| CTRI Number |
CTRI/2023/12/060900 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
28/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of nostril breathing patterns in the patients of Major Depressive Disorder. |
|
Scientific Title of Study
|
Effect of nostril breathing patterns in the patients of Major Depressive Disorder. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Prashant Tayade |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room 6016, convergence Block, Department of Physiology,
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9911794911 |
| Fax |
|
| Email |
dr.prashanttayade@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashant Tayade |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room 6016, convergence Block, Department of Physiology,
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9911794911 |
| Fax |
|
| Email |
dr.prashanttayade@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prashant Tayade |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room 6016, convergence Block, Department of Physiology,
AIIMS New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9911794911 |
| Fax |
|
| Email |
dr.prashanttayade@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research, New Delhi |
|
|
Primary Sponsor
|
| Name |
Indian Council of Medical Research, New Delhi |
| Address |
Ansary Nagar, New Delhi, 110029. |
| Type of Sponsor |
Government funding agency |
|
|
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 Prashant Tayade |
AIIMS New Delhi |
Room-6010, Department of Physiology, AIIMS New Delhi
New Delhi
DELHI |
9911794911
dr.prashanttayade@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee (IEC) AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F321||Major depressive disorder, singleepisode, moderate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healthy controls undergoing Alternate nostril breathing protocol. |
The Alternate nostril breathing protocol will be given to healthy controls for 2 weeks initially as offline. After this online Alternate nostril breathing will be monitored online by expert from integrated Health clinic Lab. The ANB protocol will be conducted daily single session of 27 to 30 min in IHC lab, Department of Physiology, AIIMS, New Delhi. Each session will be structured as; 5min relaxed instruction followed by 15 min of ANB protocol which will be followed by 5 min rest. The healthy controls will be instructed to sit comfortably with the preferably spine erect. The cross-legged posture used traditionally will be avoided for any possible discomfort in the depression patients. The exercise will begin with initial exhalation by both the nostrils, followed by closing the right nostril with the thumb of right hand. The subjects will then inhale slowly through the left nostril. After complete inhalation, the left nostril will be closed with the help of little and ring fingers of right hand which followed by the opening of the right nostril and exhaling through right nostril. The subjects will then inhale through the right nostril followed by exhalation through the left nostril. This will be one round, which will be continued for 15 minutes. The subjects will be instructed to close their eyes and their attention be focused on their breath. |
| Comparator Agent |
Healthy controls undergoing Single Nostril Breathing |
SNB protocol will be performed in SCEL lab and EEG will be acquired throughout the protocol. During the recording, healthy subjects will be seated comfortably. 128 channel HydroCel Geodesic Sensor net (HCGSN) will be placed over their scalp for recording EEG. A resting EEG record of 5 minutes in spontaneous breathing will be taken. During spontaneous breathing nostril dominance will be determined with the help of nasal thermistor assessing the nasal air flow at baseline. After this, the subject will be randomly allocated either of the sequence of sessions i.e. right nostril breathing first followed by left nostril breathing or left nostril breathing followed by right nostril breathing. The two unilateral breathing sessions will be separated by 5 minutes of spontaneous breathing. EEG will be recorded continuously during the above task. |
| Intervention |
MDD patients undergoing Alternate nostril Breathing |
The Alternate nostril breathing protocol will be given offline to the MDD conventional therapy undergoing ANB group for 2 weeks initially. After this online Alternate nostril breathing will be monitored online by expert from integrated Health clinic Lab. The ANB protocol will be conducted daily single session of 27 to 30 min in IHC lab, Department of Physiology, AIIMS, New Delhi. Each session will be structured as; 5min relaxed instruction followed by 15 min of ANB protocol which will be followed by 5 min rest. The patients will be instructed to sit comfortably with the preferably spine erect. The cross-legged posture used traditionally will be avoided for any possible discomfort in the depression patients. The exercise will begin with initial exhalation by both the nostrils, followed by closing the right nostril with the thumb of right hand. The subjects will then inhale slowly through the left nostril. After complete inhalation, the left nostril will be closed with the help of little and ring fingers of right hand which followed by the opening of the right nostril and exhaling through right nostril. The subjects will then inhale through the right nostril followed by exhalation through the left nostril. This will be one round, which will be continued for 15 minutes. The subjects will be instructed to close their eyes and their attention be focused on their breath. |
