Clinical Study Evaluating Safety and Efficacy of Pentoxifylline in Patients With Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 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 persistent, idiopathic form of inflammatory bowel disease (IBD) marked by uninterrupted inflammation of the colon's mucosal lining, usually starting at the rectum and progressing proximally in a continuous manner. It manifests clinically with recurrent episodes of abdominal pain, bloody diarrhea, urgency, tenesmus, and weight loss. The precise cause of UC is still unknown; however, it is thought to arise from a multifactorial interaction involving genetic susceptibility, immune system dysregulation, disturbances in gut microbiota composition, and various environmental factors.
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)
盲法说明
Double blinded
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
- •Age ≥ 18 years
- •Both male and female will be included
- •Negative pregnancy test and effective contraception.
- •Mild and moderate UC patients
排除标准
- •Breast feeding
- •Significant liver and kidney function abnormalities
- •Diabetic patients
- •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
Group 1 (Placebo Group): Participants in this arm were administered an inert placebo capsule twice per day, in combination with mesalamine at a total daily dose of 3 g, given as 1 g three times daily
干预措施: Mesalamine (Drug)
Pentoxifylline group
Group 2 (PTX Group): Individuals assigned to this group received PTX at a dose of 400 mg twice daily, together with mesalamine 1 g taken three times daily.
干预措施: Mesalamine (Drug)
Pentoxifylline group
Group 2 (PTX Group): Individuals assigned to this group received PTX at a dose of 400 mg twice daily, together with mesalamine 1 g taken three times daily.
干预措施: Pentoxifylline (Drug)
结局指标
主要结局
Change in partial Mayo score
时间窗: 6 months
The Partial Mayo Score (PMS) was utilized to evaluate disease activity in patients with UC. This non-invasive index comprises three components: stool frequency, rectal bleeding, and the physician's global assessment, yielding a total score between 0 and 9
次要结局
- Change in inflammatory bowel disease questionnaire-32 (IBDQ-32)(6 months)
- Change in level of fecal calprotectin(6 months)
研究者
Ihab Elsayed Hassan
Lecturer
Tanta University