NCT01231217Unknown不适用
Green Tea in Crohn's Disease
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Crohn's Disease Activity Index
研究概览
简要总结
The purpose of this study is to assess whether green tea or coffee influence the course and life quality of patients with mild to moderately active Crohn's disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men ≥ 18 years with signed informed consent,
- •Patients with proven Crohn's disease,
- •Chronic-active course ≥ 3 months,
- •Current CDAI ≥ 150 and ≤ 350,
- •All medications for Crohn's disease have to be on a constant dosage for at least 4 weeks prior to study entry (i.e. 5-ASA, steroids),
- •Ability of the participant to understand character and individual consequences of the study.
排除标准
- •Pregnancy or the wish to become pregnant, breastfeeding,
- •Concomitant treatment with methotrexate, azathioprine or 6-mercaptopurine for < 3 months,
- •Treatment with TNF-alpha-antagonists, cyclosporine or tacrolimus < 4 weeks prior to study entry,
- •Participation in another study within the last 4 weeks,
- •Ulcerative colitis or indeterminate colitis,
- •Infectious colitis, including cytomegalovirus or Clostridium difficile induced colitis,
- •Colitis for other reasons like known diverticulitis, radiation colitis, ischemic colitis or microscopic colitis,
- •Malabsorption syndromes, lactose intolerance, celiac disease, exocrine pancreas insufficiency,
- •Bleeding hemorrhoids,
- •Other inflammatory or bleeding disorders of the colon and intestine, or diseases that may cause diarrhea or gastrointestinal bleeding,
- •Intolerance / aversion to tea and/or coffee,
- •Current treatment with antibiotics.
结局指标
主要结局
Crohn's Disease Activity Index
时间窗: week 16
Assessment of clinical activity
次要结局
- Harvey-Bradshaw-Index(week 16)
- Inflammatory Bowel Disease Questionnaire(week 16)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Green Tea Consumption and Coronary Heart DiseaseCardiovascular DiseasesCoronary DiseaseHeart DiseasesNCT00005548National Heart, Lung, and Blood Institute (NHLBI)
已完成
2 期
Study of Polyphenon E in Men With High-grade Prostatic Intraepithelial NeoplasiaProstatic HyperplasiaNCT00596011H. Lee Moffitt Cancer Center and Research Institute97
尚未招募
2 期
Effectiveness of green tea based mouth rinse on oral health status, pain and Quality of lifeCTRI/2024/05/067571AIIMS NEW DELHI
招募中
2 期
The effect of green tea on the treatment of depressioHIV.Unspecified human immunodeficiency virus [HIV] diseaseIRCT2017071128308N2Vice chancellor for research Tehran University of Medical Sciences50
招募中
不适用
Clinical study on the effects of green tea components on sleep and stressHealthy personJPRN-UMIN000046109niversity of Shizuoka80