| 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
|
|
|
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
|
|
|
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 तसà¥à¤®à¤¿ नà¥à¤¸à¤¤à¤¿à¤¶à¥à¤µà¤¾à¤¸à¤ªà¥à¤°à¤¶à¥à¤µà¤¾à¤¸à¤¯à¥‹à¤°à¥à¤—तिविचà¥à¤›à¥‡à¤¦à¤ƒà¤ªà¥à¤°à¤¾à¤£à¤¾à¤¯à¤¾à¤®à¤ƒ – 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). |