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Non-alcoholic fatty liver disease (NAFLD) is a prevalent hepatic manifestation of metabolic syndrome, encompassing a spectrum of liver disorders from steatosis to non-alcoholic steatohepatitis (NASH), with potential progression to advanced fibrosis, cirrhosis, and hepatocellular carcinoma. Given the global health burden of NAFLD, therapeutic interventions targeting its pathophysiological mechanisms are crucial.
A randomized, controlled clinical trial will be conducted over 6 months with 80 participants diagnosed with NAFLD. Participants will be assigned to one of the groups including the Aspirin group (100 mg/day), and Empagliflozin 10 mg once daily. Primary outcomes include changes in liver enzymes, lipid profiles, and Fibroscan results, while secondary outcomes focus on clinical symptoms and metabolic indicators like body weight and waist circumference.
Statistical Analysis: Paired t-tests will compare pre- and post-treatment values within each group, while independent t-tests will assess differences between groups. A significance level of p<0.05 will be used.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aspirin group | Experimental | Participants were received 100 mg of aspirin as oral daily doses for 6 months. |
|
| Dapagliflozin group | Experimental | Participants were received 10 mg of dapagliflozin as oral once-daily doses for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Participants received 100 mg of aspirin (aspirin protect®) as oral daily doses for 6 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| lipid profile and Fibroscan results |
| 6 months |
| lipid profile and Fibroscan evalution |
| 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| indicators of metabolic improvement |
| 6 months |
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Inclusion Criteria: if one or more the following are present:
Exclusion Criteria:Patients were excluded from our study if one or more the -following are present:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy | Banī Suwayf | Beni Suweif Governorate | 0000 | Egypt |
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| Dapagliflozin (10Mg Tab) along with standard medical therapy | Drug | Participants received 10 mg of dapagliflozin (Diaflozimet ®) as oral once-daily doses for 6 months. |
|
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| C529054 | dapagliflozin |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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