| CTRI Number |
CTRI/2021/01/030649 [Registered on: 21/01/2021] Trial Registered Prospectively |
| Last Modified On: |
01/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Study of Simple Humming Bee Breathing and breath focused meditation |
|
Scientific Title of Study
|
The impact of humming bee breathing (simple Bhramari Pranayama) practice on Heart Rate Variability and implications for healthcare management |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gunjan Y Trivedi |
| Designation |
PhD Scholar |
| Affiliation |
Dr Jivraj Mehta Smarak Health Foundation |
| Address |
Society for Energy & Emotions, Wellness Space. C119 Swastik Society, Navrangpura, Ahmedabad
Basement office, Bakeri Medical Research Center, Dr Jivraj Mehta Marg, Ahmedabad 380007
Basement office, Bakeri Medical Research Center, Dr Jivraj Mehta Marg, Ahmedabad 380007
Ahmadabad
GUJARAT
380009
India |
| Phone |
|
| Fax |
|
| Email |
gunjan@wellness-space.net |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Banshi Saboo |
| Designation |
Diabetologist |
| Affiliation |
Dia Care Ltd |
| Address |
Dia Care Ltd, Ground Floor, Gandhi Park 1, Nehru Nagar Cross roads, Ambawadi
Ahmadabad
GUJARAT
380015
India |
| Phone |
|
| Fax |
|
| Email |
banshisaboo98@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Banshi Saboo |
| Designation |
Diabetologist |
| Affiliation |
Dia Care Ltd |
| Address |
Dia Care Ltd, Ground Floor Office, Gandhi Park 1, Nehru Nagar Cross roads, Ambawadi
Ahmadabad
GUJARAT
380015
India |
| Phone |
|
| Fax |
|
| Email |
banshisaboo98@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Jivraj Mehta Smarak Health Founction (Infrastructure support) |
|
|
Primary Sponsor
|
| Name |
Dr Jivraj Mehta Smarak Health Foundation |
| Address |
Basement office, Bakeri Medical Research Center, Dr Jivraj Mehta Marg, Ahmedabad 380007
Basement office, Bakeri Medical Research Center, Dr Jivraj Mehta Marg, Ahmedabad 380007 |
| Type of Sponsor |
Other [Infrastructure support] |
|
|
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 |
| Gunjan Y Trivedi |
Dr Jivraj Mehta Smarak Health Foundation |
Basement office, Bakeri Medical Research Centre, Dr Jivraj Mehta Marg, Ahmedabad 380007
Ahmadabad
GUJARAT |
9574742288
gunjan@wellness-space.net |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Jivraj Mehta Smarak Health Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Between Age 18 to 60 |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Breath focused meditation for 20 mins with 1 min break after 10 mins |
Seated in comfortable position, eyes closed with audio instructions guiding the individual to focus on the breath (without regulating the inhalation and exhalation) |
| Intervention |
Simple Bhramari Practice (Humming Bee Breathing) for 20 minutes with 1 min break after 10 mins. The inhalation and exhalation for this practice will be pre-determined and provided to the participant as per a separate study. |
Seated in comfortable position, eyes closed. Audio instructions provided to maintain consistency |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy individuals. Individuals with Type 2 Diabetes and Hypertension. |
|
| ExclusionCriteria |
| Details |
Disease complications and recent surgery (in past 8 weeks) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Measurement of Heart Rate Variability (HRV) throughout the practice |
Measurement of Heart Rate Variability (HRV) for 20 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| SUD (Subjective Unit of Distress) and may include PANAS. |
SUD (Subjective Unit of Distress) measured before the practice of 20 mins. Same for PANAS. |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
25/01/2021 |
| 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="0"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
No data yet, however, intend to publish |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sample size calculations and methodology: There are no studies comparing Bhramari Pranayama with any other practice as per the literature review. With the objective of measuring not only time domain but also frequency domain HRV parameters, the sample size calculation was arrived based on the study of heartfulness and cleaning meditation by (Arya et al., 2018). Based on LF nu reduction from 70.82 ± 14.55 to 55.17 ± 16.63 during the meditation as compared to base line, the sample size turns out to be 32 (i.e. 16+16) based on randomized crossover design. The study will be conducted for the same individuals using randomized crossover design. Audio (recorded) instructions will be provided to ensure consistency for both methods and the participants will be encouraged to take 1 min break after 10 minutes for both the practices.
|