The Hemodynamic and Electrocardiographic Effects of Hoodia Gordonii in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Evaluate the electrocardiographic effect, primarily the effect on the PR and RR intervals of H. gordonii in healthy individuals.
研究概览
简要总结
The purpose of the study is to learn about an herbal product called Hoodia gordonii. We want to know if Hoodia gordonii affects blood pressure, heart rate (pulse), heart pressures, and the heart's electrical conduction system. To participate in this study you must be a healthy volunteer with no known medical problems.
详细描述
If you decide to join this research study you will come in for two visits one week apart. Each visit will last 8 hours (you will not be required to stay in the exam room for the entire day). During the first visit you will be assigned, by chance, like the flip of a coin, to get either Hoodia gordonii or placebo. A placebo is a pill that looks like the herbal supplement but does not have any active ingredients in it. During the second visit you will get either Hoodia or placebo, whichever you did not get during the first visit. Neither you nor your study doctor will know ahead of time if you will get Hoodia or placebo during the first visit.
If you choose to participate in this study you have the following tests performed.
A. Electrocardiogram (ECG): this is a test that measures the electrical activity in the heart. This test involves placing 10 stickers on the chest and stomach and will last about 1 minute.
B. Blood Pressure: this is a test that involves placing a cuff on your arm and inflating it. Blood pressure cuffs might make you feel uncomfortable when they inflate, but it is not painful. The cuff will be placed on your arm for approximately 3 minutes.
C. Hemodynamics: these are tests that measure the pressures in the heart. This test involves placing 4 stickers (2 on your neck and 2 on your stomach) and is done while lying down. This test will last about 3 minutes and will be done at the same time as the blood pressure test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects at least 18 years of age and in general good health expressing interest in participating in the study will be evaluated for inclusion.
排除标准
- •baseline heart rate less than 50 beats/minute or greater than 100 beats/minute
- •heart rhythm other than normal sinus
- •history of atrial or ventricular arrhythmia
- •family history of premature sudden cardiac death
- •left ventricular hypertrophy
- •atherosclerosis
- •hypertension
- •palpitations
- •T-wave abnormality
- •baseline corrected QT(QTc) interval greater than 440 milliseconds (ms)
- •thyroid disease
- •type 1 or 2 diabetes mellitus
- •recurrent headaches
- •depression
- •any psychiatric condition or neurological disorder
- •history of alcohol or drug abuse
- •renal or hepatic dysfunction
- •concurrent use of potentially interacting drugs (anticoagulants, MAO inhibitors, CYP 3A impacted drugs (substrate, inducer, or inhibitor) over the counter medications containing pseudoephedrine, caffeine containing products, or any dietary supplements)
- •subject unwillingness to sign informed consent
- •Pregnant or lactating females will also be also excluded from participation with urine dipstick tests used to confirm lack of pregnancy.
结局指标
主要结局
Evaluate the electrocardiographic effect, primarily the effect on the PR and RR intervals of H. gordonii in healthy individuals.
时间窗: Baseline, 1, 3, 5 and 8 hours after taking study drug
次要结局
- Evaluate other electrocardiographic effects, specifically effects on the QTc, QRS, and Tpe intervals of H. gordonii in healthy individuals.(Baseline, 1, 3, 5, and 8 hours after taking study drug)
- Evaluate the impact of H. gordonii on the following hemodynamic parameters: Blood Pressure, Cardiac Output, Systemic Vascular Resistance, and Thoracic Fluid Content.(Baseline, 1, 3, 5, and 8 hours after taking study drug.)