Evaluating the effects of silymarin in patients with ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.