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IRCT2015060922637N1 IRCT 2015-08-29 Kerman University of Medical Sciences Comparison of pregabalin with doxepin in the management of uremic pruritus Comparison of pregabalin with doxepin in the management of uremic pruritus 2015-05-31 anticipated 70 Complete https://irct.ir/trial/19490 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2-3 ESRD. Intervention 1: Pregabalin (Oral Capsule 50 mg): The initial dose of pregabalin is 50 mg three times a week (after each dialysis session in hemodialysis patients). After one week, if response to the medication is not satisfactory, dose will be increased to 50 mg per day. ِDuration of the study is 4 weeks. Intervention 2: Doxepin (Oral Capsule 10 mg): The initial dose of doxepin is 10 mg per day. After 1 week, if response to the medication is not satisfactory, dose of the drug will be increased to 10 mg two times per day. Duration of the study is four weeks.
public Naemeh Nikvarz
Faculty of pharmacy, Haft-Bagh Boulevard
Kerman Iran (Islamic Republic of) 7616911319 +98 34 3121 5017 nnikvarz@kmu.ac.ir Kerman University of Medical Sciences scientific Naemeh Nikvarz
Faculty of pharmacy, Haft-Bagh Boulevard
Kerman Iran (Islamic Republic of) 7616911319 +98 34 3121 5017 nnikvarz@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: age between 16-80 years old; undergoing regular hemodialysis or peritoneal dialysis Exclusion criteria: history of allergy to pregabalin or doxepin; liver failure; pregnancy; history of epilepsy or a single episode of seizure; uncontrolled psychiatric illness; decompensated heart failure; narrow angle glaucoma; hyperthyroidism; history of myocardial infarction in the past three months; heart block; low blood pressure(Systolic blood pressure less than 90 mmHg) 16 years 80 years Both N 18.5 End stage kidney disease on dialysis Treatment - Drugs Treatment - Drugs Pregabalin (Oral Capsule 50 mg): The initial dose of pregabalin is 50 mg three times a week (after each dialysis session in hemodialysis patients). After one week, if response to the medication is not satisfactory, dose will be increased to 50 mg per day. ِDuration of the study is 4 weeks. Doxepin (Oral Capsule 10 mg): The initial dose of doxepin is 10 mg per day. After 1 week, if response to the medication is not satisfactory, dose of the drug will be increased to 10 mg two times per day. Duration of the study is four weeks. Severity of pruritus. Timepoint: Before the intervention, and one week, two weeks and four weeks after the intervention. Method of measurement: Visual Analogue Scale. Severity of pruritus and its impact on the quality of life. Timepoint: Before the intervention, and one week, two weeks and four weeks after the intervention. Method of measurement: 5-D itch scale. Effect of pruritus on the quality of life. Timepoint: Before the intervention and one week, two weeks and four weeks after the intervention. Method of measurement: Dermatology Life Quality Index (DLQI). Adverse effects. Timepoint: At the end of the first and fourth weeks of the intervention. Method of measurement: Checklist of adverse effects. Kerman University of Medical Sciences Approved 2015-05-30 Ethics committee of Kerman University of Medical Sciences Research assistance office of Kerman University of Medical Sciences, Ebne-Sina street Kerman Iran (Islamic Republic of)