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CTRI Number  CTRI/2025/01/079559 [Registered on: 27/01/2025] Trial Registered Prospectively
Last Modified On: 24/01/2025
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   Ujjayi pranayama on heart rate variability in Hypertension 
Scientific Title of Study   Evaluating the Effect of Ujjayi pranayama on heart rate variability in Hypertension-A Randomised 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 Pavithra S 
Designation  Post-Graduate Scholar 
Affiliation  International institute of yoga and naturopathy medical sciences 
Address  184/4,International Institute of Yoga and Naturopathy Medical Science,Department of yoga,First floor,Kamarajar nagar,Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9789145024  
Fax    
Email  drpavithrasanthanam99@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Gayathri A 
Designation  Head of Department (Yoga) 
Affiliation  International institute of yoga and naturopathy medical sciences 
Address  184/4,International Institute of Yoga and Naturopathy Medical Science,Department of yoga,First floor,Kamarajar nagar,Chengalpattu
chengalpattu
Kancheepuram
TAMIL NADU
603001
India 
Phone  8124634017  
Fax    
Email  gayathriannamalai93@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Pavithra S 
Designation  Post-Graduate Scholar 
Affiliation  International institute of yoga and naturopathy medical sciences 
Address  184/4,International Institute of Yoga and Naturopathy Medical Science,Department of yoga,First floor,Kamarajar nagar,Chengalpattu
chengalpattu
Kancheepuram
TAMIL NADU
603001
India 
Phone  9789145024  
Fax    
Email  drpavithrasanthanam99@gmail.com  
 
Source of Monetary or Material Support  
International Institute of Yoga and Naturopathy Medical Science,Chengalpattu 
 
Primary Sponsor  
Name  Dr Pavithra S 
Address  184/4,International Institute of Yoga and Naturopathy Medical Science,Department of yoga,First floor,Kamarajar nagar,Chengalpattu 
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 Pavithra S  International Institute of Yoga and Naturopathy Medical Sciences,Chengalpattu.  184/4,International Institute of Yoga and Naturopathy Medical Science,Department of yoga,First floor,Kamarajar nagar,Chengalpattu
Kancheepuram
TAMIL NADU 
9789145024

drpavithrasanthanam99@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  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 
Comparator Agent  sitting posture  Control group will be asked to rest in sitting for 10 minutes a day for the period of fourteen days along with regular intake of medication. 
Intervention  Ujjayi pranayama  The study participants will receive one day of orientation 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,take the awareness to the breath.Aftersome time,transfer the awareness to the throat.Feel or imagine that the breath is being drawn in and out through the throat and not through the nostril, as if it is taking place through a small hole in the throat.As the breathing becomes slower and deeper, gently contract the glottis so that a soft snoring sound, like the breathing of a sleeping baby(26).Continue to practice in the same way, performing 8 rounds/minute for 3 minutes followed by 30 seconds of normal breathing. Study participants will receive ten minutes of intervention per day for the period of fourteen days along with their regular intake of medication. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients under a single drug or two drug combination.
Moderate hypertensive (systolic 140–179 mmHg) and (diastolic 90–109 mmHg)
(2017 American Heart Association (AHA)guidelines)
 
 
ExclusionCriteria 
Details  1. Patients with secondary hypertension
2. Diabetes mellitus, coronary artery dis-ease, heart failure, arrhythmia, rheumatic heart
disease, congenital heart disease, and other significant systemic (renal, hepatic,
pulmonary, neurological and psychiatric) diseases or complications.
3. Those who are practicing yoga regularly for more than one or three months.
4. Women during pregnancy and menstruation.
5. Hypertensive patients with Blood Pressure beyond Moderate hypertension (2017
AHA guidelines) 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Heart rate variability  Before and after completing the intervention for a period of 14 days 
 
Secondary Outcome  
Outcome  TimePoints 
blood pressure  Before and after completing the intervention for a period of 14 days 
 
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)   10/02/2025 
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="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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 01-01-2026 and end date provided 31-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Hypertension (HTN) is defined by a systolic blood pressure (SBP) of 130 mm Hg or higher and/or a diastolic blood pressure (DBP) of 80 mm Hg or higher. It is one of the most prevalent chronic conditions and a leading cause of stroke, heart disease, heart failure, and kidney failure. In India, hypertension is responsible for a significant percentage of fatalities. One reason for this is a lack of awareness, as many individuals remain asymptomatic until major health issues arise. Around 90-95% of hypertension cases are primary (essential), caused by environmental, genetic, and lifestyle factors such as poor diet, smoking, alcohol, and sedentary habits. Age-related metabolic disorders like insulin resistance also contribute to higher blood pressure, which increases the risk of various cardiovascular and kidney diseases. Management of hypertension involves lifestyle changes like diet and exercise. If ineffective, medication such as diuretics, beta-blockers, calcium channel blockers, ACE inhibitors, and ARBs may be prescribed to achieve a target blood pressure of 130/80 mm Hg or lower. Yoga, especially pranayama (breathing exercises), has been found to have a significant antihypertensive effect. Pranayama involves controlled breathing techniques like inhalation, retention, and exhalation to regulate heart rate and blood pressure. It reduces heart rate and both systolic and diastolic blood pressure, benefiting the cardiovascular system. Ujjayi pranayama, known as "victorious breath," is particularly beneficial for reducing stress and improving cardiovascular function. This technique helps restore autonomic balance by reducing sympathetic nervous activity and enhancing parasympathetic response, which improves heart rate and overall heart health. Heart rate variability (HRV) is a useful tool to assess autonomic nervous system function, and studies show that pranayama can increase HRV, improving the balance between the sympathetic and parasympathetic systems. This balance is essential for managing stress and hypertension effectively. Overall, yoga and pranayama provide a complementary approach to hypertension management by promoting relaxation, improving autonomic function, and reducing stress. These practices offer an additional, natural option for those seeking non-pharmacological ways to manage their blood pressure.

 
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