| CTRI Number |
CTRI/2024/03/064281 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
18/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Homeopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Homoeopathy In Treatment of Schizophrenia
|
|
Scientific Title of Study
|
Efficacy OF Homoeopathy In Cognitive Improvement Of Patients With
Schizophrenia Randomized Control 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 Jayashree |
| Designation |
PhD Scholar |
| Affiliation |
Sonajirao Kshirsagar Homoeopathic Medical College |
| Address |
Department of Psychiatry, ground floor, OPD number 3, Sonajirao
Kshirsagar Homoeopathic Medical College Vidhya Nagar College Road
Beed
Aurangabad
MAHARASHTRA
431122
India |
| Phone |
8547008842 |
| Fax |
|
| Email |
jayashree.janagam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR GAUSHAL MAHENDRAH |
| Designation |
Principal HOD |
| Affiliation |
Sonajirao Kshirsagar Homoeopathic Medical College |
| Address |
Department of Psychiatry, ground floor, OPD number 3, Sonajirao
Kshirsagar Homoeopathic Medical College Vidhya Nagar College Road
Beed
Aurangabad
MAHARASHTRA
431122
India |
| Phone |
8830555923 |
| Fax |
|
| Email |
info@skhmcb.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR JAYASHREE |
| Designation |
PhD Scholar |
| Affiliation |
Sonajirao Kshirsagar Homoeopathic Medical College |
| Address |
Department of Psychiatry, ground floor, OPD number 3, Sonajirao
Kshirsagar Homoeopathic Medical College Vidhya Nagar College Road
Beed
Aurangabad
MAHARASHTRA
431 122
India |
| Phone |
8547008842 |
| Fax |
|
| Email |
jayashree.janagam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sonajirao
Kshirsagar Homoeopathic, Medical College, Beed. |
|
|
Primary Sponsor
|
| Name |
Dr Jayashree |
| Address |
Sonajirao
Kshirsagar Homoeopathic Medical College |
| 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 Jayashree |
Sonajirao Kshirsagar Homoeopathic Medical College |
Department of Psychiatry, ground floor, OPD number 3, Sonajirao Kshirsagar Homoeopathic Medical College Vidhya Nagar College Road
Beed 431 122
Aurangabad
MAHARASHTRA |
8547008842
jayashree.janagam@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sonajirao Kshirsagar Homoeopathic Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F200||Paranoid schizophrenia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I: Indicated
Homoeopathic
medicine |
Indicated Homoeopathic medication, with or
without conventional medication.
Dosage: 30 potencies once a week, gradually will be increasing the potencies depending upon the need of the patient.
Mode of administration: oral route.
Follow up period: 12 months |
| Comparator Agent |
Group II Conventional Medicine
with Placebo |
Placebo with conventional medication.
Dosage: Placebo will be given daily twice.
Mode of administration: oral route.
Follow up period: 12 months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients between 20 years old and 65 years of age who have fulfilled ICD 10 diagnostic criteria of
schizophrenia. |
|
| ExclusionCriteria |
| Details |
1.Patients of schizophrenia with pregnancy
2.Substance induced psychotic disorder.
3.Patients with organic psychosis.
4.Cases with life-threatening Systemic illness. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the improvement in executive
functioning of patients with schizophrenia
after
Homoeopathic interventions. |
To assess the improvement in executive
functioning of patients with schizophrenia
after
Homoeopathic interventions.
Outcome assessment will be done at baseline and every 3months interval. PANSS and SCoRs scales will be used for the assessment. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out changes in WHO quality
of life in Schizophrenia patients,
after individualized
Homoeopathic medicine. |
Patient’s quality of life is measured by
World Health Organization quality of life (WHO
QOL) will be assessed at the baseline & at the interval of every 3months.
All cases followed for a period of one year.
|
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
30/03/2024 |
| 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="0"
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
|
TITLE EFFICACY OF HOMOEOPATHY IN COGNITIVE IMPROVEMENT OF PATIENTS WITH SCHIZOPHRENIA: RANDOMISED CONTROL STUDY
MATERIALS AND METHODS OF STUDY
Research Question Is there any significant improvement in cognitive functioning of schizophrenia, after Prescribing Homeopathic medicine?
Aim: To find out the cognitive improvement in patients with schizophrenia after Homeopathic management.
Primary Objective: • To assess the improvement in executive functioning of patients with schizophrenia after Homoeopathic interventions.
Secondary Objectives: • To find out changes in WHO quality of life in Schizophrenia patients, after individualized Homoeopathic medicine.
Null Hypothesis (H0) Homoeopathic remedies are not significant in improving cognitive functions of schizophrenia.
Alternative Hypothesis (H1) Homoeopathic remedies are significant in improving cognitive functions of Schizophrenia.
Study type: Randomized control study Setting: OPD, IPD and peripheral OPDs of the Institute.
Sampling: Randomized sampling
Sample size: The sample size will be 68, calculated by using the G.Power 3.1 version
Inclusion Criteria • Patients between 20 and 65 years of age who have fulfilled ICD 10 diagnostic criteria of schizophrenia.
Exclusion Criteria • Patients of schizophrenia with pregnancy • Substance induced psychotic disorder. • Patients with organic psychosis. • Cases with life-threatening Systemic illness |