Clinical Trial Details

Trial ID: L0429
Source ID: IRCT20121216011763N47
Associated Drug: Curcumin
Title: The effects of curcumin plus piperine supplementation on cardiometabolic risk factors and fibroscan findings in patients with non-alcoholic steatohepatitis (NASH): a randomized doubleblind placebo-controlled trial
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: Non-alcoholic steatohepatitis (NASH). <br>Abnormal results of liver function studies;R94.5
Interventions: Intervention 1: Intervention group: A daily curcumin-piperine capsule(500 mg curcumin+ 5 mg piperine) will receive after meal for 12 weeks. Intervention 2: Control group: A daily placebo capsule(500 mg maltodextrin) will receive after meal for 12 weeks.
Outcome Measures: Triglyceride (TG). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method.;Total Cholesterol (TC). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method.;Low density lipoprotein (LDL). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method.;High density lipoprotein (HDL). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic method.;Weight. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Digital scale.;Waist Circumference (WC). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Non-stretching tape measure.;Body mass index (BMI). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Dividing the weight into kilograms by squared height by meter.;Aspartate aminotransferase (AST). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic photometric method.;Alanine aminotransferase (ALT). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic photometric method.;Hepatic steatosis and fibrosis. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Fibroscan.;Fasting blood sugar (FBS). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzymatic.;Blood pressure. Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Sphygmomonometer.;Serum levels of High sensitive C-reactive protein (Hs-CRP). Timepoint: Before intervention and 12 weeks after intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) kits.nan
Sponsor/Collaborators: Esfahan University of Medical Sciences
Gender: All
Age: 18 years65 years
Phases: Not applicable
Enrollment: 60
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomly, based on the permuted block randomization method, using blocks of 4 that will be blocked based on gender var
Start Date: 14/05/2020
Completion Date: --
Results First Posted: --
Last Update Posted: 15 June 2020
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/47332