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Not Yet Recruiting NCT07863648

Vitamin E Versus Silymarin in Non Diabetic MASLD Patients

Conditions: MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 120
Sponsor: Kafrelsheikh University

Location: Faculty of Medicine Tanta

Summary

MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), is a chronic liver condition marked by excessive fat buildup (steatosis) in liver cells, linked to at least one metabolic risk factor like obesity, type 2 diabetes, high blood lipids, or hypertension. Vitamin E serves as a recommended antioxidant therapy for select MASLD patients. It reduces liver inflammation markers such as ALT and AST, alongside benefits in steatosis and MASH resolution. Silymarin has clinical evidence supports its use as an adjunctive hepatoprotective agent due to antioxidant, anti-inflammatory, and antifibrotic effects.

Eligibility Criteria

Inclusion Criteria: * Adults (18-65 y), * Diagnosed with MASLD (CAP ≥248 dB/m on FibroScan, ALT \>40 IU/L), * Non-diabetic (HbA1c \30 g/d men). Exclusion Criteria: * Cirrhosis (LSM \>12 kPa), * Decompensated liver disease, * Other liver diseases, decompensated cirrhosis, * Pregnancy, or * use of vitamin E/silymarin within 3 months.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07863648). StuddyBuddy aggregates publicly available trial information.