| Trial ID: | L0491 |
| Source ID: | IRCT20100524004010N25
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| Associated Drug: |
Nigella sativa
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| Title: |
The effect of Nigella sativa consumption on lipid profile, liver enzymes, inflammatory factors and hepatic steatosis in patients with Non-Alcoholic Fatty Liver Disease(NAFLD)
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
|
| Conditions: |
Non alcoholic fatty liver disease. <br>Other specified inflammatory liver diseases;(K75.8)
|
| Interventions: |
Intervention 1: Intervention group: 2 gr per day nigella sativa daily for 3 months. Intervention 2: Placebo group: 2 gr per day starch daily for 3 months.
|
| Outcome Measures: |
HOMA. Timepoint: Begining and end of the study. Method of measurement: Calculation.;TNF-a. Timepoint: Begining and end of the study. Method of measurement: Elisa.;IL-6. Timepoint: Begining and end of the study. Method of measurement: Elisa.;Hepatic Steatosis. Timepoint: Begining and end of the study. Method of measurement: Ultrasound.;LDL-C. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kit.;HDL-C. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kit.;TG. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kit.;Total Cholesterol. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kit.;Serum Insulin. Timepoint: Begining and end of the study. Method of measurement: Radioimmunoassay.;FBS. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kits.;AST. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kits.;ALT. Timepoint: Begining and end of the study. Method of measurement: Enzymatic methods using a kit.;Total energy intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare.;Carbohydrate intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare.;Protein intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare.;Total fat intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare.;SFA intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare.;PUFA intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare.;MUFA intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare.;Fiber intake. Timepoint: Begining and end of the study. Method of measurement: Recall Questionare.Total energy intake. Timepoint: Begining and end of the study. Method of measurement: Questionnaire.
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| Sponsor/Collaborators: |
Shahid Beheshti University of Medical Sciences, National Nutrition and Food Technology Research
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| Gender: |
All
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| Age: |
18 yearsno limit
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| Phases: |
Not applicable
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| Enrollment: |
50
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomly assigned to receive Nigella sativa or placebo, Blinding description: For randomization pro
|
| Start Date: |
24/07/2018
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| Completion Date: |
--
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| Results First Posted: |
--
|
| Last Update Posted: |
25 February 2019
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| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/4197
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