IRCT20120314009297N9
Recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- remic pruritus.
- Sponsor
- Mazandaran University of Medical Sciences
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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