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

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。在这项研究中，我们希望找到一个人在产生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，我们将研究生姜作为药丸服用后如何在血液中检测到。 在我们的研究中，我们将测试六种不同剂量的生姜。每种剂量有三个人，最高剂量有六个人。生姜的六种剂量分别为100 mg、250 mg、500 mg、1000 mg、1500 mg和2000 mg。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剂量。如果一个人对生姜有轻微的副作用，那么另外三个人将以引起轻微副作用的相同剂量加入研究。此外，如果两个人在相同剂量的生姜下有轻微的副作用，我们将停止研究。引起小副作用的生姜剂量将是安全的最高剂量。 可以参加这项研究的人需要至少18岁，没有疾病，除了避孕药外，不服用任何药物。在开始研究之前，参与研究的每个人都将签署一份知情同意书，其中解释了研究期间将发生的事情。 研究中的每个人都将在服用生姜剂量后在密歇根大学医院停留10小时。在密歇根大学医院停留10小时之前，您必须禁食8小时。一汤匙的血液将采取之前的生姜剂量，然后在15分钟，30分钟，45分钟，一小时，两小时，四小时，六小时，八小时，和十小时后服用生姜剂量。此外，研究中的每个人都将在24、48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.