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The aim of the study is to test the implication of esomeprazole as a possible potential therapy for patients with NASH through evaluating its effect on ultrasound and fibrosis risk scores, serum levels of liver fibrosis biomarkers (fibronectin 1), insulin resistance, metabolic and inflammatory parameters.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| esomeprazole group | Experimental | patients in this arm will receive esomeprazole 20 mg once daily |
|
| Placebo group | Placebo Comparator | patients in this arm will receive placebo once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | esomeprazole 20 mg once daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in non-alcoholic fatty liver disease (NAFLD) fibrosis score (NFS) | Increase in NAFLD fibrosis score indicates high probability of advanced liver fibrosis Score lower than -1.5 indicates low probability of advanced liver fibrosis (F0-F2). Score higher than or equals -1.5 to < 0.67 indicates intermediate probability of advanced liver fibrosis. Score higher than or equals 0.67 indicates high probability of advanced liver fibrosis (F3-F4) | Before and after 3 months of the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Liver function improvement | change in the other measured parameters such as liver panel | Before and after 3 months of the intervention |
| Reduction of oxidative stress | Decrease in the serum level of malondialdehyde (MDA) |
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Inclusion Criteria:
Both males and females.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| aya hesham eltabbakh, bachelor | Contact | +201094393402 | aya.eltabaakh@fop.usc.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Liver Institute | Recruiting | Shibīn al Kawm | Egypt |
Data will be supplied upon a reasonable request
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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 |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Placebo |
| Drug |
Placebo once daily |
|
| Before and after 3 months of the intervention |
| D009930 |
| Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |