Clinical Trial Details

Trial ID: L0826
Source ID: IRCT2017012232109N1
Associated Drug: Nigella sativa
Title: The clinical trial of evaluation of the effect of black cumin (nigella sativa) extract supplementation on serum levels of some inflammatory markers, liver enzymes, lipid profile ,insulin and fasting plasma glucose in patients with non-alcoholic fatty live
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Non alcholic fatty liver. <br>Fatty (change of) liver, not elsewhere classified;Fatty (change of) liver, not elsewhere classified
Interventions: Intervention 1: Intervention group: Black Seed Oil, 1000 mg capsule, once a day for 8 weeks. Intervention 2: Control group: paraffin oil, 1000 mg capsule, once a day for 8 weeks.;Treatment - Other;Placebo;Intervention group: Black Seed Oil, 1000 mg capsul
Outcome Measures: Tumor necrosis factor. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Interleukin 6. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Liver enzymes(aspartate aminotransfrase,alanin aminotransferase,gama glutamil transferase). Timepoint: before and 8 weeks after intervention. Method of measurement: Labratory kits.;C reactive protein. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Lipid profiles(triglycrid,HDL,LDL and total chollestrol). Timepoint: before and 8 weeks after intervention. Method of measurement: Labratory kits.;Insulin. Timepoint: before and 8 weeks after intervention. Method of measurement: ELISA.;Fast blood sugar. Timepoint: before and 8 weeks after intervention. Method of measurement: Enzymatic chlorometric method.Waist to hip ratio. Timepoint: before and 8 weeks after intervention. Method of measurement: Inelastic tape without putting pressure on the body.;Body mass index. Timepoint: before and 8 weeks after intervention. Method of measurement: The ratio of weight in kilograms by the square of height in meters.;Systolic and diastolic blood pressure. Timepoint: before and 8 weeks after intervention. Method of measurement: Sphygmomanometer.
Sponsor/Collaborators: Vice Chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Gender: All
Age: 20 years60 years
Phases: Phase 2
Enrollment: 44
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Sealed envelope method.
Start Date: 12/03/2017
Completion Date: --
Results First Posted: --
Last Update Posted: 22 February 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/25099