Effect of saffron solution on ulcerative colitis
Early Phase 1
- Conditions
- lcerative Colitis.Ulcerative colitis
- Registration Number
- IRCT20190701044062N5
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Patients who's disease is diagnosed recently or recent relapce
Patients who can tolerate enema
Exclusion Criteria
Patients with good controlled disease
Patients who can't tolerate enema
Patients with associated disease: Crohn, Intermediate colitis, CMV, Pseudomembrano colitis, Heart failure, Renal failure, PSC
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Disease activity based on Mayo score. Timepoint: Assessment of disease activity at the beginning of the study and 28 days after the start of saffron enema solution. Method of measurement: Mayo Score.
- Secondary Outcome Measures
Name Time Method Frequent defecation. Timepoint: Evaluation of stool frequency at the beginning of the study and 28 days after starting saffron enema solution. Method of measurement: Mayo Score.;Rectal bleeding. Timepoint: Evaluation of rectal bleeding at the beginning of the study and 28 days after starting saffron enema solution. Method of measurement: Mayo score.;Endoscopic findings. Timepoint: Evaluation of endoscopic findings at the beginning of the study and 28 days after starting saffron enema. Method of measurement: Mayo score.