| CTRI Number |
CTRI/2025/04/084183 [Registered on: 04/04/2025] Trial Registered Prospectively |
| Last Modified On: |
04/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Nasal breathing pattern as an Assessment Tool for disease severity in Common Mental Disorders |
|
Scientific Title of Study
|
Clinical utility of Prana Reset Time while imparting Yoga therapy for Common Mental Disorders |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vibha S Gupta |
| Designation |
Post Graduate student |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative medicine, NIMHANS, Hosur road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
7353535606 |
| Fax |
|
| Email |
vibhasgupta6@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hemant Bhargav |
| Designation |
Associate proffessor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative medicine, 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 proffessor |
| Affiliation |
National Institute of Mental Health and Neurosciences |
| Address |
Department of Integrative medicine, NIMHANS, Hosur road, Bengaluru
Bangalore
KARNATAKA
560029
India |
| Phone |
8762019348 |
| Fax |
|
| Email |
drbhargav.nimhans@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institue of Mental Health and Neurosciences, Hosur road, Bengaluru - 560029, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
National Institute of Mental Health and Neurosciences |
| Address |
Hosur road, Bengaluru, 560029 |
| Type of Sponsor |
Research institution and hospital |
|
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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 Hemant Bhargav |
National Institute of Mental Health and Neuro Sciences |
Room no 1, first floor, yoga centre building, department of Integrative Medicine, NIMHANS, Bengaluru, 560029, Karnataka, India
Bangalore
KARNATAKA |
8762019348
drbhargav.nimhans@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 |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: F209||Schizophrenia, unspecified, (2) ICD-10 Condition: F429||Obsessive-compulsive disorder, unspecified, (3) ICD-10 Condition: F411||Generalized anxiety disorder, (4) ICD-10 Condition: F339||Major depressive disorder, recurrent, unspecified, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with depression, anxiety, Obsessive Compulsive Disorder, Schizophrenia according to DSM5 and Healthy individuals with GHQ-12 score equal to or less than 12 of both genders who has given written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patients not willing to give informed consent.
2. Abnormalities of the nasal cavity such as nasal septal deviation or nasal polyps.
3. Use of medication that could influence autonomic function (e.g., phenylpropanolamine as a common cold remedy).
4. Any upper respiratory tract infection that could cause nasal blockage
5. History of current medical illness that may significantly affect brain functions
6. Impaired general intellectual functioning (Mini-Mental Status Exam, MMSE below 24).
7. Past history of head injury or concomitant severe medical conditions.
8. Pregnant or post-partum subjects
|
|
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Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare PRT in the healthy individuals and patients suffering from CMDs (anxiety, depression, obsessive compulsive disorder and schizophrenia) and to correlate PRT and the severity of common mental diseases |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To check the test retest reliability of PRT |
Baseline |
| To assess the correlation between subjective feeling and objective score of nasal dominance (as assessed by acoustic rhinometer) |
Baseline |
| To check the effect of 1 week practice of respective validated yoga modules on the prana reset time and clinical course |
Baseline and 1 week of follow up |
|
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Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
01/05/2025 |
| 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 Yet Recruiting |
| 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
|
This study explores the clinical utility of Prana Reset Time (PRT) as an assessment tool while imparting yoga therapy for common mental disorders. A total of 240 participants will be recruited, including 120 healthy volunteers and 120 patients diagnosed with depression (30), OCD (30), schizophrenia (30), and anxiety disorders (30). Study Design Patients will be assessed for disease severity, while healthy individuals will be evaluated for general health. The study will include: 1. Nasal Dominance Assessment: Initially assessed subjectively, then confirmed using an acoustic rhinometer. 2. Prana Reset Time (PRT) Measurement: Participants will perform 15 sets of forward and backward bends, after which nasal dominance will be periodically reassessed until it returns to baseline. The time taken for restoration will be recorded. The entire set will be repeated. 3. Yoga Intervention: n/3 patients will practice their respective validated yoga module for one week. 4. Safety and Medication Monitoring: Any adverse events will be documented, and medications prescribed and taken by both groups will be recorded throughout the study. The study will evaluate PRT and its correlation with disease severity using standardized psychological and clinical assessment tools, including: 1. Perceived Stress Scale (PSS) 2. Hamilton Anxiety Rating Scale (HAM-A) 3. Hamilton Depression Scale (HAM-D) 4.Yale-Brown Obsessive-Compulsive Scale (YBOCS) 5. Brief Psychiatry Rating Scale (BPRS) 6. General Health Questionnaire (GHQ-12) 7. Clinical Global Impression Scale – Severity of Illness (CGI-S) By analysing these parameters, the study aims to determine whether PRT can serve as a reliable physiological marker for assessing the severity of mental health disorders. Findings from this research may contribute to integrating yoga-based assessments into clinical practice for better mental health management.
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