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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ruta C group | Experimental | Drug: Rutin + Vitamin C - Oral, two tablets containing 60 mg Rutin + 160 mg Vitamin C, three times daily for 12 weeks, plus lifestyle intervention (Mediterranean diet and structured exercise). |
|
| Vitamin C group | Experimental | Drug: Vitamin C - Oral capsules, 500 mg, twice daily for 12 weeks, plus lifestyle intervention (Mediterranean diet and structured exercise). |
|
| Control group | Experimental | Behavioral: Lifestyle Intervention - Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, and structured exercise program for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rutin + Vitamin C | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| • Change in tumor necrosis factor-alpha (TNF-α) levels from baseline to week 12. | Serum TNF-α, a key biomarker of inflammation in MASLD | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| • 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. | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shaimaa s Bashoaib, master | Contact | +201091316484 | shaimaa.salem22@pharma.asu.edu.eg | |
| Sarah M Fahmy, Asso Prof | Contact | +201127666522 | sarah.farid@pharma.asu.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Sara M Zaki, Professor | Ain Shams University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Hepatology and Tropical Medicine Research Institute (NHTMRI) | Cairo | Egypt |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012431 | Rutin |
| D001205 | Ascorbic Acid |
| D004032 | Diet |
| D015444 | Exercise |
| ID | Term |
|---|---|
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 |
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|
| Vitamin C 500mg | Drug | Type: Drug (Single agent) Oral administration of Vitamin C 500 mg, taken twice daily for 12 weeks |
|
|
| Lifestyle Intervention | Behavioral | Mediterranean diet focusing on fruits, vegetables, whole grains, healthy fats, plus structured exercise program for 12 weeks. |
|
|
| Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |