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IRCT20170609034406N2 IRCT 2018-08-29 Tabriz University of Medical Sciences Effect of omega-3 fatty acids on uremic pruritus Effects of omega-3 fatty acids on uremic pruritus in chronic hemodialysis patients 2016-11-21 anticipated 60 Complete https://irct.ir/trial/26293 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, Permuted Block Randomization method was used for entering patients in control and treatment groups. In this method, each block contained an equal number of treatment groups and control group. Random numbers in this study were given using the Excel program to determine random blocks and random groups, Blinding description: This study was conducted in a single blind clinical trial. None of the people distributing drugs and patients were aware of which patients received the drug or placebo, and were only diagnosed with the numbers given by the system to the patients. N/A Condition 1: Pruritus. Condition 2: End Stage Renal Disease. Intervention 1: The treatment group consists of 30 patients receiving 1200 mg of omega-3 fatty acids daily for 3 months. Intervention 2: The control group consisted of 30 patients who received 1200 mg orally daily for a period of 3 months, which, apart from the active ingredient, were similar to omega-3 capsules. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Afshin Gharekhani
Faculty of Pharmacy , Tabriz University of Medical Sciences , Daneshgah Street , Tabriz , Iran
Tabriz Iran (Islamic Republic of) 5147663419 +98 41 3230 5153 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Afshin Gharekhani
Faculty of Pharmacy , Tabriz University of Medical Sciences , Daneshgah Street , Tabriz , Iran
Tabriz Iran (Islamic Republic of) 5147663419 +98 41 3230 5153 gharekhania@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria:Age over 18 years ; Beginning hemodialysis for at least 3 months and three times per week ; Ability to understand and sign consent form ; Use of biocompatible dialysis membrane. Properly functioning arteriovenous fistula or catheter function; Dialysis adequacy above 1.2. 18 years no limit Both Exclusion criteria : Other causes of itching, except kidney failure ; Pregnancy ; The presence of any chronic, active, uncontrolled or severe chronic inflammatory disease (autoimmune diseases, connective tissue disease, malignancy, HIV, liver disease and pulmonary disease) ; presence of chronic infection or acute infection in the last month ; Hemoglobin less than 10 g / dL ; Co-presence in another trial ; Medical history (such as heart attack ) or surgical in the last 3 months ; Symptoms of malabsorption ; Bleeding disorders ( Includes coagulopathies) or high risk of bleeding ; Change in diet in the last 1 month; Consumption of Omega-3 or any supplement containing omega-3 in the last 3 months. ; Intolerance or susceptibility to drug ; Receiving drugs that have an effect on inflammatory factors (corticosteroids or other immunosuppressive drugs, non-steroidal anti-inflammatory drugs, contraceptives, pentoxifylline) in the last 6 weeks; Concomitant use of methyl dopa, cimetidine and serotonergic drugs such as triptans, tramadol, tryptophan and linzolide ; Use of warfarin ; Abuse of alcohol and other substances that cause dependence. L29.8 N18.5 Other pruritus Chronic kidney disease, stage 5 Treatment - Drugs Placebo The treatment group consists of 30 patients receiving 1200 mg of omega-3 fatty acids daily for 3 months. The control group consisted of 30 patients who received 1200 mg orally daily for a period of 3 months, which, apart from the active ingredient, were similar to omega-3 capsules. Pruritus score. Timepoint: Before intervention. Six weeks after the intervention. At the end of the intervention. Method of measurement: Standard questionnaire. Hemoglobin level. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement: Hemiglobincyanide(HiCN) method. Serum Creatinine level. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement: Jaffe method. Serum phosohorus level. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement: Colorimetric method. Serum Calcium Level. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement: Colorimetric method. Blood Urea nitrogen. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement: Enzymatic method. Cholesterol level. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement: Enzymaticl method. Triglyceride level. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement: Enzymatic method. Serum Ferritin level. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement: ELISA Kit. Serum Iron level. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement: Colorimetric method. Parathyroid Hormone level. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement:  Immunoassay (Analytical methods ). C_Reactive protein level. Timepoint: Immediately before the intervention, in the second month of intervention, after the intervention. Method of measurement: Latex agglutination method. Tabriz University of Medical Sciences Approved 2016-10-10 Ethics Committee of Tabriz University of Medical Sciences No 2 Central Building , Tabriz University of Medical Sciences , Golgasht Street , Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)