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临床试验/NCT03512106
NCT03512106Unknown不适用

The Efficacy of the Acupuncture in the Treatment of Systemic Arterial Hypertension

silvia goldmeier0 个研究点目标入组 86 人开始时间: 2018年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
86
主要终点
Ambulatory Blood Pressure Monitoring

研究概览

简要总结

There are few studies in the treatment of hypertension employing acupuncture as a blood pressure regulating technique. The Ministry of Health synthesized the inclusion of integrative and complementary practices within the Unique Health System, such as acupuncture. Our objective is to verify the effect of the acupuncture session on hypertensive patients, measured through ambulatory blood pressure monitoring (ABPM). In this way two groups of patients will be selected in a randomized clinical trial. In the first group, Chinese traditional acupuncture will be applied and in the second group the acupuncture sham will be applied.

详细描述

Acupuncture as therapy is the subject of conflicting opinions on its effectiveness in scientific means, because in spite of its long existence as a therapeutic tool, raises doubts on the standards of Western science model. In addition, there are few studies in the treatment of hypertension employing Acupuncture as a blood pressure regulating technique. The Ministry of Health synthesized the inclusion of integrative and complementary practices within the Unique Health System, such as Acupuncture. The World Health Organization (WHO) recognizes its effectiveness, having its own concept in the energy imbalance that alter the organic, mental and emotional part addressing a current issue proposing to groundbreaking research. The objective is to verify the effect of the acupuncture session on hypertensive patients, measured through ambulatory blood pressure monitoring (ABPM). In this way two groups of patients will be selected in a randomized clinical trial. In the first group, Chinese traditional acupuncture will be applied and in the second group the acupuncture sham will be applied.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Acupuncture sham will be applied (placebo).

入排标准

年龄范围
45 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients enrolled in stage I to III of systemic arterial hypertension
  • signing the free and informed consent term

排除标准

  • patients who do not agree to participate in the study
  • patients with systolic pressure values greater than 180 mmHg or diastolic pressure above 110 mmHg
  • patients with important comorbidities

研究组 & 干预措施

Sham group

Placebo Comparator

Sham

干预措施: Acupuncture (Other)

Acupuncture group

Experimental

Chinese traditional acupuncture

干预措施: Acupuncture (Other)

结局指标

主要结局

Ambulatory Blood Pressure Monitoring

时间窗: 24 hours

Ambulatory blood pressure monitoring (ABPM) is a feature that enables direct and indirect direct reference to blood pressure in the period 24 or more successive hours with a low level of discomfort throughout the daily activities of the investigated. The possibility of obtaining a representative curve of pressure variations in a given period gives an efficient view of the tension behavior and not simply a static analysis, reflecting only the moment when blood pressure was measured.

次要结局

未报告次要终点

研究者

发起方
silvia goldmeier
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

silvia goldmeier

PhD

Instituto de Cardiologia do Rio Grande do Sul

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