CTRI Number |
CTRI/2023/11/059417 [Registered on: 02/11/2023] Trial Registered Prospectively |
Last Modified On: |
31/10/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Yoga & Naturopathy |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Bhramari Pranayama on Hypertension patients |
Scientific Title of Study
|
Effect of Bhramari Pranayama on Heart Rate Variability (HRV) in Hypertension - A Randomized controlled 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 |
Dr A Revathy |
Designation |
Post-graduate scholar |
Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu. |
Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
Phone |
9962720401 |
Fax |
|
Email |
dr.revathyarumugam@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr A Gayathri |
Designation |
Head Of Department (Yoga) |
Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
Phone |
8124634017 |
Fax |
|
Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr A Revathy |
Designation |
Post-graduate scholar |
Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu. |
Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu
Kancheepuram TAMIL NADU 603001 India |
Phone |
9962720401 |
Fax |
|
Email |
dr.revathyarumugam@gmail.com |
|
Source of Monetary or Material Support
|
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
|
Primary Sponsor
|
Name |
Dr. A. Revathy |
Address |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu, Tamil Nadu. |
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 A Revathy |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu. |
184/4, International Institute of Yoga and Naturopathy Medical
Sciences, Faculty Block (Ground Floor), Department of Yoga,
Kamarajar Nagar, Chengalpattu. Kancheepuram TAMIL NADU |
9962720401
dr.revathyarumugam@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu Institutional Ethics 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 |
Intervention |
Bhramari Pranayama |
The study participants will receive one day of orientation program before the trial. The study participants will be asked to sit in sukhasana, Keep the eyes closed throughout the practice. Inhale slowly and deeply through the nose, listening to the sound of the breath. Close the ears with the index and middle fingers by pressing the middle outer part of the ear ligament into the ear hole. Keep the ears closed and exhale, making a deep soft humming sound. Concentrate on the sound, keeping it low pitched. When exhalation is complete, lower the hands to the knees and breathe in slowly.(20) Continue to practice in the same way, performing 6 rounds/minute for 3 minutes followed by 30 seconds of normal breathing. When finished, keep the eyes closed and listen for any subtle sounds. Study participants will receive ten minutes of intervention per day for the period of fourteen days along with their regular intake of medication. |
Comparator Agent |
Normal breathing |
The participant will sit in sukhasana in a normal breathing for 10minutes for 14 days |
|
Inclusion Criteria
|
Age From |
30.00 Year(s) |
Age To |
70.00 Year(s) |
Gender |
Both |
Details |
Patients under single drug or two drug combination.
patients who are willing to participate in the study.
Moderate hypertension (systolic 140 - 179mmHg) and (diastolic 90 - 109mmHg) |
|
ExclusionCriteria |
Details |
Patients with secondary hypertention.
Diabetes mellitus, Coronary artery diseases,Heart failure, Arrhythmia, Rheumatic heart disease, Conjenital heart disease and other systemic ( renal , hepatic, pulmonary, nerological and psychatric ) diseases or complications.
Those who are practising yoga regularly for more than one month.
Women during pregnancy and menstruation.
