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CTRI Number  CTRI/2025/03/081794 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 31/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Crossover Trial 
Public Title of Study   Evaluating the Effect of Cold Spinal Spray in Sitting and Cold Spinal Spray in lying on Autonomic Variables and Reaction time in Healthy individual- A Comparative cross-over study 
Scientific Title of Study   Evaluating the effect of Cold Spinal Spray in Sitting and Cold Spinal Spray in lying on Autonomic Variables and Reaction time in Healthy individuals-A Comparative cross-over 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  Dr Ayswarya Rohini Pandian 
Designation  PG Scholar 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  International Institute of Yoga and Naturopathy Yogic Sciences, Kamarajar Nagar, Chengalpattu-603001, Tamil Nadu
RKNCH, No 12, Krishna layout, Ganathypudhur
Coimbatore
TAMIL NADU
603001
India 
Phone  7902623119  
Fax    
Email  drayswaryarp90@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Pandiaraja Muthupandi 
Designation  HOD i/c 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  International Institute of Yoga and Naturopathy Yogic Sciences, Kamarajar Nagar, Chengalpattu-603001, Tamil Nadu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9952448729  
Fax    
Email  drpandiarajamuthupandimd@gmail.com  
 
Details of Contact Person
Public Query  
Name  Mr Gopalakrishnan 
Designation  Retired Chartered Accountant 
Affiliation  International Institute of Yoga and Naturopathy Medical Sciences 
Address  E3 gitalaya, 7th street, Dr Radhakrishnan salai, Mylapore, Chennai

Chennai
TAMIL NADU
600004
India 
Phone  9677291016  
Fax    
Email  Ggopal1954@gmail.com  
 
Source of Monetary or Material Support  
International Institute of Yoga and Naturopathy Medical Sciences Outpatient department  
 
Primary Sponsor  
Name  Dr Ayswarya Rohini Pandian 
Address  International Institute of Yoga and Naturopathy Yogic Sciences, Kamarajar Nagar, Chengalpattu-603001, Tamil Nadu 
Type of Sponsor  Government 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 M Pandiaraja  International Institute of Yoga and Naturopathy Medical Sciences  Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU 		 9952448729

drpandiarajamuthupandimd@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee- IIYNMS   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cold Spinal Spray  Lying 
Comparator Agent  Cold Spinal Spray  Sitting/lying 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  35.00 Day(s)
Gender  Both 
Details  Age between 18-35
Both male and female
Subjects who are willing to participate under above criteria
Normotensive subjects from the identified sample 
 
ExclusionCriteria 
Details  Subjects with known case of Hypertension
Women during pregnancy and lactation
Female subjects on menstruation- it is possible that female participants may fall under exclusion criteria during cross over
subjects with other co-morbidities
subjects with recent surgery
subjects below 18 and 35 years of age
subjects under any kind of regular medications
subjects with recent spinal injuries, spinal fracture, epidural injections or spinal surgery (within 6 months from the date of sampling)
subjects with back pain associated with lumbar spondylosis, spondylolisthesis or any arthropathies.
Subjects with other morbidities, Subjects with recent surgery
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Autonomic variables   Baseline (T0)
Post intervention (T1) 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the variationin cardiac functions-Blood pressure, respiratory rate, and heart rate variability in healthy individuals
Reaction time 		 0-15 days 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/03/2025 
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="1"
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 - 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 - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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) -  open access

  6. For how long will this data be available start date provided 25-01-2025 and end date provided 25-04-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A comparative cross-over study on evaluating the effect of cold spinal spray in sitting and lying(10 minutes) on Autonomic variables and reaction time in Healthy individuals (18-35years) . The cross over will be done after 15 days of intervention. Base line and post intervention assessment data will be statistically analyses using SPSS software latest version. 
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