Clinical Trial Details

Trial ID: L0570
Source ID: IRCT2015052322381N1
Associated Drug: Curcumin
Title: Evaluation of effect of Curcumin on the serum levels of 12-inflammatory cytokines and highly sensitive C-reactive protein level in the patients with Non-alcoholic fatty liver disease (A double-blind, randomized, placebo-controlled trial)
Acronym: --
Status: Not Recruiting
Study Results: No Results Available
Results: --
Conditions: NAFLD. <br>nonalcoholic steatohepatitis;K75.8
Interventions: Intervention 1: Curcumin Phytosome (Meriva) with dose 250 mg/day (phospholipidated curcumin, 250 mg equivalent to 50 mg curcumin). Intervention 2: Curcumin C3 complexTM (500 mg) plus BioperineTM (5 mg, patented extract obtained from black pepper fruits (P
Outcome Measures: NAFLD grade. Timepoint: Before intervention and two months after intervention. Method of measurement: Sonography.;Tumor necrosis factor alpha (TNF-a). Timepoint: Before intervention and two months after intervention. Method of measurement: ELISA.;High-sensitivity C-reactive Protein (hs-CRP). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto-analyzer BT-2000.;Interleukin 6 (IL-6). Timepoint: Before intervention and two months after intervention. Method of measurement: ELISA.;Interleukin 10 (IL-10). Timepoint: Before intervention and two months after intervention. Method of measurement: ELISA.;Monocyte Chemoattractant Protein-1 (MCP-1). Timepoint: Before intervention and two months after intervention. Method of measurement: ELISA.Aspartate Aminotransferase (AST). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.;Alanine Aminotransferase (ALT). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.;Alkaline Phosphatase (ALP). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.;Fasting blood sugar (FBS). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.;Triglyceride (TG). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.;Total cholesterol (TC). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.;High-density lipoprotein cholesterol (HDL-C). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.;Low-density lipoprotein cholesterol (HDL-C). Timepoint: Before intervention and two months after intervention. Method of measurement: Auto Analyzer BT-2000.
Sponsor/Collaborators: Neyshabour University of Medical Sciences
Gender: All
Age: 15 years65 years
Phases: Phase 3
Enrollment: 43
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Two letters were prepared and written on two sheets ?€?A?€? for ?€?curcumin?€? and ?€?B?€? for ?€?control.?€? AABB, AB
Start Date: 17/09/2016
Completion Date: --
Results First Posted: --
Last Update Posted: 5 November 2019
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/19311