Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis (NASH NAFLD)

December 1, 2014 updated by: Hillel Yaffe Medical Center
The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nigella Sativa Supplement
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
Active Comparator: Patients receiving a placebo tablet
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Nigella Sativa on Liver Triglyceride Concentration
Time Frame: 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.
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect of Nigella Sativa on Improvement in NASH Activity Index
Time Frame: One year
Improvement in Nash activity Index will be measured by the NAFLD Activity Score.
One year
Effect of Nigella Sativa on Fibrosis Staging
Time Frame: One year
Microscopic examination of two liver biopsies at start and end of the study, to determine fibrosis staging.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

January 1, 2017

Study Completion (Anticipated)

January 1, 2017

Study Registration Dates

First Submitted

November 3, 2014

First Submitted That Met QC Criteria

December 1, 2014

First Posted (Estimate)

December 4, 2014

Study Record Updates

Last Update Posted (Estimate)

December 4, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0002-14-HYMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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