Effect of nostril breathing patterns in the patients of Major Depressive Disorder.

Phase 1/2

Not yet recruiting

Conditions: Major depressive disorder, singleepisode, moderate,

Registration Number: CTRI/2023/12/060900

Lead Sponsor: Indian Council of Medical Research, New Delhi

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 patientâ€™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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

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.

Exclusion Criteria

H/O any psychiatric disorder other than depression 2.
H/O substance abuse 3.
Pregnancy 4.
Chronic physical illnesses (excluded based on clinical history.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
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

Trial Locations

Locations (1): AIIMS New Delhi
🇮🇳
Delhi, DELHI, India
AIIMS New Delhi
🇮🇳Delhi, DELHI, India
Dr Prashant Tayade
Principal investigator
9911794911
dr.prashanttayade@gmail.com