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 — DRUG
    fenofibrate (145 mg) once daily plus conventional sepsis therapy for 7 days.
  • Silymarin — DRUG
    silymarin 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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