| CTRI Number |
CTRI/2024/02/063230 [Registered on: 28/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of breathing techniques in stress management in police personnel |
|
Scientific Title of Study
|
Effect of bhramari pranayam in stress management in police personnel |
| 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 Mayuri Manoj Chavan |
| Designation |
PG Scholar |
| Affiliation |
Bharti Vidyapeeth Deemed to be University College of Ayurved Pune |
| Address |
Department of Swasthavritta and Yoga Bharati Vidyapeeth Deemed to be University College of Ayurved Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9637597696 |
| Fax |
|
| Email |
chavanmayurim@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirti Bhati |
| Designation |
Professor |
| Affiliation |
Bharti Vidyapeeth Deemed to be University College of Ayurved Pune |
| Address |
Department of Swasthavritta and Yoga Bharati Vidyapeeth Deemed to be University College of Ayurved Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9423010166 |
| Fax |
|
| Email |
kirti.bhati@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirti Bhati |
| Designation |
Professor |
| Affiliation |
Bharti Vidyapeeth Deemed to be University College of Ayurved Pune |
| Address |
Department of Swasthavritta and Yoga Bharati Vidyapeeth Deemed to be University College of Ayurved Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9423010166 |
| Fax |
|
| Email |
kirti.bhati@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth deemed to be University college of Ayurved and Hospital Pune |
|
|
Primary Sponsor
|
| Name |
Dr Mayuri Manoj Chavan |
| Address |
Swasthavritta Evum Yoga OPD, ground floor room no- 15, Bharati Vidyapeeth (deemed to be0 University College of Ayurved and Hospital, Pune-Satara road, Pune-43 |
| 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 |
| Mayuri Manoj Chavan |
Bharati vidyapeeth deemed to be university college of Ayurved and Hospital Pune |
Bharati vidyapeeth deemed to be university Ayurved Hospital Swasthavritta opd nn 15 ground floor Katraj Dhankawadi Pune
Pune
MAHARASHTRA |
9637597696
chavanmayurim@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| BV(DU)COA Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Mentally stressed individual |
| Patients |
(1) ICD-10 Condition:F489||Nonpsychotic mental disorder, unspecified. Ayurveda Condition: MANOVAHASROTODUSHTIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Bharamari Pranayam, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
58.00 Year(s) |
| Gender |
Both |
| Details |
PSS (Perceived Stress Scale) score less than 26(out of 40) |
|
| ExclusionCriteria |
| Details |
1) Individuals suffering from any known major illness.
2) Individuals who are doing Pranayam regularly.
3) Individuals taking medication for psychological illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Participants practicing bhramari pranayam may benefit in reducing stress |
Baseline, 7th, 15th & 30th day. and Post up
follow up on 45th day. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Participants practicing bhramari pranayam may benefit in reducing stress level |
Baseline, 7th, 15th & 30th day. & Post up
follow up on 45th day. |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/04/2024 |
| Date of Study Completion (India) |
15/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The World Health Organization (WHO) conceptualizes Mental Health as a “state of wellbeing in which the individual realizes his or her own abilities, can cope with the normal stresses of life, can work productively and fruitfully, and is able to make a contribution to his or her community†(1) Ayurveda has explained Mental stress as a symptom in various classical texts. (2) Ayurveda, has defined Satva as a guna of mana; while Raja and Tama are its doshas. An alpa Satva person is more susceptible to suffer from Mental disorders. (3) There are some causative factors for Manasika Vikaras like Asatmyendriyartha samyoga, Pragyaparadha, and Parinama. (4) An imbalance between Sharirik and Manasik doshas results in Manovaha strotas dushti ultimately leading to Manas rogas. (5) Pranayam is one of the parts of Ashtang Yoga which includes calming down the mind and body as well as enhancing work ability. (6) Bhramari pranayam is the best breathing exercise to relax the mind from anxiety, frustration, anger and hesitation etc. which keeps affecting the performance of our body and mind. (7) By filling the lungs with air forcefully through nostrils, making the noise like male bee and expelling it slowly, making noise like female bee, this practice causes a sort of happiness in the mind of yogindras.(8) Bhramari pranayam is one of the techniques extensively used in society for dealing with stress. (9) Being a police officer is a highly demanding and stressful occupation, due to the current characteristics of modern societies.(10) The present study is an attempt to explore the positive effect of Bhramari pranayam in decreasing mental stress in policemen.
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