Actively Recruiting
Beneficial Effect of Silymarin in Ulcerative Colitis
Led by Tanta University · Updated on 2025-03-05
44
Participants Needed
2
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Beneficial Effect of Silymarin in Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Mabarra Hospital
Asyut, Egypt, 71511
Actively Recruiting
2
Rajhy Hospital
Asyut, Egypt, 71511
Actively Recruiting
Research Team
A
Ahmad A Ahmad Eltayeb, Cl.Ph
CONTACT
D
Dalia R Mohammed ElAfify, Asst.Prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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