NCT00889161已完成1 期
Curcumin in Pediatric Inflammatory Bowel Disease: A Forced Dose Titration Study
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease.
研究概览
简要总结
This is a single center, open label forced dose titration study designed to determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease (IBD). This study will provide initial tolerability and safety data in pediatric patients with IBD. Twenty patients with IBD in remission or with mild disease (score <34 on PUCAI or score <30 on the PCDAI) on sulfasalazine or mesalamine aged 8 to 18 years will be enrolled into this study. Each patient will participate in the study for nine weeks. From this study an appropriate dosage will be determined to proceed with a double blinded placebo controlled study.
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
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents eight to eighteen years old
- •Diagnosis of inflammatory bowel disease (IBD) made by a pediatric gastroenterologist based upon history, physical examination, laboratory/radiological studies and gastrointestinal histology
- •Mild disease or in clinical remission based upon PUCAI or PCDAI score (score <34 on the PUCAI or score <30 on the PCDAI)
- •Parent/guardian and participant must be able to attend study visits at screening, baseline, and weeks three, six, and nine
- •Patient must be on a stable dose of IBD medications for at least 3 months
- •Patient must be able to swallow study medication
排除标准
- •Abnormal laboratory values as defined in the protocol
- •History of increased gastrointestinal symptoms ("flare") in the last 3 months
- •Current use (past use of these medications is not an exclusion) of medications such as azathioprine, methotrexate or 6-mercaptopurine used to treat IBD
- •Current use (past use of these medications is not an exclusion) of medications or over-the-counter treatments including but not limited to aspirin, NSAID, botanical treatments (ginger, feverfew, yellow clover, Salix species, Populus species, Betula species, and Gaultheria species), essential fatty acids (flax oil and fish oil). Allowed supplementation includes multivitamin, vitamin D & calcium, folate and vitamin B12, and Iron.
- •Other serious medical conditions such as neurological, liver, kidney, auto- immune or systemic disease.
- •History of gastrointestinal surgery or planned gastrointestinal surgery in the future.
- •Tobacco, alcohol, or illicit drug abuse
- •Planned surgery during the potential study participation time
- •Inability to swallow study medication
结局指标
主要结局
To determine the tolerability of curcumin in pediatric patients with inflammatory bowel disease.
时间窗: 9 Weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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