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โ† Trials
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Beneficial Effect of Silymarin in Ulcerative Colitis

RecruitingPhase 2Ages 18 Years - 65 YearsAllTanta University
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In plain words

What the trial is, and whether it could suit you

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 โ…  (Control group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50mg/day) for 3 months. * Group โ…ก (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 M

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Silymarin
  • Mesalamine
  • Azathioprine
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Where

2 sites
Mabarra Hospital
Asyut, Egypt
Rajhy Hospital
Asyut, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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