| CTRI Number |
CTRI/2024/06/068405 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
28/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Examining the Efficacy of Holistic Approaches in Managing Schizophrenia: A Comparative Analysis |
|
Scientific Title of Study
|
Assessing and Comparing the role Of Holistic approaches activity in the management of Schizophrenia patient |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sakshi Nibude |
| Designation |
Post Graduate Student |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department Clinical Research Sawangi Wardha
Wardha MAHARASHTRA 442001 India |
| Phone |
9021459178 |
| Fax |
|
| Email |
sakshinibude2002@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Pradip Patil |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Psychiatry AVBRH campus Sawangi
Wardha MAHARASHTRA 442001 India |
| Phone |
8999248979 |
| Fax |
|
| Email |
dr.p.s.patil2012@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Pradip Patil |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Dept of Psychiatry AVBRH campus Sawangi
MAHARASHTRA 442001 India |
| Phone |
8999248979 |
| Fax |
|
| Email |
dr.p.s.patil2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institude of Higher Education and Research |
| Address |
Sawangi Wardha |
| 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 Sakshi Manohar Nibude |
Aacharya Vinoba Bhave Rural Hospital Sawangi Wardha |
Department of Psychiatric Aacharya Vinoba Bhave Rular Hospital Sawangi Meghe Wardha MAHARASHTRA |
9021459178
sakshinibude2002@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institude of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F439||Reaction to severe stress, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Aged 18 to 65 patients
Depression
Anxiety
Sadness |
|
| ExclusionCriteria |
| Details |
Above 65 Age.
Children.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| better quality of life, reduced relapse rates |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| better quality of life, reduced relapse rates |
1 year |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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
|
N/A |
|
Date of First Enrollment (India)
|
23/07/2024 |
| 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
|
The exact cause of schizophrenia, a severe neuropsychiatric illness, is still mostly unknown. Schizophrenia is a debilitating psychotic disorder. While many different factors have been linked to the onset of schizophrenia, the primary cause of the condition is still unknown. Psychosocial stress is one of the main environmental factors linked to schizophrenia, and it has been reported that these factors play roles in the pathogenesis of the disorder. Numerous researches have hypothesized that stressful life experiences and the continual social stress that comes with living in a city may cause schizophrenia to develop. Debilitating symptoms of both positive and negative symptoms affecting emotions and cognition can be seen in schizophrenia. Positive symptoms of schizophrenia include delusions, hallucinations, and disorderly speech and behavior. Negative symptoms include affective flattening and lack of motivation. Specific regulation from molecular signaling pathways is necessary for the development of the neural systems underpinning the social, cognitive, and emotional domains. Engaging in stimulating activities such as painting, drawing, dancing, and other art-related pursuits not only stimulates brain activity but also plays a role in promoting mental wellness. Additionally, participating in sports and physical activities contributes to increased blood flow to the brain, potentially reducing the risk of developing long-term mental health issues like schizophrenia. Better symptom management, an improvement in quality of life, an improvement in relapse rates, better treatment adherence, and long-term benefits are anticipated from the use of holistic approaches in the management of patients with schizophrenia. |