NCT00248053撤回2 期
Use of Curcumin in the Lower Gastrointestinal Tract in Familial Adenomatous Polyposis (FAP) Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- polyp number and size
研究概览
简要总结
The purpose of this study is to assess if curcumin, a commonly used food spice, can regress colorectal adenomatous polyps in patients with familial adenomatous polyposis, an inherited form of colorectal cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Familial adenomatous polyposis
- •18 years of age or older
- •5 or more adenomas of colorectum or ileum
排除标准
- •Female patient of child bearing age not on effective birth control pills
- •Pregnant women
- •White blood cell (WBC) count less than 4000
- •Platelets (Plts) less than 100,000
- •Blood urea nitrogen (BUN) greater than 25
- •Creatine greater than 1.5
- •Patients unable to stop non-steroidal anti-inflammatory drugs (NSAIDs) during duration of trial
- •Malignancy
- •Patient with active bacterial infections of gastroesophageal reflux disease or peptic ulcer disease
- •Patient on warfarin or anti-platelet drugs
研究组 & 干预措施
Lower GI
Other
干预措施: curcumin (Drug)
结局指标
主要结局
polyp number and size
时间窗: one year
次要结局
- side effects and medication compliance(one year)
研究者
Francis M. Giardiello
Professor of Medicine
Johns Hopkins University
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