Phosphodiesterase Inhibitors, Pentoxifylline, as Adjunctive Therapy in Patients With Ulcerative Colitis.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- changes in Mayo Score Index.
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. Also, it is associated with high risk of colon cancer, so there is a continuous need for introducing new therapies that decrease progression, and hence better outcomes
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
- •Addiction to alcohol and / or drugs
研究组 & 干预措施
Pentoxifylline group
The pentoxifylline group will receive 1 g mesalamine three times daily plus pentoxifylline 400 mg two times daily for 6 months.
干预措施: Pentoxifylline 400 MG (Drug)
结局指标
主要结局
changes in Mayo Score Index.
时间窗: 6 months
The Mayo Score for ulcerative colitis disease activity assesses disease severity and can be used to monitor patients during therapy. This scale uses four parameters to calculate the patient scores from 0-12. The parameters assessed are rectal bleeding, stool frequency, endoscopic findings, and physician assessment. Higher scores mean poor progression. Lower scores mean good progression
次要结局
未报告次要终点
研究者
Mostafa Bahaa
Teaching Assistant
Tanta University