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临床试验/CTRI/2025/01/079523
CTRI/2025/01/079523尚未招募2 期

Effect of Hridaya Mudra on Heart Rate Variability in Patients with Primary systemic Hypertension - A Randomized Controlled Trial

Dr A Mrinalinee1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年2月10日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Assessment of Heart Rate Variability (HRV)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
30.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Assessment of Heart Rate Variability (HRV)

时间窗: Baseline, 2 weeks

次要结局

  • Assessment of Systolic Blood Pressure (SBP) & Diastolic Blood Pressure (DBP)(Baseline, 2 weeks)

研究者

发起方
Dr A Mrinalinee
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Mrinalinee A

International Institute Of Yoga And Naturopathy Medical Sciences, Chengalpattu

研究点 (1)

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