Clinical Trial Details

Trial ID: L0712
Source ID: IRCT20190819044565N2
Associated Drug: Chicory
Title: The evaluation of the effect of brewed chicory leaf consumption on liver steatosis, enzymes, metabolic syndrome components, oxidative stress markers, C-reactive protein in patients with non-alcoholic fatty liver disease
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: non-alcoholic fatty liver disease. <br>Other diseases of liver
Interventions: Intervention 1: Intervention group: Apart from routine treatment by the gastroenterologist, they will receive 15 grams of chicory leaf daily for 12 weeks and And they will use dietary guidelines for Iranians to keep their diet uniform. Intervention 2: Con
Outcome Measures: Hepatic steatosis. Timepoint: Beginning and end of study (after 12 weeks). Method of measurement: ultrasound.;Alanine transaminase. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Aspartate transaminase. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Gamma-glutamyl transferase. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Alkaline phosphatase. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;High-density lipoprotein. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Low-density lipoprotein. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Triglyceride. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Cholesterol. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;FBS. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Total antioxidant capacity. Timepoint: Beginning and end of study (after 12 weeks). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Superoxide dismutase. Timepoint: Beginning and end of study (after 12 weeks). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Hs-CRP. Timepoint: Beginning and end of study (after 12 weeks). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.Insulin. Timepoint: Beginning and End of Study (Week 12). Method of measurement: ELISA method, BT1500 machine.;HOMA-IR. Timepoint: Beginning and End of Study (Week 12). Method of measurement: Formula.;QUICKI. Timepoint: Beginning and End of Study (Week 12). Method of measurement: Formula.;Albumin. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Creatinine. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Bilirubin total. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;CBC. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Using the cell counter.;Calcium. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Phosphorus. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: Enzymatic method with autoanalysis, BT1500 machine.;Sodium. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: blood sample.;Potassium. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: blood sample.;Mean systolic and diastolic blood pressure. Timepoint: First, Sixth Week and End of Study (Week 12). Method of measurement: blood pressure monitor.
Sponsor/Collaborators: Oroumia University of Medical Sciences
Gender: All
Age: 18 yearsno limit
Phases: Phase 3
Enrollment: 60
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization using Stratified Block Randomization statistical software, Blinding description: The data ana
Start Date: 24/12/2019
Completion Date: --
Results First Posted: --
Last Update Posted: 13 January 2020
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/42751

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D071 Chicory Biological extract -- -- -- Under clinical trials Details
D051 Brewed chicory leaf Herbal medicine -- -- -- Under clinical trials Details
D055 Calcium Chemical drug DB01373 CAST; COMP; CP; BMP4; MGP -- Under clinical trials Details
D080 Citrulline Chemical drug DB00155 -- -- Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details
D182 Insulin Biological drug DB00030 INSR agonist; CPE modulator&product of -- Under clinical trials Details
D199 L-alanine Chemical drug DB00160 KYNU -- Failed in clinical trials Details
D316 S-adenosyl-L-methionine Chemical drug DB00118 GNMT cofactor Antiviral Under clinical trials Details