Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis

Nonalcoholic Steatohepatitis Clinical Trial

— NASH NAFLD  

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02307344
• Other study ID #: 0002-14-HYMC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 3, 2014
• Last updated: December 1, 2014
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: December 2014
• Source: Hillel Yaffe Medical Center
• Contact: Saif Abu Mouch, MD
• Phone: 972-506-246-966
• Email: saif[@]hy.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fatty Liver
• Liver Steatosis
• Nonalcoholic Steatohepatitis

Intervention

Dietary Supplement:
• Nigella Sativa

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

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Effect of Nigella Sativa on Improvement in NASH Activity Index	Improvement in Nash activity Index will be measured by the NAFLD Activity Score.	One year	No
Secondary	Effect of Nigella Sativa on Fibrosis Staging	Microscopic examination of two liver biopsies at start and end of the study, to determine fibrosis staging.	One year	No