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CTRI Number  CTRI/2024/11/077214 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 13/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Impact of Screen Time on Mental Health through Ayurvedic Body Types 
Scientific Title of Study   Association Between Screen Time And Mental Wellness Among Different Doshaja Prakriti - A Cross Sectional Observational 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  Mularam Suthar 
Designation  PhD Scholar 
Affiliation  G J Patel Institute of Ayurvedic Studies and Research 
Address  Department of Kriya Sharir G J Patel Institute of Ayurvedic Studies and Research New Vallabh Vidyanagar Anand Gujarat

Anand
GUJARAT
388120
India 
Phone  9783585696  
Fax    
Email  drmularam@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sarita S Bhutada 
Designation  Professor and Head of Department 
Affiliation  G J Patel Institute of Ayurvedic Studies and Research  
Address  Department of Kriya Sharir G J Patel Institute of Ayurvedic Studies and Research New Vallabh Vidyanagar Anand Gujarat

Anand
GUJARAT
388120
India 
Phone  9422348655  
Fax    
Email  sarita.bhutada@cvmu.edu.in  
 
Details of Contact Person
Public Query  
Name  Mularam Suthar 
Designation  PhD Scholar 
Affiliation  G J Patel Institute of Ayurvedic Studies and Research 
Address  Department of Kriya Sharir G J Patel Institute of Ayurvedic Studies and Research New Vallabh Vidyanagar Anand Gujarat

Anand
GUJARAT
388120
India 
Phone  9783585696  
Fax    
Email  drmularam@gmail.com  
 
Source of Monetary or Material Support  
Mularam Suthar Self Funded Project PhD Scholar G J Patel Institute of Ayurvedic Studies and Research New Vallabh Vidyanagar Anand Gujarat India 388120 
 
Primary Sponsor  
Name  Mularam Suthar 
Address  Department of Kriya Sharir G J Patel Institute of Ayurvedic Studies and Research New Vallabh Vidyanagar Anand Gujarat 
Type of Sponsor  Other [Self] 
 
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 
Mularam Suthar  G J Patel Institute of Ayurvedic Studies and Research  Room no. 322 Department of Kriya Sharir G J Patel Institute of Ayurvedic Studies and Research New Vallabh Vidyanagar Anand
Anand
GUJARAT 		 9783585696

drmularam@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional (Human) Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals of aged between 18-40 years of either gender will be enrolled in this study. 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Healthy individuals of aged between 18-40 years of either gender will be enrolled in this study. 
 
ExclusionCriteria 
Details  Severe mental health disorders like Neurodevelopmental disorders 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study aims to create tailored recommendations for managing screen time based on Deha Prakriti to enhance mental health.

 		 2 years 
 
Secondary Outcome  
Outcome  TimePoints 
The guidelines will be customized according to the specific effects of screen time on different Deha Prakriti, including strategies for screen time limits and breaks.   2 years 
 
Target Sample Size   Total Sample Size="1000"
Sample Size from India="1000" 
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)   13/01/2025 
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="2"
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  

·      Aim – To study the association between screen time and mental health wellness among different Deha Prakriti.

·      Objectives –

               i.         Primary Objectives –

–     To assess screen time, a validated screen time Performa will be used.

–     To assess mental health wellness, a validated DASS-21 Performa will be used.

–     To assess Prakriti, a validated Prakriti Performa will be used.

             ii.         Secondary Objectives –

–     To establish the association between screen time and mental health wellness among different Deha Prakriti types using a cross-sectional study methodology.

1. Outcome of Study:

·      This research will elucidate the role of Deha Prakriti in moderating the impact of screen time on mental health, thereby advancing the field of personalized medicine.

·      It will provide empirical evidence on how constitutional types influence mental health outcomes, leading to the development of individualized screen time management strategies and contributing to more precise and effective mental health interventions.

 
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