| Trial ID: | L0562 |
| Source ID: | IRCT201610269472N11
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| Associated Drug: |
Saffron
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| Title: |
The effect of saffron supplementation on liver enzymes, insulin resistance, lipid profile and The degree of hepatic steatosis in patients with non-alcoholic fatty liver disease: a randomised, double-blind, placebo-controlled study.
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| Acronym: |
--
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| Status: |
Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Nonalcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified;Fatty (change of) liver, not elsewhere classified
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| Interventions: |
Intervention 1: Intervention group: receiving one pill containing 100 mg powder of Saffron daily with meal for 12 weak. Intervention 2: Placebo group: receiving one pill containing 100 mg maltodextrin daily with meal for12 weak.;Treatment - Drugs;Treatme
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| Outcome Measures: |
ALT. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: Enzymatic photometry.;AST. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: Enzymatic photometry.Apo a1. Timepoint: Before intervention and three months after intervention. Method of measurement: Immunoturbidometry.;FBS. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic photometry.;GGT. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic photometry.;Insulin. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: ELISA.;Insulin resistance. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: calculation.;Quicki index. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: calculation.;Lipid profile(LDL-c, HDL-c, TG, total cholestrol). Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic photometry(LDL by calculation).;Systolic and diastolic blood pressure. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: Mercury sphygmomanometer.;Sleep quality. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: The Pittsburgh Sleep Quality questionnaire.;Life quality. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: quality of life sf 12 questionnaire.;Hepatic steatosis. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: ultrasonography.;Liver fibrosis. Timepoint: Before intervention and 12 weak after intervention. Method of measurement: fibroscan.;Direct bilirubin and total bilirubin. Timepoint: Before intervention and three months after intervention. Method of measurement: Enzymatic photometry.
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| Sponsor/Collaborators: |
Vice-chancellor for research Iran University of Medical Sciences
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| Gender: |
All
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| Age: |
18 years65 years
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| Phases: |
Phase 2
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| Enrollment: |
76
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| Study Type: |
interventional
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| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.
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| Start Date: |
22/11/2016
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
22 February 2018
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| Locations: |
Iran (Islamic Republic of)
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| URL: |
http://en.irct.ir/trial/10058
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