跳至主要内容
临床试验/NCT01682291
NCT01682291Unknown4 期

Pre-hYpertension tReament With A coMbinatIon of Dietary Supplements and Life-style Modifications

University of Roma La Sapienza2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
500
试验地点
2
主要终点
Changes in blood pressure levels as compared with baseline at 1 year

研究概览

简要总结

The primary objective of this study is to compare the efficacy and tolerability of a life-style modifications protocol versus a protocol including life-style modifications along with a novel combination of dietary supplement in the management of subjects diagnosed as having pre-hypertension.

The novel formulation includes: Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250 mg/day)

详细描述

Prehypertension. Prehypertension is an American classification for those subjects with a normal-elevated blood pressure (BP) that does not reach the level considered to be hypertension.

Because of the new data on lifetime risk of hypertension and the impressive increase in the risk of cardiovascular complications associated with levels of BP previously considered to be normal, the JNC 7 report has introduced a new classification that includes the term "prehypertension" for those with BPs ranging from 120-139 mmHg systolic and/or 80-89 mmHg diastolic.

This new designation is intended to identify those individuals in whom early intervention by adoption of healthy lifestyles could reduce BP, decrease the rate of progression of BP to hypertensive levels with age, or prevent hypertension entirely.

Data from the 1999 and 2000 National Health and Nutrition Examination Survey (NHANES III) estimated that the prevalence of prehypertension among adults in the United States was approximately 31%. The prevalence is higher among men than women (39 and 23 percent, respectively).] People with prehypertension are at a higher risk for developing hypertension and target organ damages (i.e. left ventricular hypertrophy), as compared to people with normal blood pressure. Furthermore, similar to hypertension, prehypertension can increase the risk for heart attacks, strokes, congestive heart failure, and renal failure. Researchers have found that a prehypertensive person is 3 times more likely to have a heart attack and 1.7 times more likely to have heart disease than a person with normal blood pressure.

Management of Prehypertension.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

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

入选标准

  • Otherwise healthy subjects with "prehypertension", that is blood pressures ranging from 120-139 mmHg systolic and/or 80-89 mmHg diastolic-

排除标准

  • Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT

结局指标

主要结局

Changes in blood pressure levels as compared with baseline at 1 year

时间窗: 1 year

Changes in systolic and diastolic blood pressure levels as compared with baseline at 1 year

次要结局

  • Reasons for treatment discontinuation(1 year)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francesco Pelliccia

Assistant Professor

University of Roma La Sapienza

研究点 (2)

Loading locations...

相似试验