NCT02267694已完成1 期
A Trial of Freeze-dried Black Raspberry in Maintenance of Remission of Ulcerative Colitis
UConn Health1 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Remission rate
研究概览
简要总结
This research study is about adding Black Raspberry powder to the treatment regimen of patients with ulcerative colitis who are currently in remission and doing well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (>18 years of age) with known diagnosis of ulcerative colitis who are currently in remission on a stable dose of 5-ASA products and/or steroids (equivalent to prednisone 20 mg or less). English speaking/reading male or female patients from all ethnicities will be considered for the study.
排除标准
- •Treatment with Immunomodulators and/or biologic agents, active disease flare, patients younger than 18 years old, patients who are pregnant or trying to get pregnant, breast feeding and those with reported history of allergy or hypersensitivity to berry products.
- •Patients who are using NSAIDS will also be excluded from the study but low dose ASA (81-162 mg) is permitted if needed.
研究组 & 干预措施
Black raspberry powder
Other
Black raspberry powder 25 grams once daily for 4 weeks. If tolerated, will increase to 25 grams twice a day for another 20 weeks. Total length of active treatment 24 weeks.
干预措施: Freeze-dried black raspberry powder (Drug)
结局指标
主要结局
Remission rate
时间窗: 6 months
次要结局
未报告次要终点
研究者
研究点 (1)
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