jRCTs032230119招募中不适用
A novel treatment for ulcerative colitis with purastat: A single-center prospective interventional study
未提供0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 主要终点
- Percentage improvement from baseline in Mayo endoscopic score
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 85age old under（—）
- 性别
- All
入选标准
- •Ulcerative colitis between the ages of 18 and 85 at the time of enrollment
- •Patients with mild to moderate disease on the Partial Mayo score
- •Patients who understand the contents of the consent document and give free written consent
排除标准
- •Those with concurrent infectious or drug-induced enteritis
- •Pregnant or possibly pregnant
- •Those who are breast-feeding
- •Patients with abnormal blood coagulation function
- •Patients with severe organ failure
- •History of hypersensitivity to peptide or protein preparations6) Other patients who are deemed unsuitable for registration by the physician in charge.
- •Those who are deemed unsuitable for registration by the physician in charge
结局指标
主要结局
Percentage improvement from baseline in Mayo endoscopic score
时间窗: at 2, 3, and 4 endoscopies
Improvement: decrease in Mayo endoscopic score from baseline
Percentage of remission
Remission: After allowing for a decrease from baseline. 0 or 1 in Mayo endoscopic score
次要结局
- Clinical severity (partial mayo score) improvement
- Clinical severity (partial mayo score) remission
- Pathological severity (NANCY index) improvement
- Pathological severity (NANCY index) remission
- Change from baseline in Hb
- Change from baseline in CRP
- Change from baseline in LRG
研究者
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