evaluate the combined effects of Rutin and Vitamin C versus Vitamin C alone on selected oxidative stress markers, inflammation, hepatic steatosis regression, and associated metabolic parameters in patients with MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) is a common liver disorder with risks of progression to fibrosis, cirrhosis, and hepatocellular carcinoma. Its global prevalence is high, driven by oxidative stress and impaired antioxidant defenses, while no approved pharmacological treatments currently exist. Nutritional agents such as vitamin C and rutin show promise in improving liver function and reducing oxidative damage. This study will evaluate their combined effects in addressing MASLD's multifactorial pathology.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Type: Drug (Combination therapy) Details: Oral administration of two tablets containing 60 mg Rutin + 160 mg Vitamin C, taken three times daily for 12 weeks.
Type: Drug (Single agent) Oral administration of Vitamin C 500 mg, taken twice daily for 12 weeks
Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, plus structured exercise program for 12 weeks.
National Hepatology and Tropical Medicine Research Institute (NHTMRI)
Cairo, Egypt
• Change in tumor necrosis factor-alpha (TNF-α) levels from baseline to week 12.
Serum TNF-α, a key biomarker of inflammation in MASLD
Time frame: 12 weeks
• Change in serum malondialdehyde (MDA) levels from baseline to week 12.
Malondialdehyde (MDA) is a well-established biomarker of oxidative stress in MASLD, reflecting lipid peroxidation and liver injury.
Time frame: 12 weeks
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