| CTRI Number |
CTRI/2025/07/090257 [Registered on: 07/07/2025] Trial Registered Prospectively |
| Last Modified On: |
05/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Nadanusandana and Breath Awareness: Effects on Stress and Cognitive functions in Students |
|
Scientific Title of Study
|
Effect of Nadanusandana Versus Normal Breath Awareness on Stress and Cognitive Function in Students - A Comparative 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 Sayapogu Maha Swetha |
| Designation |
MD Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic sciences |
| Address |
Department of Yoga and Therapeutics, SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka, India.
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8106183629 |
| Fax |
|
| Email |
dr.mahaswetha1029@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sayapogu Maha Swetha |
| Designation |
MD Scholar |
| Affiliation |
SDM College of Naturopathy and Yogic sciences |
| Address |
Department of Yoga and Therapeutics, SDM College of Naturopathy and Yogic Sciences, Ujire, Dakshina Kannada, Karnataka, India.
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8106183629 |
| Fax |
|
| Email |
dr.mahaswetha1029@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivaprasad Shetty |
| Designation |
Dean & Professor |
| Affiliation |
SDM College of Naturopathy and Yogic sciences |
| Address |
Department of Yoga Therapeutics, SDM College of Naturopathy and Yogic Sciences, Ujire, Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9731854585 |
| Fax |
|
| Email |
drshivapshetty70@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM Educational Institutions, uijre, Belthangady, Dakshina kannada,karnataka - 574240 |
|
|
Primary Sponsor
|
| Name |
Dr Sayapogu Maha Swetha |
| Address |
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangady, Dakshina Kannada, Karnataka, India 574240 |
| Type of Sponsor |
Other [Self] |
|
|
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 SAYAPOGU MAHA SWETHA |
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital, shantivana |
Center of Excellence, SDM Yoga and Nature Cure Hospital,
Shantivana,
Dharmasthala, Dakshina
Kannada, Karnataka,
India - 574216
Dakshina Kannada
KARNATAKA |
08106183629
dr.mahaswetha1029@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
stress and cognition
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nadanusandana |
subjects will undergo Nadanusandana (it is the practice of meditative absorption through inner sound (Nada). It involves focusing the mind on subtle internal sounds heard during deep meditation, such as those resembling a bell, flute, or bee. This inward concentration leads to the withdrawal of the senses (pratyahara), calming of the mind, and eventually to deep meditative absorption (laya) and liberation (samadhi). It is considered a powerful method for attaining inner stillness and spiritual awakening) as technique four times in a week of duration 25-30 minutes for
a period of 1 month. |
| Comparator Agent |
Normal Breath Awareness |
subjects will undergo Normal Breath Awareness ( it is a simple yet powerful mindfulness practice that involves observing the natural flow of breath without altering it. Practiced in a relaxed seated posture with eyes closed, attention is gently placed on the inhalation and exhalation, promoting present-moment awareness and reducing mental distractions. This non-judgmental observation of breath helps calm the nervous system, reduce stress, and improve focus and emotional regulation. It serves as a foundational practice in many mindfulness and yoga traditions, supporting both mental clarity and inner peace) as Technique four times in a week of Duration 25-30 minutes for a period of 1 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who has moderate to severe stress screened by using Cohen’s perceived stress scale. |
|
| ExclusionCriteria |
| Details |
Students who are consuming nicotine and alcohol
Weak and debilitating individuals.
Systemic illness
Sciatica
Ear infections |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Autonomic function using heart rate variability, auditory reaction time. |
Pre & Post |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Stress using perceived stress scale.
Cognitive function by using digit symbol substitution test. |
Pre & Post |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="1"
Months="0"
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
|
Stress is a state of disharmony or threatened homeostasis, living beings survive by maintaining
a complex dynamic and harmonious equilibrium, or homeostasis that is constantly challenged
or threatened by intrinsic or extrinsic disturbing forces which can be called as stressors and the
steady state required for good adaption over them is maintained by mental reactions that
attempt to counteract in order to re-establish homeostasis. Based on viability and duration
of stressor, stress is classified in to acute stress which is termed as body’s immediate reaction
to stressor, episodic stress where acute stress is seen frequently and chronic stress which is
caused by unresolved and long lasting stressors. About 41 million (71%) of the 55 million deaths that occurred globally were related to
NCDs and stress is known to be major contributing factor for it. Hatha
Yoga, which has its roots in ancient India, is a holistic approach to body, mind, and soul
purification. This study examines the effect of yoga on stress reduction and improved
cognitive functions. |