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IRCT20160920029889N1 IRCT 2018-01-09 Oroumia University of Medical Sciences Evaluation of allopurinol efficacy in patients with nonalcoholic fatty liver disease Evaluation of allopurinol efficacy in patients with nonalcoholic fatty liver disease: a randomized, double blind, placebo-controlled trial 2018-01-21 anticipated 44 Complete https://irct.ir/trial/27877 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The blocked randomization method; online; by creating the random blocks of 4 and 6 subjects and unique randomization codes; by the person who does not play a role in intervention and checking inclusion criteria, Blinding description: A person who is not involved in intervention and is unaware of the randomization and allocation of patients, packs medications based on randomization codes.Drugs are delivered to the patients according to the codes. Participants, health care personnel, researcher, evaluators of the outcome and data analyzer are blind. This blindness remains hidden until statistical analysis completes. 3 nonalcoholic fatty liver disease. Intervention 1: Intervention group: reception of allopurinol 300 mg (manufacturing Ramopharmin Pharmaceutical Company) once a day, for 4 months. Intervention 2: Control group: reception of placebo (manufacturing faculty of pharmacy) once a day, for 4 months. Yes - There is a plan to make this available What will be shared: Individual participant data - All data is shared. Study protocol- The entire protocol is shared. Statistical analysis scheme- The whole scheme is shared. Consent Form Conscious- All parts of the form are shared. Clinical study report- All clinical reports are shared. When: Start the access period: 8 months after printing results- Access time interval: Unlimited To whom: Researchers working in academic and scientific institutions Conditions: To conduct systematic review and meta-analysis Where to obtain: 1- Dr. Afshin Shiva, shiva@umsu.ac.ir 2- Dr. Sepideh Ahadi, sepidehahadi21@ymail.com How to obtain: The data will be available 8 months after the results are printed. The applicant can receive data by emailing the request in less than one month. Comments:
public Afshin Shiva
Department of Clinical Pharmacy, Faculty of Pharmacy, Pardis Nazlou, 11 km of Nazlou Road, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3275 4991 shiva@umsu.ac.ir Oroumia University of Medical Sciences scientific Afshin Shiva
Department of Clinical Pharmacy, Faculty of Pharmacy, Pardis Nazlou, 11 km of Nazlou Road, Urmia
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3275 4991 shiva@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 18 and 70 years Not having history of alcohol consumption Lack of other liver diseases The levels of aminotransferases should not exceed 2.5 times the upper limit of normal No previous allergy to allopurinol Not having chronic kidney disease (definedas an estimated glomerular filtration rate <60 mL/min/1.73m2) Serum uric acid levels greater than 4 mg/dl for men and more than 3 mg/dl for women For diabetic patients, hemoglobin A1c should be less than 8% and the dose of antidiabetic drugs should be constant for at least 3 months Not having hematological disorders Not having kidney stones 18 years 70 years Both Pregnancy and lactation Use of drugs interact with allopurinol (including didanosine, angiotensin-converting enzyme inhibitors, antacids (except sodium bicarbonate), azathioprine, mercaptopurine, vitamin K antagonists (including warfarin and other coumarin derivatives)) Taking hepatotoxic drugs (including calcium channel blockers, high doses of synthetic estrogens, methotrexate, amiodarone, chloroquine) Occurrence of allergic reaction due to allopurinol intake K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Drugs Placebo Intervention group: reception of allopurinol 300 mg (manufacturing Ramopharmin Pharmaceutical Company) once a day, for 4 months Control group: reception of placebo (manufacturing faculty of pharmacy) once a day, for 4 months Change in liver steatosis. Timepoint: before the intervention and at the end of the study. Method of measurement: abdominal computed tomography scans-no contrast injection-spiral (liver hounsfield unit and the liver attenuation index (liver hounsfield unit minus spleen hounsfield unit)). Change in systemic inflammation. Timepoint: before the intervention and at the end of the study. Method of measurement: high sensitivity c-reactive protein. Change in insulin resistance. Timepoint: before the intervention and at the end of the study. Method of measurement: homeostasis model assessment of insulin resistance. Change in oxidative stress. Timepoint: before the intervention and at the end of the study. Method of measurement: malondialdehyde. Change in lipid profile. Timepoint: before the intervention and at the end of the study. Method of measurement: triglycerides, total cholesterol, high density lipoprotein, low density lipoprotein. Change in liver enzymes. Timepoint: before the intervention and at the end of the study. Method of measurement: alanine aminotransferase, aspartate aminotransferase. Change in anthropometric measurements. Timepoint: before the intervention and at the end of the study. Method of measurement: weight, body mass index, waist circumference, hip circumference, waist to hip ratio. Oroumia University of Medical Sciences Approved 2017-02-08 Ethics committee of Urmia University of Medical Sciences Urmia University of Medical Sciences, Orjhans Street, Resalat Blvd, Urmia Urmia West Azarbaijan Iran (Islamic Republic of)