Clinical Trial Details

Trial ID: L0874
Source ID: IRCT201312132480N5
Associated Drug: Genistein
Title: The effect of genistein supplementation on inflammatory and oxidative indices and lipid profile in non-alcoholic fatty liver patients
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Non alcoholic fatty liver. <br>Fatty (change of) liver, not elsewhere classified;Fatty (change of) liver, not elsewhere classified
Interventions: Intervention 1: Intervention group: 250 mg genistein as capsule once per day for 8 weeksmanufacture company: BOC SCI. Intervention 2: Control group: wheat starch in capsule once a day for 8 weeks.;Treatment - Drugs;Placebo;Intervention group: 250 mg genis
Outcome Measures: Malondialdehyde. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;Liver steatosis. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By fibroscan device.;TNF- alpha. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;IL-6. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;ALT. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;AST. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;HDL. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;LDL. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;Total cholesetrol. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.;Triglyceride. Timepoint: Before intervention and two months after intervention inception. Method of measurement: By serum analysis.Waist circumference. Timepoint: Before and two months after intervention inception. Method of measurement: By tapeline in cm.;Waist circumference. Timepoint: Before and two months after intervention inception. Method of measurement: By scale in KG.
Sponsor/Collaborators: Shiraz University Of Medical Sciences
Gender: All
Age: 18 years70 years
Phases: Phase 3
Enrollment: 100
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Randomization carry out by simple randomization.
Start Date: 11/07/2015
Completion Date: --
Results First Posted: --
Last Update Posted: 22 February 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/2209