Beneficial Effect of Silymarin in Ulcerative Colitis
Recruiting · NCT06213857 · Interventional (participants receive a specific treatment) · Lead sponsor: Tanta University
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The goal of this clinical trial is to evaluate the possible beneficial effect of silymarin in Ulcerative Colitis adult patients receiving mesalamine. This is trial that will be conducted on 44 adult patients with Ulcerative Colitis. Patients will be enrolled after obtaining an informed consent from them or their guardians. Patients will be recruited from Rajhy Hospital Outpatient Clinics and Health Insurance Outpatient Clinics at Mabarra Hospital in Assiut, Egypt. The patients will be randomized based on hospital admission days into two groups: * Group Ⅰ (Control group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50mg/day) for 3 months. * Group Ⅱ (Silymarin group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50mg/day) + Silymarin (140 mg/day) for 3 months. The primary outcome will be clinical improvement defined as a 2 point or more decrease in the Mayo score from baseline. The secondary outcomes will be the change in the level of fecal calprotectin, superoxide dismutase and TNF-α.
Who can take part
Inclusion criteria
- Adults of both sexes aged from 18 years to 65 years.
- Adults with normal kidney and liver functions.
- Patients who sign the consent and willing to participate in the study.
- Patients with UC according to American College of Gastroenterology Clinical Guidelines for diagnosis Ulcerative Colitis having clinical signs and symptoms with a completed medical workup, colonoscopy, pathological and laboratory data confirming UC
Exclusion criteria
- Previous hypersensitivity or anaphylactic reaction to silymarin.
- Significant renal and hepatic impairment.
- Patients who refuse to participate.
- Pregnant women, breastfeeding women and smokers.
- Patients taking corticosteroids or biological therapy.
- Patients taking any other antioxidants.
- Patients having other concomitant diseases where oxidative stress is involved in the etiology such as chronic liver disease, pulmonary infection.
Where it is running
2 locations listed.
- Mabarra Hospital - Asyut, Egypt
- Rajhy Hospital - Asyut, Egypt