Effect of Hibiscus Sabdariffa on Blood Pressure in a University Population
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 40
- 主要终点
- Blood Pressure (BP)
研究概览
简要总结
Hypertension, also known as high blood pressure, is a very common disease and is considered "the silent killer". Hypertension is responsible for at least 45% of deaths due to heart disease, and 51% of deaths due to stroke. Hypertension plays a part in the worry of heart disease, stroke and kidney failure and premature mortality and disability. If hypertension goes uncontrolled, in the long term, it will cause serious complications, most of which will necessitate costly interventions to be solved and managed. Apparently, these interventions may include cardiac bypass surgery, carotid artery surgery and dialysis, draining individual and government budgets. Recent studies show that hibiscus (Hibiscus sabdariffa) tea can lower blood pressure as effectively as some standard anti-hypertensive drugs can. Hibiscus is widely consumed around the world as a ruby-colored, lemony beverage. Hibiscus is safe and, unlike most blood pressure drugs, rarely causes side effects. All of the studies the investigators found in the literature were either underpowered or inconclusive. All of these studies recommended further studies with bigger samples to accurately assess the effect of hibiscus sabdariffa on blood pressure in hypertensive patients. The aim of this study is to assess the feasibility of a large-scale study assessing the effectiveness of Hibiscus sabdariffa on lowering blood pressure in individuals with elevated blood pressure.
详细描述
Research Question:
Will daily consumption of 240 ml of Hibiscus sabdariffa reduce blood pressure in individuals with elevated blood pressure?
Research Objectives:
Primary: To conduct a feasibility study investigating the effect of daily consumption of 240 ml of Hibiscus sabdariffa on blood pressure in individuals with elevated blood pressure
Secondary: To investigate the effect of daily consumption of 240 ml of Hibiscus sabdariffa on low-density lipoprotein (LDL) levels
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both sexes
- •Age 18 - 70 years
- •Abnormal blood pressure (SBP 120 - 139 mm Hg; DBP 80 - 89 mm Hg)
- •Sulaiman Al Rajhi Colleges affiliate (student, teaching staff member, administrative staff member, worker)
- •No regular medication
排除标准
- •Allergic to hibiscus sabdariffa
- •Normal blood pressure (SBP ≤ 120 mm Hg; DBP ≤ 80 mm Hg)
- •Essential hypertension Stage II or higher (SBP ≥ 140 mm Hg; DBP ≥ 90 mm Hg)
- •Hypertension due to secondary causes
- •Other comorbid conditions (diabetes mellitus, renal failure, coronary artery disease, heart failure, malignant hypertension [BP ≥ 180/110], etc.)
- •Regular hibiscus user
- •Pregnancy
- •Any metabolic or malabsorptive disease that may interfere with absorption of hibiscus sabdariffa (e.g. coeliac disease, chronic pancreatitis, etc.)
- •Diagnosis of a sleep disorder or use of medication that interferes with sleep (either causing drowsiness or wakefulness)
- •Diagnosis of a mood disorder or stress disorder
- •Taking psychiatric medication (mood stabilizers, antidepressants, anxiolytics, or antipsychotics)
研究组 & 干预措施
Intervention Arm (or Group)
This arm will receive the intervention (Hibiscus Sabdariffa extract supplement)
干预措施: Hibiscus Sabdariffa (Dietary Supplement)
Control Arm (or Group)
This arm will receive no intervention whatsoever, not even placebo
结局指标
主要结局
Blood Pressure (BP)
时间窗: 3 months
The investigators want to see the effect of Hibiscus Sabdariffa on the blood pressure of participants in the intervention group.
次要结局
- Low-density lipoprotein (LDL) levels(3 months)
- The Pittsburgh Sleep Quality Index (PSQI)(3 months)
- The Depression, Anxiety, and Stress Scales (DASS)(3 months)
- The Perceived Stress Scale (PSS)(3 months)