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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 


 
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