Clinical Trial Details

Trial ID: L0571
Source ID: IRCT2016061516123N8
Associated Drug: Melatonin
Title: Evaluation of the effects of Melatonin Supplementation on Hepatic Enzymes, Inflammatory Factors, Lipid profile, blood glucose, Insulin Sensitivity, and Hepatic Steatosis grade in patients with Non-alcoholic fatty liver disease
Acronym: --
Status: Recruiting
Study Results: No Results Available
Results: --
Conditions: Nonalcoholic fatty liver disease (NAFLD). <br>nonalcoholic steatohepatitis;nonalcoholic steatohepatitis
Interventions: Intervention 1: Melatonin, Tab 5 mg, once a dayT 3 months. Intervention 2: Placebo, 5 mg, 3 months.;Treatment - Other;Placebo;Melatonin, Tab 5 mg, once a dayT 3 months;Placebo, 5 mg, 3 months
Outcome Measures: Alanine transaminase. Timepoint: before intervention and after 3 months. Method of measurement: seum level.;Aspartate transaminase. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Tumor necrosis factor alpha. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;High sensitive C reactive protein. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Triglyceride. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Total cholesterol. Timepoint: before intervention and after 3 months. Method of measurement: serum level.;Low density lipoprotein (LDL). Timepoint: before intervention and after 3 months. Method of measurement: serum level.;High density lipoprotein (HDL). Timepoint: before intervention and after 3 months. Method of measurement: serum level.Sleep quality. Timepoint: before and 3 months after intervention. Method of measurement: Pittsburgh sleep quality index questionnaire.
Sponsor/Collaborators: Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences
Gender: All
Age: 18 years60 years
Phases: Not applicable
Enrollment: 50
Study Type: interventional
Study Designs: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.
Start Date: 28/08/2016
Completion Date: --
Results First Posted: --
Last Update Posted: 22 February 2018
Locations: Iran (Islamic Republic of)
URL: http://en.irct.ir/trial/15186