| CTRI Number |
CTRI/2025/03/081736 [Registered on: 06/03/2025] Trial Registered Prospectively |
| Last Modified On: |
04/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of equi-ratio breathing on heart and lung health in primary hypertension. |
|
Scientific Title of Study
|
IMMEDIATE EFFECT OF SAMA VRITTI PRANAYAMA ON CARDIO-PULMONARY VARIABLES IN PRIMARY HYPERTENSIVE INDIVIDUALS: A RANDOMIZED CONTROL 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 |
DrAbhishek Poojari |
| Designation |
PG Scholar |
| Affiliation |
Shri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Ujire. |
| Address |
Department of yoga therapeutics
Shri Dharmasthala Manjunatheshwara College of Naturopathy and
Yogic Sciences Ujire
Belathangady
Dakshina kannada
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
8105601266 |
| Fax |
|
| Email |
abhishekpoojari15493@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bindu GV |
| Designation |
Assistant proffessor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara college of naturopathy and yogic sciences |
| Address |
Department of Yoga therapeutics
Shri Dharmasthala
Manjunatheshwara
Yoga and Nature Cure
Hospital Dharmasthala.
Dakshina Kannada
KARNATAKA
Shri Dharmasthala Manjunatheshwara college of naturopathy and yogic sciences ujire belathangady dakshina kannada 574240
Dakshina Kannada
KARNATAKA
574216
India |
| Phone |
8277614169 |
| Fax |
|
| Email |
bindu.shridhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bindu GV |
| Designation |
Assistant proffessor |
| Affiliation |
Shri Dharmasthala Manjunatheshwara college of naturopathy and yogic sciences |
| Address |
Department of Yoga therapeutics
Shri Dharmasthala
Manjunatheshwara
Yoga and Nature Cure
Hospital Dharmasthala.
Dakshina Kannada
KARNATAKA
Shri Dharmasthala Manjunatheshwara college of naturopathy and yogic sciences ujire belathangady dakshina kannada 574240
Dakshina Kannada
KARNATAKA
574216
India |
| Phone |
8277614169 |
| Fax |
|
| Email |
bindu.shridhar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of yoga therapeutics
Shri Dharmasthala Manjunatheshwara College of Naturopathy and
Yogic Sciences Ujire
Belathangady
Dakshina Kannada
574240
|
|
|
Primary Sponsor
|
| Name |
Dr Abhishek poojari |
| Address |
Department of yoga therapeutics
Shri Dharmasthala Manjunatheshwara College of Naturopathy and
Yogic Sciences Ujire
Belathangady
Dakshina kannada 574240
Karnataka
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 |
| Dr Abhishek Poojari |
Shri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Ujire. |
Department of yoga therapeutics
Shri Dharmasthala Manjunatheshwara College of Naturopathy and
Yogic Sciences Ujire
Belathangady
Dakshina kannada 574240
India
Dakshina Kannada
KARNATAKA |
8105601266
abhishekpoojari15493@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM Institutional Ethical Committee |
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
|
| Type |
Name |
Details |
| Comparator Agent |
control group |
Sitting normal breathing for 10 minutes
|
| Intervention |
Sama vritti pranayama |
Participants will be informed that they should sit down in a chair or, if they prefer, lie down, and set a timer for 5 minutes.
They will be instructed to inhale then hold their breath for the equivalent duration, then exhale for the same duration, and finally hold their breath again for the same duration.
For example, they will inhale for 4 seconds, hold for 4 seconds, exhale for 4 seconds, and hold again for 4 seconds, repeating this pattern for the entire 5 minutes.
They will be advised that if they feel any strain in maintaining these times, they should reduce the duration of inhales, exhales, and breath holds accordingly.
All breathing will be done through the nose, if possible, but if participants feel the need to switch to breathing through their mouth, they will be allowed to do so. After completing the practice, they will be instructed to return to normal breathing.
Total Duration of intervention 10 minutes |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
35 to 65 years
Both male and female are included
Subjects who are diagnosed as Primary hypertension
Subjects who are under antihypertension medication and non-medication
|
|
| ExclusionCriteria |
| Details |
1 Subjects with other co-morbidities.
2 Subjects diagnosed as Secondary hypertension
3 Subjects with history of Smoking and Alcohol
4 Subjects with increased glycemic profile, history of stroke, current abnormal thyroid function, chronic renal failure, psychological conditions
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Heart rate variability
Pulmonary functions like respiratory rate, forced vital capacity and forced expiratory volume
|
Baseline and immediately after intervention with in 5 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Heart rate
Blood pressure |
Baseline
immediately after intervention with in 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
15/03/2025 |
| 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
|
Hypertension (HTN) is persistent increase in systemic arterial pressure above a predetermined threshold, it is among the leading factors contributing to morbidity and death in developed nations. It is regarded as the main cause of mortality from cardiovascular disease (45%) and cerebrovascular disease (51%). Cardiovascular disorders are the primary cause of death. In South Asia, hypertension is the third most significant risk factor for the attributable burden of disease(2010). Due to resistant or untreated hypertension the risks of heart attack, stroke, and renal failure can be significantly increased . Long-term uncontrolled hypertension also poses a significant risk for macrovascular and microvascular problems such as retinopathy, chronic renal disease, ischemic heart disease, and stroke. Yoga is a science, an art form, and a way of life that promotes wellness. Yoga first emerged in India more than 5000 years ago mainly for spiritual advancement. Practically speaking, yoga practice seeks to overcome human suffering and promote overall health, happiness, and harmony. Pranayama is a part of yoga, this is a formal discipline of breath control. The terms Prana and Yama make up the Sanskrit word pranayama. The term "ayama," which refers to the pranayama activity, meaning "stretch" or "extend.". Pranayama breathing has shown to alter autonomic activity as it increases parasympathetic activity. Vritti pranayama comprises of two types: Samavritti and Visamavritti Pranayama .Samavritti pranayama aims to achieve consistency in the length of each of the four breathing processes: inhalation, retention, exhalation, and retention . It is useful for reducing BP. Sama Vritti Pranayama also called as Box breathing. Breathing patterns and depths directly affect blood pressure, heart rate, ventilation, and oxygenation levels physiologically. There are no studies exploring the influence on autonomic variables. So, the present study was designed to assess the effect of box breathing on cardiopulmonary variables in primary hypertension. |