Ulcerative Colitis
Conditions
Brief summary
This study evaluates the therapeutic role of Rutin (a plant-derived flavonoid) in reducing the severity of Ulcerative Colitis (UC). The study investigates whether Rutin can decrease intestinal inflammation and improve clinical symptoms by inhibiting the NLRP3 inflammasome signaling pathway, which is activated by oxidative stress in the colon.
Interventions
DRUGRutin 500 MG Oral Tablet
Oral capsules twice daily for 30 days
DIAGNOSTIC_TESTFecal Calprotectin
Sample collection only for baseline comparison.
DRUGPlacebo
Placebo tablets for 30 days
Sponsors
Benha University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of UC confirmed by endoscopy/histology. * Age 18 to 65 years.
Exclusion criteria
* Pregnancy or breastfeeding. * Known hypersensitivity to Rutin. * Presence of other serious systemic diseases (e.g., malignancy, severe hepatic or renal failure).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success Rate of Clinical Improvement | Day 30 (End of treatment) | The percentage of participants who achieve clinical improvement at the end of the treatment period. Clinical improvement is defined as reaching a score of 5 or less on the Simple Clinical Colitis Activity Index (SCCAI). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fecal Calprotectin Levels | Baseline and Day 30 | The concentration of Fecal Calprotectin measured in stool samples to quantify the reduction in intestinal inflammation. |
Countries
Egypt
Outcome results
None listed