Clinical Trial Details

Trial ID: L0816
Source ID: IRCT201705309472N13
Associated Drug: Saffron
Title: Effect of saffron powder on serum concentration of hs-CRP, TNF-a, MDA, TAC, adiponectin and leptin in patients with non-alcoholic fatty live disease
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: non alcoholic fatty liver disease. <br>Fatty (change of) liver, not elsewhere classified;Fatty (change of) liver, not elsewhere classified
Interventions: Intervention 1: Saffron powder group: One day, one tablet will contain 100 mg of saffron for 3 months (12 weeks). Intervention 2: Placebo group: For a period of 3 months (12 weeks), one tablet will contain 100 mg dextrose malto.;Treatment - Drugs;Treatmen
Outcome Measures: Hs-crp. Timepoint: Before intervention and 3 months after intervention. Method of measurement: ELISA kit in ng / ml.;ALT. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzymatic photometric.;AST. Timepoint: Before intervention and 3 months after intervention. Method of measurement: Enzymatic photometric.Waist to hip ratio (WHR). Timepoint: Before the intervention and three months after the intervention. Method of measurement: calculation.;TNF-a. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ELISA kit in pg / ml.;TAC. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Using the kits and colorimetric method in umol / L.;Adiponectin. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ELISA kit in ng / ml.;Leptin. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ELISA kit in ng / ml.;Malondialdehyde (MDA). Timepoint: Before the intervention and three months after the intervention. Method of measurement: Colorimetric method ng / ml.;Weight. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Digital scale in kilograms.;Body mass index (BMI). Timepoint: Before the intervention and three months after the intervention. Method of measurement: Calculation / in kg / m2.;Waist. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Meter in cm.;Hip circumference. Timepoint: Before the intervention and three months after the intervention. Method of measurement: Meter in cm.;Body fat percentage. Timepoint: Before the intervention and three months after the intervention. Method of measurement: ebody device BIA method.
Sponsor/Collaborators: Deputy of Research of Iran University of Medical Sciences
Gender: All
Age: 18 years65 years
Phases: Phase 2/Phase 3
Enrollment: 76
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive.
Start Date: 26/07/2017
Completion Date: --
Results First Posted: --
Last Update Posted: 22 February 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/10060