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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 

 
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