Pre-hYpertension tReament With A coMbinatIon of Dietary Supplements and Life-style Modifications
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
- 否
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
Francesco Pelliccia
Assistant Professor
University of Roma La Sapienza
