Clinical Study to Evaluate Safety and Efficacy of Rupatadine in Patients With Ulcerative Colitis.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 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 condition that primarily targets the large intestine. Although substantial progress has been made in treatment modalities-especially with the development of immunomodulatory drugs and biologic therapies-managing UC continues to present significant challenges. At present, there is no definitive cure, and current treatment strategies are largely focused on controlling inflammation, relieving symptoms, and halting disease progression
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Control group
control group (Mesalamine group) who will receive 1 g mesalamine three times daily for 3 months.
干预措施: Mesalamine (Drug)
Rupatadine
(Rupatadine group) will receive 1 g mesalamine three times daily plus 20 mg rupatadine once daily for 3 months.
干预措施: Mesalamine (Drug)
Rupatadine
(Rupatadine group) will receive 1 g mesalamine three times daily plus 20 mg rupatadine once daily for 3 months.
干预措施: Rupatadine (Drug)
结局指标
主要结局
change in partial mayo score
时间窗: 3 months
The Partial Mayo Score (PMS) index will be utilized to ascertain the degree of disease severity. 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
Associate lecturer of clinical pharmacy
Alexandria University