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临床试验/CTRI/2024/04/065869
CTRI/2024/04/065869已完成1 期

Effect of neutral spinal spray on Autonomic variables among hypertensive patients - A single arm intervention study

Dr Smriti Goswami1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2024年4月30日最近更新:

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
132
试验地点
1
主要终点
Heart Rate Variability (HRV)

研究概览

简要总结

The World Health Organization (WHO) defines hypertension as an excessively high or rising blood vessel pressure condition, with a systolic blood pressure reading of 140 mmHg or more, and a diastolic blood pressure value of 90 mmHg or more. Hypertension is one of the major causes of death and disability worldwide.

Several studies have shown that naturopathy, ayurveda, breathing exercises, yoga, meditation, diet therapy, herbal remedies, acupuncture, spiritual therapies, manipulative therapeutics, homoeopathy, and the use of certain essential oils are effective CAM therapies for hypertension (HTN).

Based on the literature authored by Amy Carere, Rob Marc Orr published a paper in the journal Physical Therapy Reviews in September 2016 to determine the impact of hydrotherapy on a patient perceived wellbeing reveals that hydrotherapy can have different impacts on the ANS and CVS depending on the temperature, duration, and mode of water application. There is evidence that thermoneutral water has an antihypertensive impact, which is important for managing and preventing lifestyle disorders including cardiovascular disease (CVD).

In Hydrotherapy, Spinal spraying is a localized hydrating technique that applies a small amount of pressure (1 pressure per square inch, or PSI) and exposes the spinal region to a specified temperature of water for a predetermined amount of time to get the desired results. Since the spinal column is where the majority of nerve roots originate, this process regulates every organ in the body. These include the brain and spinal cord’s sensory, temperature-regulating, vasomotor, sympathetic, and parasympathetic regions. Through improved blood circulation, it enhances the heart’s and lungs’ ability to receive oxygen.

There is a lack of evidence for the mechanism by which hydrotherapy treats various ailments. To understand the mechanism of hydrotherapy and its impact on various conditions more research is required. Therefore, the goal of the study is to assess how promptly neutral spinal spray affects autonomic variables in hypertensive individuals.

Data collection completed.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Pre-diagnosed primary hypertensive subjects
  • Either on or not on regular medication
  • Subjects who are willing to participate after signing the informed consent form.

排除标准

  • Subjects using any psychoactive substances, sedatives, anxiolytics, anti-depressants, and consuming alcohol and nicotine
  • Pyrexia due to any reason
  • Diabetic Neuropathy
  • Mental illnesses
  • Subject with open wound
  • Pregnant Women
  • Female subjects during the menstrual cycle because autonomic variables vary during this period.

结局指标

主要结局

Heart Rate Variability (HRV)

时间窗: Pre and post intervention

次要结局

  • Blood Pressure (SBP, DBP), Pulse Rate, Heart Rate.(Pre & post intervention)

研究者

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

Dr Smriti Goswami

Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Science

研究点 (1)

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