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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。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。我们将检查所有剂量的生姜的安全性。此外，我们还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。每个剂量将有三人，加上最高剂量的六人。生姜的六剂剂量分别为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严重的副作用，我们将停止这项研究。低于引起不良副作用的剂量的生姜剂量将是安全的最高生姜剂量。如果一个人对生姜产生了轻微副作用，则将另外三人加入到研究中，其剂量与引起该轻微副作用的剂量相同。另外，如果两个人服用相同剂量的生姜出现轻微副作用，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生姜剂量。 可以参加这项研究的人必须年满 18 岁、没有疾病并且没有服用除节育药物外的任何药物。在开始研究之前，参与研究的每个人都将签署一份同意书，其中解释了研究期间将发生的情况。 研究中的每个人在服用生姜剂量后都将在密歇根大学医院停留 10 个小时。在入住密歇根大学医院 10 小时之前，您必须禁食 8 小时。在服用生姜之前，然后在服用生姜后15分钟、30分钟、45分钟、1小时、2小时、4小时、6小时、8小时和10小时时，抽取一汤匙血液。此外，研究中的每个人都会在 24、48 和 72 小时返回医院抽血。