Comparison of the efficacy and safety of mirtazapine and hydroxyzine in the treatment of uremic pruritus in hemodialysis patients: A randomized, double-blind controlled clinical trial

Mazandaran University of Medical Sciences0 个研究点目标入组 60 人开始时间: 待定最近更新: 2024年3月6日

适应症

试验速览

暂无简介。

•Age older than 18 years
•Hemodialysis for at least 3 months and having itch despite the adequacy of hemodialysis (Kt/V > 1.2)
•5D-itch score more than 5
•PSQI score equal and above 5

•Anemia ( Hemoglobin less than 7 g/dL)
•Hyperparathyroidism ( iPTH > 600 )
•Phosphorus level higher than 6 mg/dL and calcium higher than 10.5 mg/dL, or calcium multiplied by phosphorus higher than 60
•Chronic skin diseases with itching which not related to uremia caused by kidney failure, such as psoriasis, dermatitis, and lichen planus.
•Chronic liver failure or high bilirubin level (1.5 times higher than the upper limit of normal) , and ALT, AST more than 5 times higher than the upper limit of normal.
•Untreated hypothyroidism
•Patients with psychiatric disorders, such as bipolar disorder, mental retardation, cognitive-functional disorder, or use of any psychotropic medication during the past month.
•History of suicide or patients with suicidal ideation
•Inability to receive oral medication
•Use of corticosteroids and opium
•Pregnancy and lactation
•History of allergy to mirtazapine
•Receiving medications that used for sleep disorders treatment within 1 month before entering the study (such as tricyclic antidepressants, atypical antidepressants, benzodiazepines, antihistamines, anticholinergics, and barbiturates)
•No interest to participate in the study or continue to treatment
•Any complications leading to intolerance and discontinuation of treatment with studied drugs

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