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CTRI Number  CTRI/2025/02/080941 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 12/02/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Relationship between body constitution and brain functions 
Scientific Title of Study   A Cross-sectional study to explore the relationship between Prakriti and Autonomic Variability with special reference to Sympathetic Nervous System among Ayurveda undergraduate 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  Srushti Krishna Patil 
Designation  Student(BAMS 1st Profession) 
Affiliation  Shri Dharmasthala Manjunatheshwara institute of Ayurveda and Hospital,Bengaluru, 
Address  I Professional BAMS student 2023-2024 Batch, Department of Kriya Sharir,Shri Dharmasthala Manjunatheshwara institute of Ayurveda and Hospital,Bengaluru

Bangalore
KARNATAKA
560074
India 
Phone  9632377611  
Fax    
Email  srushtirupapatil96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Resmy Raj A 
Designation  Assistant Professor 
Affiliation  Shri Dharmasthala Manjunatheshwara institute of Ayurveda and Hospital,Bengaluru, 
Address  Department of Kriya Sharir,SDM Institute of Ayurveda and Hospital,Anchepalya,Kumbalagodu Post,Banglore Mysore Highway

Bangalore
KARNATAKA
560074
India 
Phone  9995011751  
Fax    
Email  resmyraj.bala@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Resmy Raj A 
Designation  Assistant Professor 
Affiliation  Shri Dharmasthala Manjunatheshwara institute of Ayurveda and Hospital,Bengaluru, 
Address  Department of Kriya Sharir,SDM Institute of Ayurveda and Hospital,Anchepalya,Kumbalagodu Post,Banglore Mysore Highway

Bangalore
KARNATAKA
560074
India 
Phone  9995011751  
Fax    
Email  resmyraj.bala@gmail.com  
 
Source of Monetary or Material Support  
CCRAS,61-65, opp. D’ Block, D Block, Janakpuri Institutional Area, Janakpuri, New Delhi, Delhi 110058 Telephone : 91-011-28525862/28525897/28525852  
 
Primary Sponsor  
Name  CCRAS 
Address  Janaki Pura,New Delhi,110058 
Type of Sponsor  Other [Autonomous Government] 
 
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 Resmy Raj A  Institute of Ayurveda and Hospital  Department of Kriya Sharir,SDM Institute of Ayurveda and Hospital,Anchepalya,Kumbalagodu Post,Baangalore Mysore Highway Anchepalya,Kumbalagodu Post
Bangalore
KARNATAKA 		 09995011751

resmyraj.bala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy human subject of 18-20 years old with no ANS dysfunction 
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  20.00 Year(s)
Gender  Both 
Details  Both Gender,18-20 years age ,Willing to participate in study 
 
ExclusionCriteria 
Details  Who are on medication for acute or chronic illness,Who reported autonomic dysfunction disorders,who has orthostatic hypotension,Who are not able to immerse hand in cold water(4-8 degree celsius) for 1 minute 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Relationship between Prakruti and Sympathetic variability to be checked  Baseline (Prakruti and autonomic functions are checked) 
 
Secondary Outcome  
Outcome  TimePoints 
Stress evaluation with ANS function  Baseline 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   23/02/2025 
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="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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  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 - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [resmyraj.bala@gmail.com].

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2028?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  
72 healthy volunteers who fulfils the inclusion criteria will be selected by simple random sampling from study
setting. Written informed consent will be taken. Demographic characteristics will be collected. Prakriti
assessment will be done with CCRAS Ayur Prakriti Web Portal and stress will be measured through PSS 10.
Sympathetic nervous system function assessed with provocative tests like handgrip dynamometer test, cold
pressor test and lying to standing tests. The relationship of all these parameters with prakriti and stress will be
analyzed through proper statistical tests by SPSS software 16(:233 South Wacker Drive, 11th Floor, Chicago,
trademarks of Apple Computer, Inc., registered in the U.S.)
 
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