Liver Steatosis, Nonalcoholic Steatohepatitis
Conditions
Brief summary
The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.
Interventions
DIETARY_SUPPLEMENTNigella Sativa
DIETARY_SUPPLEMENTPlacebo
Capsules that contain a placebo but look like the Nigella Sativa capsules
Sponsors
Hillel Yaffe Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients suffering from Steatohepatitis * Patients suffering from Liver Steatosis
Exclusion criteria
* Patients suffering from viral hepatitis * Patients with HIV infection * Patients suffering from Wilsons Disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Nigella Sativa on Liver Triglyceride Concentration | One year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effect of Nigella Sativa on Improvement in NASH Activity Index | One year | Improvement in Nash activity Index will be measured by the NAFLD Activity Score. |
| Effect of Nigella Sativa on Fibrosis Staging | One year | Microscopic examination of two liver biopsies at start and end of the study, to determine fibrosis staging. |
Countries
Israel
Contacts
Primary ContactSaif Abu Mouch, MD
Outcome results
None listed