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

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• 批准号: 7376588
• 负责人: SUZANNA M. ZICK
• 金额: $ 7.26万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-05 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376588
• 关键词: blood; family planning; fasting; hospitals; university

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.

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。在这项研究中，我们想要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。我们会检查各种剂量的生姜的安全性。此外，我们将研究生姜作为药丸服用后如何在血液中检测出来。在我们的研究中，我们将测试六种不同剂量的生姜。每个剂量有三个人，加上最高剂量的六个人。生姜的六种剂量分别是100毫克、250毫克、500毫克、1000毫克、1500毫克和2000毫克。如果一个人对姜有不良副作用，我们将停止研究。生姜的剂量低于产生不良副作用的剂量，即是安全的最高剂量。如果一个人对生姜有轻微的副作用，那么就会有另外三个人加入到研究中，他们的剂量与引起轻微副作用的剂量相同。同样，如果两个人在相同剂量的生姜中出现了小的副作用，我们将停止研究。产生小副作用的姜的剂量是安全的最高剂量。可以参加这项研究的人需要至少18岁，没有疾病，没有服用药物，除了避孕药。在开始研究之前，每个参与研究的人都将签署一份同意书，其中解释了研究期间将发生的事情。研究中的每个人在服用生姜剂量后将在密歇根大学医院呆10个小时。在密歇根大学医院住院10小时之前，你必须禁食8小时。在服用姜前取一汤匙血，然后在服用姜后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小时取一汤匙血。此外，参与研究的每个人都将在24、48和72小时后返回医院抽血。