Repurposing Atorvastatin in Patients With Ulcerative Colitis Treated With Mesalamine by Modulation of mTOR/NLRP3 Pathway.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Improvement in health related quality of life
研究概览
简要总结
Statins exert numerous pleiotropic effects including anti-inflammatory, antioxidant properties, endothelial function improvement, and immunomodulation independent of their basic lipid-lowering properties.
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 males and females 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
Control Group
This group will take mesalamine 1 g three times daily
干预措施: Mesalamine (Drug)
Atorvastatin group
This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily.
干预措施: Atorvastatin 80mg (Drug)
Atorvastatin group
This group will take mesalamine 1 g three times daily plus atorvastatin 80 mg once daily.
干预措施: Mesalamine (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 bowel symptoms, emotional symptoms, systemic symptoms, and social symptoms
次要结局
- changes in serum and fecal inflammatory biomarkers(6 months)
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University