NCT02307344

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 3, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

December 4, 2014

Status Verified

December 1, 2014

Enrollment Period

2 years

First QC Date

November 3, 2014

Last Update Submit

December 1, 2014

Conditions

Nonalcoholic SteatohepatitisLiver Steatosis

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Secondary Outcomes (2)

  • Effect of Nigella Sativa on Improvement in NASH Activity Index

    One year

  • Effect of Nigella Sativa on Fibrosis Staging

    One year

Study Arms (2)

Nigella Sativa Supplement

ACTIVE COMPARATOR

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

Patients receiving a placebo tablet

ACTIVE COMPARATOR

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

Interventions

Nigella SativaDIETARY_SUPPLEMENT
Nigella Sativa Supplement
PlaceboDIETARY_SUPPLEMENT

Capsules that contain a placebo but look like the Nigella Sativa capsules

Patients receiving a placebo tablet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients suffering from Steatohepatitis
  • Patients suffering from Liver Steatosis

You may not qualify if:

  • Patients suffering from viral hepatitis
  • Patients with HIV infection
  • Patients suffering from Wilsons Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseFatty Liver

Interventions

Nigella sativa oil

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System Diseases

Central Study Contacts

Saif Abu Mouch, MD

CONTACT

972-506-246-966saif@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2014

First Posted

December 4, 2014

Study Start

January 1, 2015

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

December 4, 2014

Record last verified: 2014-12

Locations

IL(1)