]>
IRCT20190806044451N2 IRCT 2021-01-09 Zanjan University of Medical Sciences Efficacy of Pentoxifylline in diabetic nephropathy Evaluation of the effects of combination therapy of pentoxifylline and losartan in comparison with losartan alone on diabetic nephropathy 2019-07-13 anticipated 60 Complete https://irct.ir/trial/41582 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method in this study is simple randomization and the randomization unit is also individual. Subjects in this study will be divided into control (losartan treatment) and intervention (losartan treatment with pentoxifylline) groups using coin throwing (coin toss) method, Blinding description: This study is single blind and the patient will be explained about the cause of administration and the effect and side effects of the prescribed drug. The two groups will not be in relationship with each other and the the name of pentoxifylline will not be said to the control group. 3 Condition 1: Type 2 Diabetes. Condition 2: Diabetic Nephropathy. Intervention 1: Intervention group: Add oral Pentoxifylline 400 mg (twice daily) to oral Losartan 50 mg (twice daily) for 3 months. Intervention 2: Control group: Continue treatment with oral Losartan 50 mg twice daily for 3 months. Yes - There is a plan to make this available What will be shared: All potential data can be shared after making people unidentifiable When: Start access period 3 months after publishing the results To whom: It will only be available to researchers working in academic and scientific institutions Conditions: With the written and official permission of the researcher or supervisor, access to all documents will be possible Where to obtain: Contact those in charge through these numbers 09146592655- 02433770758. Email: somayehjalali10@yahoo.com. Corresponding Address: Metabolic Disorders Research Center, Valiasr Hospital, Zanjan, Iran How to obtain: 1) Contact the person in charge or the researcher and coordinate. 2) Submit request by email or letter. This may take at least a month to access the data. Comments:
public Somayeh Jalali
Metabolic diseases researchs center ,Valiasr hospital, Shariati blvd, Zanjan
Zanjan Iran (Islamic Republic of) 4515777978 +98 24 3377 0758 somayehjalali10@yahoo.com Zanjan University of Medical Sciences scientific Somayeh Jalali
Metabolic diseases research center, Valiasr Hospital, Shariati blvd.
zanjan Iran (Islamic Republic of) 4515777978 +98 24 3377 0758 somayehjalali10@yahoo.com Zanjan University of Medical Sciences Iran (Islamic Republic of) Type 2 diabetic patients treated with insulin and oral agents GFR above 30 cc / min / 1.73 m2 albuminuria above 300 mg/g no limit no limit Both Patient dissatisfaction Type 1 diabetes Pentoxifylline allergy Chronic heart failure Uncontrolled hypertension Other medicines that affect albuminuria Cerebral hemorrhage Extensive retinal hemorrhage ESRD, GFR <30 Pregnancy Hyperkalemia (high potassium) 5.5 before or during the study) E11 N00-N08 Type 2 diabetes mellitus بیماریهای گلومرولی Treatment - Drugs Treatment - Drugs Intervention group: Add oral Pentoxifylline 400 mg (twice daily) to oral Losartan 50 mg (twice daily) for 3 months. Control group: Continue treatment with oral Losartan 50 mg twice daily for 3 months Random Urin Albumin/Creatinine. Timepoint: 3 months before intervention and before starting pentoxifylline and 3 months after starting pentoxifylline. Method of measurement: Lab test. Creatinin. Timepoint: Before starting pentoxifylline and 3 months after starting pentoxifylline. Method of measurement: Lab test. Hemoglobin A1c. Timepoint: Before starting pentoxifylline and 3 months after starting pentoxifylline. Method of measurement: Lab test. Blood pressure. Timepoint: Before starting pentoxifylline and 3 months after starting pentoxifylline. Method of measurement: Sphygmomanometer. Body mass index. Timepoint: Before starting pentoxifylline and 3 months after starting pentoxifylline. Method of measurement: meter & Balance. Fasting blood sugar (FBS). Timepoint: Before starting pentoxifylline and 3 months after starting pentoxifylline. Method of measurement: Lab test. Pentoxifylline Complications. Timepoint: Before starting pentoxifylline and 3 months after starting pentoxifylline. Method of measurement: History taking. Zanjan University of Medical Sciences Approved 2019-07-13 Ethics Committee of Zanjan University of Medical Sciences Metabolic dieases research center, Vali-e-asr hospital, Sheikh Fazlollah street Zanjan Zanjan Iran (Islamic Republic of)