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Nonalcoholic fatty liver disease (NAFLD) is a global public health concern, and the leading cause of chronic liver disease, especially in developed countries (1). NAFLD is characterized by lipid accumulation in the liver not attributed to other causes. NAFLD is characterized by excessive hepatic fat accumulation without other recognized causes of increased fat content (e.g., alcohol, virus, drugs, and autoimmunity). According to the Clinical Practice Guidelines of the European Association for the Study of the Liver, the diagnosis of NAFLD requires the exclusion of daily alcohol consumption >30 g for men and >20 g for women
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | 25 patients received the standard conventional therapy in addition to placebo for 3 months. |
|
| Cilostazole group | Active Comparator | 25 patients were given the standard conventional therapy plus cilostazol 100 mg two times daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard therapy | Other | • The standard conventional therapy in both groups included regular exercise in the form of any physical activity as walking, cycling, etc. for 30-45 minutes minimum 5 days per week in addition to calorie restriction in overweight and obese patients (1200-1500 and 1000-1200 kcal/day for men and women, respectively). |
| Measure | Description | Time Frame |
|---|---|---|
| The change in the degree of steatosis in the ultra sound and the change in fibrosis risk scores are the primary endpoint. | The change in the degree of steatosis in the ultra sound and the change in fibrosis risk scores are the primary endpoint. | 3 months |
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Inclusion Criteria:
Either male or female adult patients (>18 years) with fatty liver diagnosis by using upper abdominal ultrasound echography (US).
Exclusion Criteria:
Pregnant and/or lactating women, excessive alcohol use (defined as an average alcohol intake > 30 g per day in men and > 20 g per day in women).
Other etiology of chronic liver diseases such as viral hepatitis, drug-induced hepatitis, autoimmune hepatitis.
Patients suffering from chronic kidney disease, hyper/hypoparathyroidism, and congestive heart failure patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mostafa Bahaa | Recruiting | Damietta | New Damietta | 34518 | Egypt |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000077407 | Cilostazol |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| Cilostazol | Drug | Cilostazol is a 2-hydroxyquinolone derivative and a drug approved for improving the claudication distance. Other studies have shown that Cilostazol can ameliorate hepatic steatosis, but the specific mechanism is still unknown |
|
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |