An interventional study of Nigella Sativa and Placebo in Nonalcoholic Steatohepatitis and Liver Steatosis, sponsored by Hillel Yaffe Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-04.
Sponsored by Hillel Yaffe Medical Center · Not applicable, Interventional, and Treatment
The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.
1,451 studies on the registry are indexed under Fatty Liver; 292 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 1,003 interventional studies indexed under Fatty Liver.
Browse Fatty Liver studies →Hillel Yaffe Medical Center is the lead sponsor of 301 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: Nigella Sativa
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.
Dietary Supplement: Placebo
Capsules that contain a placebo but look like the Nigella Sativa capsules
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.
Time frame: One year
Effect of Nigella Sativa on Improvement in NASH Activity Index
Improvement in Nash activity Index will be measured by the NAFLD Activity Score.
Time frame: One year
Effect of Nigella Sativa on Fibrosis Staging
Microscopic examination of two liver biopsies at start and end of the study, to determine fibrosis staging.
Time frame: One year
This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Hillel Yaffe Medical Center