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CTRI Number  CTRI/2024/07/070437 [Registered on: 10/07/2024] Trial Registered Prospectively
Last Modified On: 09/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of Cold Spinal Spray and Cold Spinal Bath on Cognition Among Young Adults 
Scientific Title of Study   Immediate Effect of Cold Spinal Spray and Cold Spinal Bath on Cognition Among Young Adults: A Three-Arm Randomized Controlled Trial 
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 Avishee Sinha 
Designation  MD Scholar  
Affiliation  SDM College of Naturopathy and Yogic Sciences 
Address  Department of Natural Therapeutics, SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka, India - 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9980132964  
Fax    
Email  avishee.sinha.16@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Avishee Sinha 
Designation  MD Scholar  
Affiliation  SDM College of Naturopathy and Yogic Sciences 
Address  Department of Natural Therapeutics, SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka, India - 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9980132964  
Fax    
Email  avishee.sinha.16@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sujatha K J 
Designation  Dean Division of Natural Therapeutics and Vice Principal 
Affiliation  SDM College of Naturopathy and Yogic Sciences 
Address  Department of Natural Therapeutics, SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka, India - 574240

Dakshina Kannada
KARNATAKA
574240
India 
Phone  9480401646  
Fax    
Email  drsujathadinesh2@gmail.com  
 
Source of Monetary or Material Support  
Sri Dharmasthala Manjunatheshwara Ypga and Nature Cure Hospital, Shantivana, Dharmasthala, Belthangadi, Dakshina Kannada, Karnataka, India - 574240 
 
Primary Sponsor  
Name  Dr Avishee Sinha 
Address  SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangadi, Dakshina Kannada, Karnataka, India - 574240 
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 
Dr Avishee Sinha  Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital, Shantivana  COE, Department of Natural Therapeutics, Shantivana, Dharmasthala, Belthangadi, Dakshina Kannada, Karnataka, India - 574240
Dakshina Kannada
KARNATAKA 		 7338045113

avishee.sinha.16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Not Applicable 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cold Spinal Bath  subjects will receive Cold Spinal Bath for 15 mins only one time 
Intervention  Cold Spinal Spray  subjects will receive cold spinal spray for 15 mins only one time 
Comparator Agent  supine rest  subjects will undergo supine rest for 15 mins only one time 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  30.00 Year(s)
Gender  Both 
Details  Subjects who are willing to participate in the study 
 
ExclusionCriteria 
Details  1. Weak and debilitating individuals
2. Systemic illness
3. Subjects with open wounds
4. Had caffeine 24 hours before
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Stroop test
2. Letter Digit Substitution Test
3. Sternberg test  		 pre, post 
 
Secondary Outcome  
Outcome  TimePoints 
Heart rate variability  pre, post 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="30" 
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   Phase 2 
Date of First Enrollment (India)   01/12/2024 
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="0"
Months="3"
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 - NO
Brief Summary     Cognition is the indisputable process of acquiring knowledge and superior understanding through unwavering thought, immersive experiences, and keen senses. However, several noncognitive factors, such as motivation and mood, can impact the performance of these cognitive domains. Naturopathic medicine is a whole system of Complementary and Alternative Medicine most closely resembling conventional primary care but with greater delivery of healthy lifestyle counseling. Naturopathic treatments like Spinal bath which is a non-pressurized hydatic treatment in which water of a specific temperature is applied to the spinal area for a certain amount of time in order to achieve desired effects and Spinal spray which circulate cold, neutral and hot water according to different temperature as requirement for patients are extensively used in naturopathy to treat various disease conditions. Although, spinal spray and spinal bath are extensively used in naturopathy to treat various disease conditions, their specific physiological effects on cognition have not yet been studied in healthy individuals Thus, present study focuses on the effect of Cold spinal spray and Cold spinal bath on cognition (working memory and short-term memory) in healthy volunteers.  
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