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临床试验/NCT01845220
NCT01845220已完成2 期

Prevention of Alcohol Intolerance

Johns Hopkins University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
30
试验地点
1
主要终点
Mean Area of Skin Erythema (Skin Redness)

研究概览

简要总结

This study is designed to determine whether Asians who are especially sensitive to alcohol exposure can be protected by boosting their activities of an alcohol disposing enzyme. This will be accomplished by administering broccoli sprouts that are rich in an agent that increases protective enzyme activity. The test system involves applying alcohol patches to the skin and measuring skin redness.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-70 years old,
  • sensitive to alcohol on the skin, Japanese

排除标准

  • recent skin abnormalities /tanning

研究组 & 干预措施

Broccoli Sprout Extract

Active Comparator

Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.

干预措施: Broccoli Sprout Extract (Drug)

Placebo

Placebo Comparator

Each subject will act as his/her own control and receive both treatment and placebo on adjacent skin regions.

干预措施: Placebo (Drug)

结局指标

主要结局

Mean Area of Skin Erythema (Skin Redness)

时间窗: mean up to 2 hours

For three days in a row, volunteers will receive skin treatments with broccoli sprout extract. On day four, their skin will be measured for a baseline skin color reading. Immediately following this reading, the treated areas of the skin will be challenged with 70 percent alcohol and the redness of the skin will again be measured every 30 minutes for the following two hours for skin color changes. The values were collected every 30 minutes after the alcohol skin challenge for 2 hours and were averaged. Mean and 95% Confidence Interval are reported.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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