A novel treatment for ulcerative colitis with purastat
Recruiting
- Conditions
- Ulcerative colitis
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- 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
Exclusion Criteria
- 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 6)History of hypersensitivity to peptide or protein preparations6) Other patients who are deemed unsuitable for registration by the physician in charge. 7)Those who are deemed unsuitable for registration by the physician in charge
Study & Design
- Study Type
- Interventional
- Study Design
- single assignment
- Primary Outcome Measures
Name Time Method Percentage of remission Remission: After allowing for a decrease from baseline. 0 or 1 in Mayo endoscopic score
Percentage improvement from baseline in Mayo endoscopic score at 2, 3, and 4 endoscopies Improvement: decrease in Mayo endoscopic score from baseline
- Secondary Outcome Measures
Name Time Method Clinical severity (partial mayo score) improvement Improvement: decrease of at least 1 point from baseline
Clinical severity (partial mayo score) remission Remission: total of 2 points or less and none of the subscores exceed 1
Pathological severity (NANCY index) improvement Improvement: decrease of at least 1 point from baseline
Pathological severity (NANCY index) remission Remission:After allowing for a decrease from baseline. NANCY index of 0 or 1
Change from baseline in Hb Difference between pre and post values
Change from baseline in CRP Difference between pre and post values
Change from baseline in LRG Difference between pre and post values