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IRCT20190107042264N3 IRCT 2020-12-16 Ahvaz University of Medical Sciences The effect of pentoxifylline on diabetic microalbuminuria Determination of the effect of pentoxifylline on microalbuminuria in type 2 diabetic patients 2020-11-21 anticipated 58 Complete https://irct.ir/trial/52638 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using a Sequence Generator (freely available at www.random.org), A set of numbers from 1 to 58 was requested in two columns, the results were two columns of 29 Integers from one to 58, without repetition, which were used for division, Blinding description: After obtaining a series of unsorted random numbers from the website, this series of numbers is provided to the pharmacist by the statistical consultant to code the drugs. The pharmacist then sorts the drug and placebo in encoded packages. After the eligible patients are referred, the drugs are given to them in the order of referral. Patients, prescribing physicians, and data collectors are kept blind to the contents of the drug. 3 Albuminuria in patients with diabetes Mellitus type II. Intervention 1: Intervention group: Patients in this group, in addition to receiving treatment for the underlying disease that is not altered by the intervention, are treated with pentoxifylline 400 mg (Farabi Company; Iran) once a day, after meals. This treatment lasts for 12 weeks. Intervention 2: Control group: Patients in this group, in addition to receiving treatment for the underlying disease that is not altered by the intervention, are treated with placebo (produced in the Faculty of Pharmacy of Ahvaz Jundishapur University) once a day, after meals. This treatment lasts for 12 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Shokouh Shayanpour
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3222 2114 shayanpour-sh@ajums.ac.ir Ahvaz University of Medical Sciences scientific Shokouh Shayanpour
Imam Khomeini Hospital - Shahid Ahvazian Street - Azadegan Street
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3222 2114 shayanpour-sh@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Type II Diabetic Patients Proteinuria more than 150mg/24hours Microalbuminuria of more than 20 mg albumin excretion in 24 hour urine 18 years 80 years Both Patients Suffering from Diabetic Retinopathy Hypersensitivity to pentoxifylline Pregnancy Heart failure with Ejection fraction less than 35% Any acute or febrile illness one month before induction to study Use of spironolactone Use of Warfarin E08.2 Diabetes mellitus due to underlying condition with kidney complications Treatment - Drugs Placebo Intervention group: Patients in this group, in addition to receiving treatment for the underlying disease that is not altered by the intervention, are treated with pentoxifylline 400 mg (Farabi Company; Iran) once a day, after meals. This treatment lasts for 12 weeks. Control group: Patients in this group, in addition to receiving treatment for the underlying disease that is not altered by the intervention, are treated with placebo (produced in the Faculty of Pharmacy of Ahvaz Jundishapur University) once a day, after meals. This treatment lasts for 12 weeks. Albuminuria. Timepoint: before intervention, 12 weeks after intervention. Method of measurement: 24-hour urine collection. Ahvaz University of Medical Sciences Approved 2020-11-04 Ethics committee of Ahvaz Jundishapur University of Medical Sciences Faculty of Medicine, Ahvaz Jundishapur University of Medical Sciences, Esfand Street, Golestan, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)