A Phase IIa Pilot Study to Determine the Safety of an Oral Dose of Green Tea Extract (Polyphenon E®) and Provide Preliminary Evidence to Support Its Efficacy in Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.
研究概览
简要总结
Green tea consists of several components, with most research focusing on the polyphenol fraction. The polyphenol fraction(-)-epigallocatechin-3-gallate (EGCG)has been studied extensively as an anti-inflammatory agent as well as a preventative agent for cancer. It has been shown to effectively reduce the inflammation associated with animal models of inflammatory bowel disease. This clinical trial will determine the ability of EGCG, in the form of Polyphenon E®, to treat patients with mild to moderately severe ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adult male or female with mildly to moderately active ulcerative colitis
排除标准
- •Off prohibited medications for proscribed period of time
- •Evidence of infectious colitis
- •Labs outside of range
- •Pregnancy or lactation
研究组 & 干预措施
Polyphenon E treatment
Polyphenon E® therapy was given for 56 days.
干预措施: Polyphenon E® (Drug)
Placebo
Oral Placebo
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Number of Subjects With a Reduction in the Disease Activity Index of >3, or Clinical Remission.
时间窗: day 56
This Index is a measure of ulcerative colitis severity. The index assesses four variables, which include stool frequency, severity of bleeding, colonic mucosal appearance, and the physician's overall assessment of disease activity. Each variable is scored from 0-3 so that the total index score ranges from 0-12; 0-2: remission; 3-6: mild; 7-10: moderate; \>10: severe UC.
次要结局
未报告次要终点
研究者
Gerald W. Dryden, Jr.
Principal investigator
University of Louisville