Clinical Trial Details

Trial ID: L0796
Source ID: IRCT20090804002288N13
Associated Drug: Nigella sativa
Title: Comparison of the effects of Nigella sativa seed oil mixed with honey and placebo on the hepatic sonography and blood biochemical parameters of non-alcoholic fatty liver disease patients
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified
Interventions: Intervention 1: Intervention group: sixty patients use 2.5 mL of Nigella sativa seed oil orally every 12 hours for 3 months. Intervention 2: Control group: sixty patients use 2.5 mL of placebo orally every 12 hours for 3 months.
Outcome Measures: Fatty liver grade. Timepoint: Before intervention and 3 month? after intervention. Method of measurement: Liver sonography.;Blood level of ALT. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Medical laboratory (kit).;Blood level of AST. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Medical laboratory (kit).;Blood level of LDL-C. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Medical laboratory (kit).;Blood level of triglyceride. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Medical laboratory (kit).Blood level of HDL-C. Timepoint: Before intervention and 3 month after intervention. Method of measurement: Medical laboratory (kit).
Sponsor/Collaborators: Iranian academic center for education culture and research
Gender: All
Age: 20 years70 years
Phases: Not applicable
Enrollment: 120
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization with computer generated random numbers table and sequentially numbered containers each representin
Start Date: 06/06/2018
Completion Date: --
Results First Posted: --
Last Update Posted: 16 July 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/31332