Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis

NCT ID: NCT02307344

Last Updated: 2014-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-01-31

Brief Summary

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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

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Conditions

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Nonalcoholic Steatohepatitis Liver Steatosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Nigella Sativa

Intervention Type DIETARY_SUPPLEMENT

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.

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Nigella Sativa

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Saif Abu Mouch, MD

Role: CONTACT

972-506-246-966

Facility Contacts

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Saif Abu Mouch, MD

Role: primary

972-50-624-6966

Other Identifiers

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0002-14-HYMC

Identifier Type: -

Identifier Source: org_study_id