| CTRI Number |
CTRI/2025/04/086026 [Registered on: 30/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Brahmari Pranayama in stress reduction |
|
Scientific Title of Study
|
The immediate effect of Brahmari Pranayama in indoor and outdoor practice in stress reduction among hypertensive individuals- A comparative randomised trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Natasha Thoidingjam |
| Designation |
PG scholar |
| Affiliation |
SDM College of Naturopathy and yogic science |
| Address |
Department of naturopathy,SDM College of Naturopathy and yogic science,Ujire
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
7630882120 |
| Fax |
|
| Email |
natashathoidingjam2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ABITONE V R |
| Designation |
HOD,Department of anatomy |
| Affiliation |
SDM College of Naturopathy and yogic science |
| Address |
HOD,Department of anatomy,SDM College of Naturopathy and yogic science,Ujire
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9655976897 |
| Fax |
|
| Email |
dr.abitone@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ABITONE V R |
| Designation |
HOD,Department of anatomy |
| Affiliation |
SDM College of Naturopathy and yogic science |
| Address |
HOD,Department of anatomy,SDM College of Naturopathy and yogic science,Ujire
Dakshina Kannada
Karnataka
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9655976897 |
| Fax |
|
| Email |
dr.abitone@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara college of Naturopathy and yogic sciences |
|
|
Primary Sponsor
|
| Name |
Natasha Thoidingjam |
| Address |
PG SCHOLAR,Department of naturopathy,SDM College of Naturopathy and yogic science,Ujire
Dakshina Kannada
Karnataka |
| 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 |
| DrNatasha Thoidingjam |
Sri Dharmasthala Manjunatheshwara yoga and nature cure hospital |
Shantivana nature cure hospital,
Dharmasthala
Dakshina Kannada
KARNATAKA |
7630882120
natashathoidingjam2@gmail.co |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm (Non Ayurveda) | | - | INDOOR BHRAMARI PRANAYAMA | Bhramari Pranayama (Bhr.P) training was conducted by certified yoga instructors following established guidelines. Participants were seated comfortably with their spines straight & eyes closed. They were instructed to inhale deeply & slowly through both nostrils for approximately 5 seconds, then exhale slowly & deeply for about 15 seconds while placing their thumbs over their external auditory canals. During the exhalation phase, they were also asked to producing a humming nasal sound similar to a wasp, which generates mild vibrations in the laryngeal walls & the inner nostrils. Each cycle of Bhr.P involved this breathing technique performed at a rate of 3-4 breaths per minute, followed by a one-minute rest. Participants were permitted to practice up to 5 cycles, total 10minutes, in this manner. This practice has been conducted at the SDMYNCH Yoga Hall, a space designed to provide an optimal environment for yoga. The hall is well-ventilated, featuring large windows that allow ample natural light to flood the room, creating a warm & inviting atmosphere. The air quality is maintained at a high standard, ensuring a fresh & invigorating environment. The interior is elegantly decorated with calming colors & soft, ambient lighting, which helps to foster a sense of peace & relaxation. Additionally, the hall is equipped with comfortable mats & supportive seating to enhance comfort during practice. Overall, the setting is thoughtfully designed to support both physical & mental well-being, contributing to a deeply immersive & rejuvenating yoga experience | | 2 | Comparator Arm (Non Ayurveda) | | - | OUTDOOR BHRAMARI PRANAYAMA | Bhramari Pranayama (Bhr.P) training was conducted by certified yoga instructors following established guidelines. Participants were seated comfortably with their spines straight & eyes closed. They were instructed to inhale deeply & slowly through both nostrils for approximately 5 seconds, then exhale slowly & deeply for about 15 seconds while placing their thumbs over their external auditory canals. During the exhalation phase, they were also asked to producing a humming nasal sound similar to a wasp, which generates mild vibrations in the laryngeal walls & the inner nostrils. Each cycle of Bhr.P involved this breathing technique performed at a rate of 3-4 breaths per minute, followed by a one-minute rest. Participants were permitted to practice up to 5 cycles, total 10minutes, in this manner. Outdoor pranayama practice is conducted in a natural & open setting, which offers a refreshing & stimulating atmosphere for participants. The clean, fresh air enhances breathing quality, while the natural light & soothing sounds of nature, like birds chirping or leaves rustling, contribute to a tranquil & calming environment. The spaciousness of the outdoors allows for unobstructed breathing & a sense of freedom, while the natural surroundings help to reduce stress & enhance the overall sense of well-being. This environment supports a harmonious connection between breath, body, & nature. "Practicing in favorable weather conditions, such as mild or slightly cool temperatures, helps regulate body temperature & ensures a more comfortable & pleasant expirence . |
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
*Primary hypertension patients
*Both male and female
*Age from 30 to 60 years who visited the hospital hospital included |
|
| ExclusionCriteria |
| Details |
*Pregnant women
*Person suffering from severe mental illness
*Individual with active respiratory infections,Chronic renal disease
*Hypertensive patient with cognitive instability
*Recently ubderwent cardiac and pulmonary rehab program |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood pressure, Breath holding time, spO2, Respiratory Rate |
30 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
04/05/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
A total of 60 subjects were assigned to two groups based on inclusion and exclusion criteria. Group 1 was participated in indoor practice of Brahmari pranayama, while Group 2 had been engage in outdoor practice of Brahmari pranayama. This practice had been conducted for 10 minutes.
Baseline and post-intervention assessment data were collected before the practice and immediately after the practice and one hour after the intervention. |