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CTRI Number  CTRI/2026/01/100280 [Registered on: 05/01/2026] Trial Registered Prospectively
Last Modified On: 05/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Ayurveda
Other (Specify) [Pranayam and relevant motivational videos]  
Study Design  Single Arm Study 
Public Title of Study   Attempt to Improve the capacity of First Year BAMS Students to handle stress 
Scientific Title of Study   Assessment and Management of stress in first year BAMS students. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vasudha Gajanan Asutkar 
Designation  Associate Professor 
Affiliation  Bharati vidyapeeth Deemed to be University College of Ayurveda Pune 
Address  Bharati Vidyapeeth Deemed to be University College of Ayurveda Student Support Carrier Guidance and Placement Cell New Building Third Floor
Bharati Vidyapeeth Deemed to be University College of Ayurveda Student Support Carrier Guidance and Placement Cell New Building Third Floor
Pune
MAHARASHTRA
411043
India 
Phone  9766571780  
Fax    
Email  vasudha.asutkar@bharatividyapeeth.edu  
 
Details of Contact Person
Scientific Query  
Name  Vasudha Gajanan Asutkar 
Designation  Associate Professor 
Affiliation  Bharati vidyapeeth Deemed to be University College of Ayurveda Pune 
Address  Bharati vidyapeeth Deemed to be University College of Ayurveda Student Support Carrier Guidence and Placement Cell New Building Third Floor
Bharati vidyapeeth Deemed to be University College of Ayurveda Student Support Carrier Guidence and Placement Cell New Building Third Floor
Pune
MAHARASHTRA
411043
India 
Phone  9766571780  
Fax    
Email  vasudha.asutkar@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Vasudha Gajanan Asutkar 
Designation  Associate Professor 
Affiliation  Bharati vidyapeeth Deemed to be University College of Ayurveda Pune 
Address  Bharati vidyapeeth Deemed to be University College of Ayurveda Student Support Carrier Guidence and Placement Cell New Building Third Floor
Bharati vidyapeeth Deemed to be University College of Ayurveda Student Support Carrier Guidence and Placement Cell New Building Third Floor
Pune
MAHARASHTRA
411043
India 
Phone  9766571780  
Fax    
Email  vasudha.asutkar@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Bharati vidyapeeth Deemed to be University College of Ayurveda Pune 
 
Primary Sponsor  
Name  NA 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 
Vasudha Gajanan Asutkar  Bharati vidyapeeth Deemed to be University College of Ayurveda Pune  Bharati vidyapeeth Deemed to be University College of Ayurveda Student Support Carrier Guidence and Placement Cell New Building Third Floor
Pune
MAHARASHTRA 		 09766571780

coayurved@bharatividyapeeth.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Deemed to be University Institutional Ethics Committe   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  STRESS  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmProcedure-satvAvajaya-cikitsA (Procedure Reference: Ashtanghriday Sutrasthana Adhyaya 2, Procedure details: Structured Ayurveda based intervention ,60 min session once a week for 1 month.)
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  22.00 Year(s)
Gender  Both 
Details  1st Year BAMS Students  
 
ExclusionCriteria 
Details  Unwilling to Enroll 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Categorization of 1st-year BAMS students into Low, Moderate, and High Stress groups based on PSS-10  After Intervention for 1 Month  
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   21/01/2026 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  the data will be available in the form of research article published in scientific journal

  6. For how long will this data be available start date provided 31-10-2026 and end date provided 02-01-1970?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Student support, carrier guidance and placement cell BVDUCOA aims to support students for their overall development and crises management. Our objectives include to render psychological support and being attentive towards mental well-being of the students. The studty includes entire batch of 100 students of 1st Year BAMS.The possible dropout rate is estimated to be 10 percentage. There is a genuine need to assess stress in 1st Year BAMS students as they face unique stressors like Transition from school to professional college life,academic pressure from Ayurveda texts in Sanskrit, language and communication barriers, hostel life and homesickness, Peer competition and self expectations.Hence early stress identification is key to preventing psychological burnout and improving academic performance.The Objectives of this study are to assess the stress in 1st year BAMS students,to give intervention to the students and assess the improvement and categorize students for further emotional and academic support,to initiate preventive mental health and wellness programs based on findings.Study methodology includes Phase 1 is Observational phase which includes Pre assessment of study participants for PSS 10.Assessment of PSS 10 score for the gradation of stress score as low 0 to 13, moderate14 to 26 and high 27 to 40 and Differentiation of participants for structured intervention and for one to one sessions for psychological support. Phase 2 is the Interventional phase. Which includes exclusion of the high PSS Score participants and exposure to Integrated Intervention using validated stress scalePSS10 and Structured Ayurveda based intervention ,60 min session once a week for 1 month. Step 1 is orientation regarding Pranayam as a logical motivational technique to overcome stress. Step 2 is presenting to the study participants motivational videos, to reduce stress in a unique way by unfolding concepts of the correct code of conduct for targeted aim of this study . For this a Revealing video of Happy Thoughts Tej Gyana Foundation available free on You-tube will be used. Phase 3 is Post Interventional assessment of study participants for PSS10. 
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