Montelukast for Treatment of Uremic Pruritus
NCT02559388 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 73
Last updated 2015-09-24
Summary
In this study hemodialysis patients that underwent dialysis thrice weekly screen for uremic pruritus and 80 patients that at least have refractive pruritus that lead to sleep and daily activity disorders enroll in this study. These patients should have at least a course of therapy without proper response. After proper informing patients and taking testimonial patients enter to study. Then patients randomized in case and control group. In case group, patients took montelukast 10 milligram daily and in control group took placebo for 30 days. Other antipruritic or antiinflammatory medication has been stopped one week prior to starting treatment. Calcium, phosphorous, urea, creatinine, highly sensitive CRP (hsCRP), Parathyroid Hormone (PTH), hemoglobin and kt/V were measured at beginning and at end of study. pruritus severity assessed by Detailed Pruritus Score that introduced by Duo and Visual Analogue Score in beginning and at end of study in both group. Sleep disorder score and its severity added to crude score at beginning and end of study and change of measures analyzed.
Conditions
- Renal Insufficiency, Chronic
Interventions
- DRUG
-
Montelukast
- DRUG
-
Placebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills
Sponsors & Collaborators
-
Shiraz University of Medical Sciences
lead OTHER
Principal Investigators
-
Mohammad Mehdi Sagheb, Professor · Shiraz University of Medical Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-04-30
- Primary Completion
- 2015-08-31
- Completion
- 2015-08-31
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