Hypertension patients with blood pressure beyond moderate hypertension. |
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Assessment of Heart Rate Variability (HRV) |
Assessment of Heart Rate Variability (HRV) before and after the intervention in primary hypertension patients. |
|
Secondary Outcome
|
Outcome |
TimePoints |
Assessment of Blood Pressure (BP) |
Assessment of Blood Pressure (BP) before and after the intervention in primary hypertension patients. |
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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 2 |
Date of First Enrollment (India)
|
20/11/2023 |
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="1" Days="1" |
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
|
Hypertension is defined as the increase in blood pressure above the normal level with a systolic and diastolic more than 140/90 mmHg. It is a psychosomatic condition that affects practically everyone, regardless of race or age. Blood arteries in organs including the kidneys, heart, brain, and eyes can become damaged by increased and persistent high blood pressure, which can lead to consequences like stroke, coronary heart disease, renal failure, and blindness. Depending on the causes, hypertension is split into two categories: primary hypertension, which accounts for about 90% of all instances, and secondary hypertension, which accounts for about 10% of all cases. A kind of hypertension called as primary hypertension has an idiopathic or unexplained origin. Non Communicable Diseases (NCDs) are on a rise globally and in India. It is estimated to have caused 9.4 million deaths and 7% of disease burden as measured in disability-adjusted life years in 2010. HTN is the important non communicable disease risk factor in India with an estimated burden of two hundred million persons. Extrapolations suggest that, using current definitions, there are more than 200 million patients with hypertension in the country. Hypertension is labeled as a lifestyle disorder because of the contribution of modifiable risk factors in its development, that is, obesity, unhealthy diet (high intake of saturated fatty acid and salt, low intake of fruits, vegetables, dairy products), physical inactivity, stress, armful use of alcohol, and smoking. Hypertension is prevalent in approximately 25- 26% of world’s population. The World Health Organization (WHO) has identified high blood pressure as one of the most important causes of premature morbidity and mortality in both developed and developing countries. Globally, approximately, 7.6 million deaths occurred per year due to hypertension. According to the World Health Organization (WHO) 2008 estimates, the prevalence of raised Blood Pressure in Indians was 32.5% (33.2% in men and 31.7% in women). Physical inactivity due to usage of electronic gadgets might play a key role in development hypertension. Obesity, hypertension and diabetes mellitus are commonly seen in persons with physical inactivity. Lack of physical activity account for poor control of hypertension and increased risk of cerebrovascular disease and ischemic heart disease in patients with uncontrolled hypertension. Yoga is an alternative therapy for stress management and to reduce blood pressure. Yoga is ancient traditional methods practiced in India for good health and prevention of diseases since last 5000- 8000 years. Yoga consists of various posture (asana), breathing practices and meditation techniques (Pranayama’s) and the most important is yogic behavior. Regular breathing practice reduces sympathetic activity, increases parasympathetic control along with improvement function of respiratory system, cardiovascular system, and neuro-endocrine system. Yogic practices are helpful in autonomic control over visceral functions. Enhanced parasympathetic control and reduced sympathetic activity is seen yogic persons and which ultimately leads to good cardiovascular health. Approximately 4-6 mmHg reduction in systolic blood pressure (SBP) and diastolic blood pressure (DBP) after yoga practices was documented in few studies. Even small reduction in blood pressure after shorter duration of intervention play key role clinically. The reduction in blood pressure which could be the effect of yoga may be useful as an additional therapy in addition to medical treatment of hypertension. Pranayama is a part of yoga, which improves pulmonary function in combination of many pranayama, but the aim of our study is to evaluate the effect of only Bhramari pranayama on heart rate variability in primary hypertension. Yoga is one such tool that can be used in the management of hypertension Pranayama ’is a Sanskrit word that literally means control of vital force (‘Prana’=vital force; ‘Yama’=control). Basically, it consists of three steps: inhalation (purak), retention (kumbhak), and exhalation (rechak).The steps of pranayama can be modified to perform different varieties of slow breathing exercises to improve its effectiveness. Bee-Humming Breathing Exercise (BHB) or ‘Bhramari pranayama’ is one such modification which involves inhalation through both nostrils and while exhalation producing the sound of humming bee as long as possible. Bee-Humming Breathing (BHB) exercise is a simple yogic practice recommended for its favorable effect on cardiac physiology, including blood pressure (BP) and autonomic nervous system. Heart rate variability (HRV) is a commonly used tool to assess the limbs of autonomic nervous system. Heart rate variability is an index of beat-to-beat changes in the heart rate and is a non-invasive assessment of autonomic control of cardiac functions. The series of time intervals between heartbeats, referred to as R-R intervals, are measured over a period of anywhere from 10 min to 24 h. Reduced heart rate variability has been associated with negative consequences to health, particularly related to negative emotions and mental stress. Voluntarily regulated breathing techniques (pranayamas) have been used either alone or in combination with other interventions to reduce stress-related disorders and conditions such as hypertension. These breathing techniques have been practiced most often with the aim of decreasing arousal by correcting the sympatho-vagal imbalance, ie, reducing the sympathetic activity and stimulating vagal efferent activity. |