Clinical Study Evaluating the Efficacy and Safety of Fenofibrates Versus Silymarin in Adult Patients With Sepsis
- Sponsor
- Tanta University
- Study ID
- NCT07572552
- Phase
- PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Sepsis
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fenofibrate — DRUGfenofibrate (145 mg) once daily plus conventional sepsis therapy for 7 days.
- Silymarin — DRUGsilymarin does ranged between (980 - 1120 mg) daily, in divided doses plus conventional sepsis therapy for 7 days.
Study Details
Sepsis is a life-threatening condition defined by organ dysfunction resulting from the body's dysregulated response to an infection (1). It begins with widespread inflammation and cellular damage, which quickly escalates into total circulatory failure and the breakdown of essential organ systems, including the lungs, kidneys, digestive tract, and brain. This study aims at evaluating the safety and efficacy of fenofibrate versus silymarin for adult patients with sepsis.
Key Dates
- First listed
- May 7, 2026
- Start date
- May 31, 2026
- Status verified
- Apr 2026
- Primary completion
- Apr 30, 2027
- Completion
- Apr 30, 2028
Study Design
- Enrollment
- 66 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- No Intervention: Control group
- Experimental: Fenofibrate group
- Experimental: Silymarin group
Primary Outcome Measure
change in the measured biological markers (TNF-α, MDA, and IL-10) [ Time Frame: after seven days ]
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