Ulcerative colitis activity
Conditions
Interventions
Experimental group : 33 patients with ulcerative colitis receive capsules containing saffron concentrate , to be ingested 3x / day fasted (total dose 1.5 g ) for 60 days. Placebo group : 33 patients w
Drug
Dietary supplement
B01.650.940.800.575.100.975.900.166
D05.750.078.562.180
Sponsors
Hospital das Clínicas Universidade Federal de Goiás - GO
Instituto Goiano de Gastroenterologia Ltda
Instituto de Patologia Tropical e Saúde Pública
Hospital das Clínicas Universidade Federal de Goiás - GO
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: patients clinically diagnosed with ulcerative colitis ; changes in the examination of fecal calprotectin ; age greater than 18 years; outpatient care ; both sexes ; Clinically stable ; noninstitutionalized ; have performed biopsy and sigmoidoscopy to confirm the diagnosis ; accept participate.
Exclusion criteria
Exclusion criteria: allergy saffron ; heart disease ; liver disease ; leukopenia ; thrombocytopenia ; pancreatitis ; gallstones ; kidney disease; decompensated diabetes ; pneumonia; sepsis or infection ; pregnant women ; nursing mothers ; patients with difficulty swallowing .
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of the inflammatory profile of the experimental group over the control group, verified using the inflammatory cytokines, fecal calprotectin, biochemical tests, biopsy, intestinal microbiota and anthropometry, based on the observation of a variation of at least 5% in pre and post-intervention measurements. | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduce the activity of the disease over time, verified by the method of evaluation of inflammatory cytokines, fecal calprotectina, and intestinal microbiota, evidenced by the increased remission time of the disease. | — |
Countries
Brazil
Contacts
Public ContactJéssica Aguiar
Hospital das Clínicas de Goiânia
Outcome results
None listed