Rutin Therapy Reduces Ulcerative Colitis Disease Activity By Inhibiting The NOD-Like Receptor Protein 3 (NLRP3) Inflammasome: A Molecular Assessment in an Interventional Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Success Rate of Clinical Improvement
研究概览
简要总结
This study evaluates the therapeutic role of Rutin (a plant-derived flavonoid) in reducing the severity of Ulcerative Colitis (UC). The study investigates whether Rutin can decrease intestinal inflammation and improve clinical symptoms by inhibiting the NLRP3 inflammasome signaling pathway, which is activated by oxidative stress in the colon.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of UC confirmed by endoscopy/histology.
- •Age 18 to 65 years.
排除标准
- •Pregnancy or breastfeeding.
- •Known hypersensitivity to Rutin.
- •Presence of other serious systemic diseases (e.g., malignancy, severe hepatic or renal failure).
研究组 & 干预措施
Active Ulcerative Colitis (UC-A)
干预措施: Rutin 500 MG Oral Tablet (Drug)
Active Ulcerative Colitis (UC-A)
干预措施: Fecal Calprotectin (Diagnostic Test)
Remission Ulcerative Colitis (UC-B)
干预措施: Fecal Calprotectin (Diagnostic Test)
Remission Ulcerative Colitis (UC-B)
干预措施: Placebo (Drug)
Healthy Control (Group C)
干预措施: Fecal Calprotectin (Diagnostic Test)
结局指标
主要结局
Success Rate of Clinical Improvement
时间窗: Day 30 (End of treatment)
The percentage of participants who achieve clinical improvement at the end of the treatment period. Clinical improvement is defined as reaching a score of 5 or less on the Simple Clinical Colitis Activity Index (SCCAI).
次要结局
- Change in Fecal Calprotectin Levels(Baseline and Day 30)
研究者
Raafat R. Mohammed
Assistant consultant of Clinical Pathology
Benha University