Evaluating the effects of silymarin in patients with ulcerative colitis
Clinical Study Evaluating the Possible Beneficial Effect of Silymarin in Patients With Ulcerative Colitis
This study is testing if adding silymarin to the usual treatment for ulcerative colitis can help adults feel better and improve their symptoms.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tanta University Academic / other |
| Locations | 2 sites (Asyut and 1 other locations) |
| Trial ID | NCT06213857 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the beneficial effects of silymarin in adult patients with ulcerative colitis who are already receiving mesalamine. A total of 44 participants will be randomized into two groups: one receiving mesalamine and azathioprine, and the other receiving the same treatment plus silymarin for three months. The primary outcome will be measured by a decrease in the Mayo score, while secondary outcomes will include changes in fecal calprotectin levels. The trial will be conducted at outpatient clinics in Assiut, Egypt.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a confirmed diagnosis of ulcerative colitis and normal kidney and liver functions.
Not a fit: Patients with significant renal or hepatic impairment, those who are pregnant or breastfeeding, and individuals taking corticosteroids or biological therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new adjunctive treatment option for patients with ulcerative colitis, potentially improving their clinical outcomes.
How similar studies have performed: While the specific use of silymarin in ulcerative colitis is less explored, similar studies investigating adjunctive therapies in inflammatory bowel disease have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Asyut and 1 other locations
- Mabarra Hospital — Asyut, Egypt (Recruiting)
- Rajhy Hospital — Asyut, Egypt (Recruiting)
Study contacts
- Study coordinator: Ahmad A Ahmad Eltayeb, Cl.Ph
- Email: PG_165473@pharm.tanta.edu.eg
- Phone: +201140399467
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.