Prospective Safety and Tolerability Assessment of a Cardiovascular Health Dietary Supplement
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety and tolerability of a cardiovascular health dietary supplement assessed by composite changes in multi-system symptoms, a validated mood/depression questionnaire, electrolytes, and surrogate markers of heart, liver and kidney function
研究概览
简要总结
This single-arm, open-label study will assess the safety and tolerability of one daily tablet of a commercially available cardiovascular health dietary supplement by questionnaire and blood markers in adults with borderline to mild hypertension over a 6 month period. Although the cardiovascular health dietary supplement being investigated has been on the market for over 20 years, prospective safety data and blood markers of end organ function have not previously been reported.
详细描述
Hypertension is an important overall risk factor for developing cardiovascular disease in the United States, and is a leading risk factor for cardiovascular events, including myocardial infarction and stroke, and cardiovascular-related mortality with advancing age. Based on population based studies and clinical trials, both systolic blood pressure (SBP) and diastolic blood pressure (DBP) elevations are continuous, strong and independent risk factors for cardiovascular disease.
The product being studies is a cardiovascular health dietary supplement that has been commercially available since 1993. It is currently sold to healthcare practitioners as well as directly to consumers. Some healthcare providers use the product as part of a plan to treat high blood pressure in their patients. This is the first study collecting prospective safety data on this product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65
- •Systolic blood pressure 120-159 mmHg or diastolic blood pressure 80-99 mmHg upon screening
排除标准
- •Bradycardia
- •Initiation of or changes to blood pressure lowering medications within the last month
- •Initiation of or changes to thyroid medications within the last month
- •Currently taking any of the following orally (or they were taken within the last month):
- •Rauwolfia serpentina, Terminalia arjuna, Tribulus terrestris, Convolvulus pluricaulis, Boerhavia diffusa, Rosa vinca, rose powder, or coral powder
- •Beta blockers
- •Alpha blockers
- •Propranolol
- •Anti-depressant medications
- •Anti-psychotic medications
- •Sedatives or tranquilizers
- •Present or past history of any of the following:
- •Cardiovascular disease
- •Heart surgery
- •Cardiac arrhythmia
- •Abnormal EKG
- •Abnormal echocardiogram
- •Chronic liver, kidney or bowel disease
- •Gallbladder disease
- •Depression
- •Alcoholism
- •Obstructive sleep apnea and/or use of a continuous positive airway pressure device
- •Parkinson's disease
- •Pheochromocytoma
- •Cancer within the last 5 years
- •Consuming more than fourteen alcoholic beverages per week
- •Current smoking/tobacco use
- •Current illicit and/or recreational drug use
- •Women who are lactating, pregnant or planning pregnancy within the next six months
- •Known intolerance or allergy to study agents
研究组 & 干预措施
Cardiovascular Health Dietary Supplement
The cardiovascular health dietary supplement will be administered at a dosage of 1 caplet po per day for a period of 6 months
干预措施: Cardiovascular health dietary supplement (Dietary Supplement)
结局指标
主要结局
Safety and tolerability of a cardiovascular health dietary supplement assessed by composite changes in multi-system symptoms, a validated mood/depression questionnaire, electrolytes, and surrogate markers of heart, liver and kidney function
时间窗: Baseline, 3 months, 6 months
Standardized adverse event monitoring form, Patient Health Questionnaire (PHQ-9), electrolytes (sodium, potassium, calcium, magnesium), b-type natriuretic peptide, aspartate aminotransferase, alanine aminotransferase, and estimated glomerular filtration rate
次要结局
未报告次要终点
研究者
Jennifer Ryan
Postdoctoral Fellow
National University of Natural Medicine