Combination of Atorvastatin and Mesalazine to Enhance Anti-inflammatory Effects and Attenuates Progression of Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement in health related quality of life
研究概览
简要总结
Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa; however, the exact underlying mechanisms of UC remain poorly understood. Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering property.
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
- Double (Participant, Care Provider)
盲法说明
double-blinded
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Both male and female will be included
- •Negative pregnancy test and effective contraception
排除标准
- •Breastfeeding
- •Significant liver and kidney function abnormalities
- •Colorectal cancer patients
- •Patients with severe UC
- •Patients taking rectal or systemic steroids
- •Patients taking immunosuppressives or biological therapies
研究组 & 干预措施
Atorvastatin group
This group will take 1 g mesalamine three times daily and atorvastatin 80 mg once daily
干预措施: Atorvastatin 80mg (Drug)
结局指标
主要结局
Improvement in health related quality of life
时间窗: 6 months
HRQL questionnaire will be assessed according to a short-form (SF-36) questionnaire. The SF-36 is an indicator of overall health status and contains 10 items. The SF-36 has eight scaled scores; the scores are weighted sums of the questions in each section. Scores range from 0 - 100.
次要结局
- changes in the level of inflammatory biomarkers(6 months)
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University