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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.
Montelukast is an antileukotrien receptor antagonist that seems to be effective as an antipruritic medication via blocking inflammatory pathways.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| montelukast | Active Comparator | montelukast 10 milligram, daily for 30 days |
|
| placebo | Placebo Comparator | Placebo one tablet for 30 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Detailed score proposed by Duo for pruritus | Change from Baseline in Detailed score at 1months | Change from Baseline in Detailed score at 1months |
| Measure | Description | Time Frame |
|---|---|---|
| Highly sensitive CRP (hs-CRP) | This test is a serologic biochemical test | Change from Baseline in serum value at 1months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohammad Mehdi Sagheb, Professor | Shiraz University of Medical Sciences | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33283264 | Derived | Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 25, 2015 | |
| Reset | Oct 22, 2015 | |
| Release | Oct 23, 2015 | |
| Reset | Nov 27, 2015 | |
| Release | Dec 14, 2015 | |
| Reset | Jan 15, 2016 | |
| Release | Jan 18, 2016 | |
| Reset | Feb 16, 2016 | |
| Release | Apr 19, 2016 | |
| Reset | May 20, 2016 | |
| Release | Apr 17, 2019 | |
| Reset | May 7, 2019 | |
| Release | May 7, 2019 | |
| Reset | May 28, 2019 | |
| Release | Aug 11, 2020 | |
| Reset | Aug 20, 2020 | |
| Release | Aug 21, 2020 | |
| Reset | Sep 11, 2020 | |
| Release | Sep 16, 2020 | |
| Reset | Oct 8, 2020 | |
| Release | Oct 30, 2020 | |
| Reset | Nov 24, 2020 | |
| Release | Nov 24, 2020 | |
| Reset | Dec 18, 2020 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 25, 2015 | Oct 22, 2015 | |||
| Oct 23, 2015 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C093875 | montelukast |
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Placebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills |
|
| Nov 27, 2015 |
| Dec 14, 2015 | Jan 15, 2016 |
| Jan 18, 2016 | Feb 16, 2016 |
| Apr 19, 2016 | May 20, 2016 |
| Apr 17, 2019 | May 7, 2019 |
| May 7, 2019 | May 28, 2019 |
| Aug 11, 2020 | Aug 20, 2020 |
| Aug 21, 2020 | Sep 11, 2020 |
| Sep 16, 2020 | Oct 8, 2020 |
| Oct 30, 2020 | Nov 24, 2020 |
| Nov 24, 2020 | Dec 18, 2020 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |