| CTRI Number |
CTRI/2023/04/051650 [Registered on: 17/04/2023] Trial Registered Prospectively |
| Last Modified On: |
25/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to see the effect of Bhramari Pranayam(Yogic Breathing Technique)in the management of stress in working women. |
|
Scientific Title of Study
|
A Single arm clinical study to evaluate the efficacy of Bhramari Pranayam in the management of stress in working women. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NIDHI KHINDRI |
| Designation |
MD SCHOLAR SWASTHAVRITTA |
| Affiliation |
Dr.D.Y.PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE |
| Address |
O.P.D.NO.7,ground floor, Swasthavritta department,
Dr.D.Y.Patil college of ayurved&research centre,
Sant Tukaram nagar,Pimpri
Pune-411018
Maharashtra
India
Dr.D.Y.Patil vidyapeeth,Pune
Dr.D.Y.Patil college of ayurved &research centre,
Sant Tukaram nagar,Pimpri
Pune-411018
Maharashtra
India
Pune
MAHARASHTRA
411018
India |
| Phone |
8146513030 |
| Fax |
|
| Email |
nidhikhindri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrJYOTSNA YADAV |
| Designation |
ASSOCIATE PROFESSOR SWASTHAVRITTA |
| Affiliation |
Dr.D.Y.PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE |
| Address |
O.P.D.NO.7,ground floor, Swasthavritta department,
Dr.D.Y.Patil college of ayurved&research centre,
Sant Tukaram nagar,Pimpri
Pune-411018
Maharashtra
India
Dr.D.Y.Patil vidyapeeth,Pune
Dr.D.Y.Patil college of ayurved &research centre,
Sant Tukaram nagar,Pimpri
Pune-411018
Maharashtra
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9518748341 |
| Fax |
|
| Email |
drjyotsnahande1988@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrJYOTSNA YADAV |
| Designation |
ASSOCIATE PROFESSOR SWASTHAVRITTA |
| Affiliation |
Dr.D.Y.PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE |
| Address |
O.P.D.NO.7,groundfloor,
Swasthavritta department,
Dr.D.Y.Patil college of ayurved&research centre,
Sant Tukaram nagar,Pimpri
Pune-411018
Maharashtra
India
Dr.D.Y.Patil vidyapeeth,Pune
Dr.D.Y.Patil college of ayurved &research centre,
Sant Tukaram nagar,Pimpri
Pune-411018
Maharashtra
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9518748341 |
| Fax |
|
| Email |
drjyotsnahande1988@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.D.Y.PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE SANT TUKARAM NAGAR PIMPRI PUNE 411018 MAHARASHTRA INDIA |
|
|
Primary Sponsor
|
| Name |
Nidhi khindri |
| Address |
O.P.D.NO.7,ground floor, Swasthavritta department,
Dr.D.Y.Patil college of ayurved&research centre,
Sant Tukaram nagar,Pimpri
Pune-411018
Maharashtra
India |
| 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 |
| NIDHI KHINDRI |
DR.D.Y.PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE PIMPRI PUNE |
OPD NO.7 SWASTHAVRITTA DEPARTMENT GROUND FLOOR
Dr.D.Y.PATIL COLLEGE OF AYURVED AND RESEARCH CENTRE
SANT TUKARAM NAGAR
PIMPRI
PUNE-411018
MAHARASHTRA
INDIA
Pune
MAHARASHTRA |
8146513030
nidhikhindri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
STRESS |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Procedure | - | Bhramari Pranayam(yogic breathing technique) | (Procedure Reference: Hath yog pradipika/chapter 2/verse68, Procedure details: 20 rounds of Bhramari Pranayam (yogic breathing technique)per day for 20 consecutive days would be practised.
STANDARD OPERATING PROCEDURE
1. Sit in Sukhasana (easy sitting pose)position with an erect spine and stable mind.Keep the
eyes closed throughout the practice.
2. The practice of Puraka(Inhalation)Rechaka(Exhalation) for ten rounds.
3. Practice ‘Shanmukhi mudra’ i.e Close the ears with the thumb, index
finger on the forehead,middle fingers on eyes,ring fingers on nostrils
and l)
|
|
|
|
Inclusion Criteria
|
| Age From |
22.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.WOMEN WORKING FOR MINIMUM 8 HOURS IN CONTINUATION PER DAY.
2.SUBJECTS WITH SCORE 27-40 ON PERCEIVED STRESS SCALE. |
|
| ExclusionCriteria |
| Details |
1.KNOWN CASES OF SEVERE PSYCHOLOGICAL DISORDERS.
2.KNOWN CASES OF SEVERE SYSTEMIC DISORDERS.
3.PATIENTS CONTRA-INDICATED FOR BHRAMARI PRANAYAM SUCH AS KNOWN CASES OF SEVERE CARDIO VASCULAR DISEASES,EAR INFECTION ETC. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bhramari pranyaam is effective in the management of stress. |
Outcome will be assessed after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Measurement of the levels of stress and stress score in working women with the help of Perceived Stress Scale. |
Outcome will be assessed after 3 weeks |
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
Final Enrollment numbers achieved (Total)= "69"
Final Enrollment numbers achieved (India)="69" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/06/2023 |
| Date of Study Completion (India) |
15/05/2024 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
According to yogic texts Bhramari Pranayam relieves stress and cerebral tension, increasing the healing capacity of the body. It induces a meditative state by harmonizing the mind and directing the awareness inwards.The vibration of the humming sound creates a soothing effect on the mind and nervous system. Study of previous literature showed there is dearth of work done on the effects of Bhramari Pranayam. Additionally,according to previous research,women are vulnerable to stress.And women working at workplaces for hours at a stretch are more prone to havig stress.Therefore this study aims to evaluate the effect of Bhramari Pranayam in the management of stress in working women.
Its a single arm clinical study where intervention of 20 rounds of Bhramari Pranayam would be given for 20 consecutive days to the subjects after a screening pre test based on the quessionnaire of Percieved stress scale. Follwed which,a post test would be conducted based on the same quessionnaire to see the effect of Bhramari Pranayam on the stress levels. |