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CTRI Number  CTRI/2025/01/079523 [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   Hridaya mudra for Hypertension 
Scientific Title of Study   Effect of Hridaya Mudra on Heart Rate Variability in Patients with Primary systemic 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 Mrinalinee A  
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, Department Of Yoga, Kamarajar Nagar, Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  9962404440  
Fax    
Email  mrinalineearun@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, 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 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, Department Of Yoga, Kamarajar Nagar, Chengalpattu

Kancheepuram
TAMIL NADU
603001
India 
Phone  8124634017  
Fax    
Email  gayathriannamalai93@gmail.com  
 
Source of Monetary or Material Support  
184/4,International Institute Of Yoga And Naturopathy Medical Sciences, Faculty Block, Department of Yoga, Kamarajar Nagar, Chengalpattu - 603001, Tamilnadu, India. 
 
Primary Sponsor  
Name  Dr A Mrinalinee 
Address  184/4, International Institute Of Yoga And Naturopathy Medical Sciences, Faculty Block, Department Of Yoga, Kamarajar Nagar, Chengalpattu - 603001, Tamilnadu, India. 
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 Mrinalinee A  International Institute Of Yoga And Naturopathy Medical Sciences  184/4, International Institute Of Yoga And Naturopathy Medical Sciences, Faculty Block (First Floor), Department Of Yoga, Kamarajar Nagar, Chengalpattu - 603001.
Kancheepuram
TAMIL NADU 
9962404440

mrinalineearun@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  Hridaya Mudra  The study participants will receive one day of orientation program before the trial. The study participants will be asked to practice Hridaya Mudra in Shavasana for 15 minutes each day for a period of 6 days per week for 2 weeks. 
Comparator Agent  Rest in supine position  The study participants will be asked to rest in the supine position for 15 minutes each day for a period of 6 days per week for 2 weeks. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Systolic blood pressure between 140-180mmHg and diastolic blood pressure between
90-110mmHg.
Patients under single drug or two drug combination.
Patients who are willing to participate in the study.  
 
ExclusionCriteria 
Details  Patients with secondary hypertension.
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.
Those who were practicing yoga regularly for more than one month.
Subjects unable to perform Hridaya mudra.  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Assessment of Heart Rate Variability (HRV)  Baseline, 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of Systolic Blood Pressure (SBP) & Diastolic Blood Pressure (DBP)  Baseline, 2 weeks 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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 is a condition characterized by consistently elevated pressure within the blood vessels. This pressure results from the blood moving through the arteries and exerting force against their walls. Systolic blood pressure measuring more than 140mmHg, diastolic blood pressure measuring more than 90mmHg on two different days is considered as hypertension. There are two types of hypertension which includes primary or essential type having no known etiology and secondary type arising due to various causes. Hypertension manifests through very complex pathophysiological mechanisms. In accordance with Page Mosaic theory genetic, anatomical, neural, humoral, hemodynamic, endocrinal and environmental factors and their interactions play key role in causing primary hypertension. This theory, explains high blood pressure is caused by a combined role of sympathetic nervous system overactivity, impairment of the vascular relaxation, immune reactivity malfunctioning and impairment in the pressure natriuresis relationship induced by inflammation. Family history mostly credited to be the cause of primary hypertension in which genetics plays an important role and combined with lifestyle factors such as high sodium and/or alcohol intake, increased mental stress and deficient sleep quality pave way to the incidence of hypertension. With increasing age hypertension may develops due to changes occur in the vascular collagen that slowly progresses to stiffening of the arteries and atherosclerosis formation.

World Health Organization claims that an estimated 1.28 billion adults worldwide in the age group of 30–79 years have hypertension, and two-thirds of them live in low- and middle income countries. While 46% of adults with hypertension are unaware of their condition, 42% are diagnosed and treated and only 21% have it under control. The prevalence in India is estimated to be 220 million with only 12% of this population having their blood pressure under control. Non-optimal blood pressure contributes to be a crucial risk factor for the global burden of disease and all-cause mortality. Almost 63% of total deaths in India can be attributed to noncommunicable diseases and 27% of this is due cardiovascular disease. Raised blood pressure is a major and most commonly preventable risk factor for CVDs like coronary heart disease, myocardial infarction, peripheral artery disease, heart failure, stroke, atrial fibrillation, peripheral artery disease and also cognitive impairment and chronic kidney disease. Preventing and effectively treating hypertension is vital for reducing disease burden and enhancing longevity in the global population. Controlling hypertension reduces the risks of cerebrovascular accident by 35-40%, heart failure by 50%, and myocardial infarction by 20 25%.

The conventional management for hypertension includes antihypertensive drug classes like beta-blockers, angiotensin converting enzyme inhibitors, diuretics, angiotensin II receptor antagonists, calcium channel blockers, alpha-adrenergic receptor blockers, renin inhibitors, centrally acting agents, and direct acting vasodilators. However there exists a reluctance among patients to adhere to these drugs due to its interactions, side effects as well as high cost which may lead to uncontrolled hypertension. Another reason for unsuccessful management of hypertension is poor stress management. Stress also leads to poor lifestyle choices like unhealthy diet, avoidance of physical activity, tobacco use and harmful alcohol use. Stress is subjective nature and there is no standard pharmacotherapy for its management. However, yoga is known to reduce stress and induce relaxation. Clinical studies have exhibited that yoga has a positive influence on both physical and mental risk factors for hypertension.

Yoga is a way of life and rooted in ancient system of health. It is a practice focusing on body, mind and spirit. Though its origin is based on philosophy and spirituality, it is also used for wellness and therapeutic purposes in recent times. The physical aspects of yoga include shatkriya, asana, pranayama, mudra, and bandhas. A mudra is a symbolic representation involving the whole body. While practicing Hasta (hand) mudras, the subtle hand and finger movements stimulate specific energy pathways by making important connections in the nervous system. Hridaya Mudra (or) Apana vayu Mudra is beneficial for heart-related diseases. This gesture includes the use of thumb, index finger, middle finger and ring finger. The heart gesture (Hridaya Mudra) maintains heart health by stimulating a nadi that flows to the heart and thereby redirecting energy to the heart. Studies analyzing the effect of Hridaya Mudra show significant reduction in systolic blood pressure, diastolic blood pressure and heart rate indicating a shift in the balance of the autonomic nervous system towards the parasympathetic nervous system. The activity of the autonomic nervous system can be assessed non-invasively by Heart Rate Variability (HRV). It used to establish the relationship between imbalances in autonomic nervous system activity as a causative factor and cardiovascular diseases.

To date, no randomized controlled trial has been conducted to specifically examine the effects of Hridaya mudra on heart rate variability in patients with primary systemic hypertension.  
 
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