| 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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- 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.
- 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. |