| Comparator Agent |
MDD patients undergoing conventional treatment |
MDD patients undergoing conventional treatment without any intervention for 3 months as a parallel group for Alternate nostril group. |
| Intervention |
MDD patients undergoing Single Nostril Breathing |
SNB protocol will be performed in SCEL lab and EEG will be acquired throughout the protocol. During the recording, Mild MDD patients/subjects will be seated comfortably. 128 channel HydroCel Geodesic Sensor net (HCGSN) will be placed over their scalp for recording EEG. A resting EEG record of 5 minutes in spontaneous breathing will be taken. During spontaneous breathing nostril dominance will be determined with the help of nasal thermistor assessing the nasal air flow at baseline. After this, the subject will be randomly allocated either of the sequence of sessions i.e. right nostril breathing first followed by left nostril breathing or left nostril breathing followed by right nostril breathing. The two unilateral breathing sessions will be separated by 5 minutes of spontaneous breathing. EEG will be recorded continuously during the above task. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults with clinically diagnosed major depressive disorder (MDD) as per DSM-V criteria
2. Either gender
3. Age between 18-45 years
4. Right-handed subjects
5. Subject should be able to give informed consent.
6. No prior exposure to yoga practices
|
|
| ExclusionCriteria |
| Details |
H/O any psychiatric disorder other than depression
2. H/O substance abuse
3. Pregnancy
4. Chronic physical illnesses (excluded based on clinical history
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Alternate Nostril breathing (ANB) will induce demarcating brain changes in MDD conventional therapy group in terms of QEEG parameters as EEG microstates (mean duration, time coverage, GEV) and Source connectivity, along with fMRI- ROL(region of interest) and network activity, which will be distinct from conventional therapy MDD group as well as the normal controls. |
3 months after ANB |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SNB will induce significant changes in MDD patients as compared to healthy controls in EEG microstates and Sources, stress and inflammatory markers |
same day pre and post test |
| ANB will induce significant changes in MDD patients as compared to MDD conventional therapy patients and healthy controls in stress and inflammatory markers |
3 months after ANB |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
02/01/2024 |
| 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="3"
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
|
Rationale/ gaps in existing knowledge: Effect of Nostril breathing patterns as Anulom vilom pranayama (ANB) and Single nostril breathing (SNB) are not tested as inducing improvement or changes in MDD patient’s stress levels. The Neural correlates along with autonomic and inflammatory markers due to the effect of Alternate nostril breathing (Anulom vilom pranayama) and Single nostril breathing on Major Depression patients (MDD) as compared to MDD on conventional therapy have not been demarcated and identified. Novelty: This is the first study that aims to identify the Neural, autonomic, and inflammatory markers as well as understand the mechanism (considering the holistic brain markers view) due to the effect of Single and Alternate nostril breathing on patients of Major Depressive disorders. (MDD) Objectives: 1. To compare the Neural correlates between following; a. MDD patients on conventional therapy undergoing ANB and MDD on conventional therapy. b. MDD patients on conventional therapy undergoing ANB and healthy controls undergoing ANB. 2. To Compare the QEEG correlates of Mild MDD patients exposed to SNB and normal subjects exposed to SNB (left nostril and right nostril separate) 3. Study the Stress, inflammatory markers in, MDD conventional therapy with ANB, MDD conventional therapy and healthy controls with ANB; SNB on Mild MDD patients and healthy controls. . a. Stress parameters HRV, GSR b. Inflammatory markers (TNF, IL6, CRP) c. ACTH, cortisol (serum) d. BDNF Expected outcome. 1. Neural markers in terms of QEEG and fMRI along with stress and inflammatory markers will be distinctly delineated in the MDD conventional therapy undergoing ANB as compared to MDD on conventional therapy and Healthy controls as well. 2. Distinct QEEG, autonomic and inflammatory markers will be identified in SNB effect on Mild MDD as compared to Normal subjects. |