Back to resultsEffect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis (NASH NAFLD)
Primary Purpose
Nonalcoholic Steatohepatitis, Liver Steatosis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Nigella Sativa
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nonalcoholic Steatohepatitis
Eligibility Criteria
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
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nigella Sativa Supplement
Patients receiving a placebo tablet
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Effect of Nigella Sativa on Improvement in NASH Activity Index
Improvement in Nash activity Index will be measured by the NAFLD Activity Score.
Effect of Nigella Sativa on Fibrosis Staging
Microscopic examination of two liver biopsies at start and end of the study, to determine fibrosis staging.
Full Information
NCT ID
NCT02307344
First Posted
November 3, 2014
Last Updated
December 1, 2014
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02307344
Brief Title
Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis
Acronym
NASH NAFLD
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis, Liver Steatosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nigella Sativa Supplement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patients receiving a placebo tablet
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Nigella Sativa
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Capsules that contain a placebo but look like the Nigella Sativa capsules
Primary Outcome Measure Information:
Title
Effect of Nigella Sativa on Liver Triglyceride Concentration
Description
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
Secondary Outcome Measure Information:
Title
Effect of Nigella Sativa on Improvement in NASH Activity Index
Description
Improvement in Nash activity Index will be measured by the NAFLD Activity Score.
Time Frame
One year
Title
Effect of Nigella Sativa on Fibrosis Staging
Description
Microscopic examination of two liver biopsies at start and end of the study, to determine fibrosis staging.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Saif Abu Mouch, MD
Phone
972-506-246-966
Email
saif@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saif Abu Mouch, MD
Phone
972-50-624-6966
Email
saif@hy.health.gov.il
First Name & Middle Initial & Last Name & Degree
Saif Abu Mouch, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis
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