Clinical Study to Evaluate Safety and Efficacy of Nitazoxanide in Patients With Ulcerative Colitis.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- change in partial mayo score.
研究概览
简要总结
Ulcerative colitis (UC) is a chronic inflammatory bowel Disease (IBD) that primarily affects the rectum and colon. The severity and persistence of mucosal inflammation are associated with morbidity and mortality.
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, Investigator)
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
- •Age ≥ 18 years
- •Both male and female will be included
- •Mild and moderate UC patients are already diagnosed and confirmed by endoscope and histopathology.
排除标准
- •Breast feeding or pregnancy.
- •Colorectal cancer patients.
- •Patients with severe UC.
- •Patients taking rectal or systemic steroids.
- •Patients taking immunosuppressives or biological therapies.
- •Addiction to alcohol and / or drugs.
- •Known allergy to the studied medications.
研究组 & 干预措施
Control group
Control group, n =35: who will receive 1 g mesalamine three times daily for 3 months.
干预措施: Mesalamine (Drug)
Nitazoxanide group
Nitazoxanide group, n= 35: will receive 1 g mesalamine three times daily plus nitazoxanide 500 mg twice daily for 3 months.
干预措施: Mesalamine (Drug)
Nitazoxanide group
Nitazoxanide group, n= 35: will receive 1 g mesalamine three times daily plus nitazoxanide 500 mg twice daily for 3 months.
干预措施: Nitazoxanide (Drug)
结局指标
主要结局
change in partial mayo score.
时间窗: 3 months
One non-invasive clinical measure for determining the severity of UC is the PMS. The composite score is derived from three subcategories: stool frequency, rectal bleeding, and physician's general assessment. The total score falls between 0 and 9
次要结局
未报告次要终点
研究者
Reham ELshafeiy
Clinical pharmacist
Alexandria University