NCT06213857RecruitingPhase 2
Beneficial Effect of Silymarin in Ulcerative Colitis
Clinical Study Evaluating the Possible Beneficial Effect of Silymarin in Patients With Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 5 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 9 Jan 2024
- Start date
- Feb 2025
- Primary completion date
- May 2025
- Lead sponsor
- Tanta University
- Diseases
- Ulcerative colitis
- NCT number
- NCT06213857
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 44
- From Feb 2025 to the primary completion date, May 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous hypersensitivity or anaphylactic reaction to silymarin.
- Patients taking corticosteroids or biological therapy.
- Patients having other concomitant diseases where oxidative stress is involved in the etiology such as chronic liver disease, pulmonary infection.
Other illness
- Significant renal and hepatic impairment.
Other
- Patients who refuse to participate.
- Pregnant women, breastfeeding women and smokers.
- Patients taking any other antioxidants.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Mabarra Hospital Coordinator of this site? Confirm its status | Asyut | Egypt | Recruiting |
| Rajhy Hospital Coordinator of this site? Confirm its status | Asyut | Egypt | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.