NCT06213857 Beneficial Effect of Silymarin in Ulcerative Colitis
| NCT ID | NCT06213857 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tanta University |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 44 participants in total. It began in 2025-02-01 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Adults of both sexes aged from 18 years to 65 years. 2. Adults with normal kidney and liver functions. 3. Patients who sign the consent and willing to participate in the study. 4. 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: 1. Previous hypersensitivity or anaphylactic reaction to silymarin. 2. Significant renal and hepatic impairment. 3. Patients who refuse to participate. 4. Pregnant women, breastfeeding women and smokers. 5. Patients taking corticosteroids or biological therapy. 6. Patients taking any other antioxidants. 7. Patients having other concomitant diseases where oxidative stress is involved in the etiology such as chronic liver disease, pulmonary infection.
Contact & Investigator
Sahar M Ghobashy ElHaggar, Professor
STUDY DIRECTOR
Tanta University
Frequently Asked Questions
Who can join the NCT06213857 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06213857 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06213857 currently recruiting?
Yes, NCT06213857 is actively recruiting participants. Contact the research team at PG_165473@pharm.tanta.edu.eg for enrollment information.
Where is the NCT06213857 trial being conducted?
This trial is being conducted at Asyut, Egypt, Asyut, Egypt.
Who is sponsoring the NCT06213857 clinical trial?
NCT06213857 is sponsored by Tanta University. The principal investigator is Sahar M Ghobashy ElHaggar, Professor at Tanta University. The trial plans to enroll 44 participants.
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