TRIAL OF AN ENCAPSULATED GINGER STANDARDIZED TO 5%-6-GINGEROLS

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。在这项研究中，我们希望找到一个人在出现副作用之前可以服用的最高剂量的生姜。我们将检查生姜在所有剂量下的安全性。此外，我们还将了解如何在服用生姜药片后在血液中检测到生姜。在我们的研究中，我们将测试六种不同剂量的生姜。每种剂量将有三人，加上最高剂量的六人。六剂生姜分别为100毫克、250毫克、500毫克、1000毫克、1500毫克和2000毫克。如果一个人对生姜有不良副作用，我们将停止研究。低于引起不良副作用的生姜剂量将是安全的最高生姜剂量。如果一个人对生姜有轻微的副作用，就会有另外三个人加入到研究中，剂量与引起轻微副作用的剂量相同。此外，如果两个人在相同剂量的生姜中出现轻微副作用，我们将停止研究。导致小副作用的生姜剂量将是最高剂量的生姜是安全的。能够参加这项研究的人需要至少18岁，没有疾病，除了节育外，不服用药物。在开始研究之前，每个参与研究的人都要签署一份同意书，这份同意书解释了在研究期间会发生什么。研究中的每个人都将在服用生姜后在密歇根大学医院停留10个小时。在密歇根大学医院住院10小时之前，您必须禁食8小时。在服药前、服药后15分钟、30分钟、45分钟、1小时、2小时、4小时、6小时、8小时、10小时采1汤匙血。此外，研究中的每个人都将在24小时、48小时和72小时返回医院抽血。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. In this study, we want to find the highest dose of ginger that a person can take before they have a side-effect. We will check how safe ginger is at all doses. Also, we will look at how ginger can be detected in blood after it is taken as a pill. In our study, we will test six different doses of ginger. There will be three people at each dose, plus six people at the highest dose. The six doses of ginger are 100 mg, 250 mg, 500 mg, 1000 mg, 1500 mg, and 2000 mg. If one person has a bad side-effect to ginger we will stop the study. The ginger dose that is lower than the one that caused the bad side-effect will be the highest dose of ginger that is safe. If one person has a small side-effect to ginger three more people will be added to the study at the same dose that caused the small side-effect. Also, if two people have a small side-effect at the same dose of ginger we will stop the study. The ginger dose that caused the small side-effect will be highest dose of ginger that is safe. People who can be in this study need to be at least 18 years old, have no illnesses and taking no medications, except for birth control. Before starting the study everyone who is in the study will sign a consent form, which explains what will happen during the study. Everyone in the study will stay at the University of Michigan Hospital for 10 hours after taking their ginger dose. You must fast for 8 hours before your 10 hour stay at the University of Michigan Hospital. One tablespoon of blood will be taken before the ginger dose and then at 15 minutes, 30 minutes, forty-five minutes, one hour, two hours, four hours, six hours, eight hours, and ten hours after taking the ginger dose. Also, everyone in the study will return to the hospital at 24, 48 and 72 hour to have their blood drawn.