Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis

Not Applicable

• Conditions: Nonalcoholic Steatohepatitis; Liver Steatosis
• Interventions: Dietary Supplement: Nigella Sativa; Dietary Supplement: Placebo

• Registration Number: NCT02307344
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-03
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-01
• Last Update Submitted: 2014-12-01
• Study First Posted: 2014-12-04
• Last Update Posted: 2014-12-04
• Study Start: 2015-01
• Primary Completion: 2017-01
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nigella Sativa Supplement	Nigella Sativa	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	Placebo	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel