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The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nigella Sativa Supplement | Active Comparator | Fifty patients suffering from Nonalcoholic Steatohepatitis or Liver Steatosis will ingest capsules containing 2 grams of Nigella Sativa divided into 1 grams twice a day. |
|
| Patients receiving a placebo tablet | Active Comparator | Twenty patients suffering from Nonalcoholic Steatohepatitis or Liver Steatosis will ingest placebo capsules twice a day, that look like the capsules of those receiving the Nigella Sativa. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nigella Sativa | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Nigella Sativa on Liver Triglyceride Concentration | The difference in change in the average liver triglyceride concentration will be measured by MRI Spectroscopy between the Nigella Sativa arm and the placebo arm, at start and end of the study. | One year |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of Nigella Sativa on Improvement in NASH Activity Index | Improvement in Nash activity Index will be measured by the NAFLD Activity Score. | One year |
| Effect of Nigella Sativa on Fibrosis Staging |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Saif Abu Mouch, MD | Contact | 972-506-246-966 | saif@hy.health.gov.il |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillel Yaffe Medical Center | Hadera | 38100 | Israel |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000723271 | Nigella sativa oil |
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Capsules that contain a placebo but look like the Nigella Sativa capsules |
|
Microscopic examination of two liver biopsies at start and end of the study, to determine fibrosis staging.
| One year |