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CTRI Number  CTRI/2024/05/067417 [Registered on: 15/05/2024] Trial Registered Prospectively
Last Modified On: 20/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   How Cooling pranayamas affect Saliva in Stressed Young Adults 
Scientific Title of Study   EFFECT OF COOLING PRANAYAMA ON SALIVARY pH AND SALIVARY FLOWRATE IN YOUNG ADULTS WITH PERCEIVED STRESS: A RANDOMIZED CONTROL TRIAL 
Trial Acronym  RCT 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vinaya Kumar T 
Designation  PG Scholar 
Affiliation  Alvas College of Naturopathy and Yogic Sciences 
Address  Room no- 07, Department of Clinical Yoga,Alvas College of Naturopathy and Yogic Sciences, Mijar, Moodbidri

Dakshina Kannada
KARNATAKA
574225
India 
Phone  9482421906  
Fax    
Email  drvinayktbhat@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Archana K 
Designation  Professor, HOD of Yoga Department 
Affiliation  Alvas College of Naturopathy and Yogic Sciences 
Address  Room no- 07, Department of Clinical Yoga,Alvas College of Naturopathy and Yogic Sciences, Mijar, Moodbidri

Dakshina Kannada
KARNATAKA
574225
India 
Phone  9448152915  
Fax    
Email  dr.archanabnys@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Sharada Shetty P S 
Designation  Assistant Professor, Department of Yoga 
Affiliation  Alvas College of Naturopathy and Yogic Sciences 
Address  Room no- 07, Department of Clinical Yoga,Alvas College of Naturopathy and Yogic Sciences, Mijar, Moodbidri

Dakshina Kannada
KARNATAKA
574225
India 
Phone  8748971865  
Fax    
Email  shettysharada96@gmail.com  
 
Source of Monetary or Material Support  
Alvas College Of Naturopathy And Yogic Sciences, Mijar, Moodbidri, Dakshina Kannada, Karnataka , India - 574225 
 
Primary Sponsor  
Name  Dr Vinaya Kumar T 
Address  Alvas College Of Naturopathy And Yogic Sciences, Mijar, Moodbidri, Dakshina Kannada, Karnataka, India - 574225 
Type of Sponsor  Other [Self Sponser] 
 
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 Vinaya Kumar T  Alvas Education Foundation  Room no. 7, Department of Yoga, Shobhavana Campus, Mijar, Moodbidre 574225
Dakshina Kannada
KARNATAKA 
9482421906

drvinayktbhat@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee for Human Studies of Alvas College of Naturopathy and Yogic Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Perceived stress 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Cooling Pranyama - Sheetali and Shitkari.  Cooling pranayama is given to the perceived stress young adults, 6 days in a week for 21 days in the evening. Subjects receive each pranayama for 10 minutes with 2 minutes break between the practice. 
Comparator Agent  No intervention- will be asked to follow daily routine  Control group is not given any interventions but they are asked to follow the daily routine what they were following earlier. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  25.00 Year(s)
Gender  Both 
Details  1. Young Adults both males and females of age group between 18-25 years old.
2. With moderate to severe perceived stress scores.
3. Subjects who are willing and given the consent for receiving the intervention. 
 
ExclusionCriteria 
Details  1. Habit of alcohol consumption, smoking and areca chewing.
2. History of trauma to the head and neck.
3. Denture wearers.
4. History of radiotherapy.
5. Individuals with systemic or salivary gland diseases or under any drug therapy.
6. Individuals with any lesions in the oral cavity.
7. Disease of oesophagus, stomach, and intestine.
8. Those who had past exposure to pranayama or yoga therapy from last 6 months. 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Salivary pH and Salivary flowrate in ml  Assessments done at two time points:
1. Pre-assessment - Day 0- Before giving the intervention.
2. Post-assessment - Day 21 - After 3 weeks of Intervention. 
 
Secondary Outcome  
Outcome  TimePoints 
Perceived Stress  1st day of intervention and
on 21st day of intervention. 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   15/11/2024 
Date of Study Completion (India) 31/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
The term "stress" refers to the physical, emotional, cognitive, and behavioral reactions to situations that are perceived as challenging or threatening. Recently statistical data show the incidence of stress is high among the young adults. Yoga is an age-old practice that is considered an integral part of one’s daily life in this modern world and many practice it regularly across the globe. There are Eight Limbs in Ashtanga Yoga systematized by Maharshi Patanjali. One among them is Pranayama. Maharshi Patanjali States Pranayama as तस्मि न्सतिश्वासप्रश्वासयोर्गतिविच्छेदःप्राणायामः – regulating or transcending the movement of inhalation and exhalation is known as pranayama. Thus, yoga and pranayama help individuals cope with the stress they face in their daily life situations. Earlier studies using cooling pranayama were done on stress, autonomic variables, pulmonary function, etc… but not on salivary flowrate and salivary ph or on oral health. Therefore, the present study aims to measure the effect of cooling pranayamas on salivary pH and salivary flow rate in individuals with perceived stress.
This study aims to assess the effect of cooling pranayama on salivary pH and salivary flow rate among young adults of both genders of age group 18 -25 years with perceived stress. A total sample of 90 subjects will be included after screening and randomly divided into 2 groups where the study group (n=45) will be given cooling pranayama and the control group (n=45) will be asked to follow their routine for a period of 21 days. Assessments will be recorded in the baseline (Day 0) and post-intervention (Day 21). 
 
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