Beneficial Effect of Silymarin in Ulcerative Colitis
Phase 2 · Testing Silymarin, Mesalamine and Azathioprine · 2 sites · Tanta University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Silymarin (a dietary supplement), Mesalamine (a drug) and Azathioprine (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 18 to 65
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 1 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 44 participants are expected to take part.
- Start date: 2025-02-01.
- Main results expected around 2025-05 (estimate from the record).
- 2 study sites listed (2 marked recruiting) in Egypt.
Main thing being measured
- 2 points or more decrease in the Mayo score from baseline (baseline, 3 months)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Tanta University |
| Enrollment | 44 (estimated) |
| Start date | 2025-02-01 |
| Primary completion (est.) | 2025-05 |
| First posted | 2024-01-19 |
| Last updated | 2025-03-05 |
| Official title | Clinical Study Evaluating the Possible Beneficial Effect of Silymarin in Patients With Ulcerative Colitis |
| ClinicalTrials.gov ID | NCT06213857 |
Interventions
- Silymarin (Dietary Supplement)
Silymarin (milk thistle), an extract obtained from Silybum marianum seeds containing a complex of flavonolignans with a potent intracellular antioxidant property. The first usage of Milk thistle was for its hepatoprotective and antioxidant activities, but in the recent years it has been used to control of immune based murine colitis by healing of bowel histology and reduction of bowel inflammatory… - Mesalamine (Drug)
A 5-aminosalicylic acid compound used in the treatment of mild to moderate ulcerative colitis, with high rates of efficacy in induction and maintenance of remission. - Azathioprine (Drug)
An immunosuppressive medication that is used for the treatment of inflammatory bowel disease (Crohn's disease and ulcerative colitis). It works by decreasing the activity of the body's immune system so it will not attack itself.
Full eligibility criteria (from the record)
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.
Locations (2)
| Site | City | Country | Site status |
|---|---|---|---|
| Mabarra Hospital | Asyut | Egypt | Recruiting |
| Rajhy Hospital | Asyut | Egypt | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.