| CTRI Number |
CTRI/2025/05/086678 [Registered on: 09/05/2025] Trial Registered Prospectively |
| Last Modified On: |
17/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Immediate effect of breathing through a particular nostril on anxiety symptoms. |
|
Scientific Title of Study
|
IMMEDIATE EFFECTS OF YOGIC
UNILATERAL NOSTRIL BREATHING ON
PATIENTS WITH ANXIETY SPECTRUM
DISORDER |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sourindra Ta |
| Designation |
Post Graduate Student of M.Sc. Yoga Therapy (Mental Health and Neuroscience) |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCE |
| Address |
1st floor, Yoga Centre, Department of Integrative Medicine, Hosur Road, NIMHANS
Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
7063645885 |
| Fax |
|
| Email |
sourindrata@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Bhargav |
| Designation |
Associate Professor, Department of Integrative Medicine, NIMHANS, Bengaluru |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCE |
| Address |
G-13, Ground Floor, OPD Building, NIMHANS, Hosur Road, Bengaluru.
Bangalore
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Hemant Bhargav |
| Designation |
Associate Professor, Department of Integrative Medicine, NIMHANS, Bengaluru |
| Affiliation |
NATIONAL INSTITUTE OF MENTAL HEALTH AND NEUROSCIENCE |
| Address |
G-13, Ground Floor, OPD Building, NIMHANS, Hosur Road, Bengaluru.
Bangalore
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Mental Health And Neurosciences |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health And Neurosciences |
| Address |
Hosur Road, Bengaluru, 560029, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sourindra Ta |
National Institute of Mental Health and Neurosciences |
Assessment Room 1,
Department of Integrative Medicine, NIMHANS, Bangalore, KARNATAKA
Bangalore
KARNATAKA |
7063645885
sourindrata@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human ethics committee for research in AYUSH and integrative medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F40-F48||Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Yogic Unilateral Nostril Breathing.
Arm 1: Right Nostril Breathing
Arm 2: Left Nostril Breathing |
Arm 1: Patients will use a finger to close their left nostril and breathe through the right nostril for 10 minutes, once on a single day.
Arm 2: Patients will use a finger to close their right nostril and breathe through the left nostril for 10 minutes, once on a single day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Right-handed individuals diagnosed with Anxiety spectrum disorder in the age group of 18 to 55 years,
Sufficient cognition to follow commands; minimum educational qualification: 7th standard. |
|
| ExclusionCriteria |
| Details |
Abnormalities of the nasal cavity, such as nasal septal deviation or nasal polyps.
Use of medication that could influence autonomic function (e.g., phenylpropanolamine as a common cold remedy), any upper respiratory tract infection that could cause nasal blockage, Patients with only those cardiovascular and neurological disorders, where this Intervention is contraindicated. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To investigate the immediate effects of yogic unilateral nostril breathing on patients with anxiety spectrum disorder.
To identify potential correlations between specific unilateral nostril breathing patterns and corresponding hemispheric brain activity.
short version of the Spielberger State-Trait Anxiety Inventory (STAIS-5), Positive and Negative Affect Schedule (PANAS), Heart Rate Variability (HRV), and cognitive task—dual n-back task. |
Baseline, 5 minutes after intervention. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess whether practicing unilateral nostril breathing using the non-dominant nostril can influence nostril dominance. Nostril Dominance - Acoustic Rhino meter. |
Baseline, 5 minutes after intervention. |
|
|
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)
|
01/06/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Patients diagnosed with anxiety disorders are assessed for the severity of the disease. Patients are
randomized into two groups: the right nostril yogic breathing group and the left nostril yogic
breathing group. The duration of the intervention is 10 minutes. Assessments will be done at the
baseline and at the end of the intervention for those who are willing to participate in the
study. Safety assessments and adverse events will be monitored and appropriately
documented for the duration of the study period. The medications prescribed and taken by the
patients will be documented in both groups during the study period. Assessments are the short version of the Spielberger State-Trait Anxiety Inventory (STAIS-5), Positive and Negative Affect Schedule (PANAS), Nostril Dominance - Acoustic Rhino meter, Heart Rate Variability (HRV), and the Cognitive Task Dual N-Back Task. |