its kind, it aims to make the efforts offer possibilities for future research in the effectiveness of Individualized Homoeopathic Medicines in management of affect in schizophrenia |