Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Pruritus is a major disorder among the skin derangements in advanced renal failure. Recent information suggests that interactions between dermal mast cells and distal ends of nonmyelinated C fibers may be important in the precipitation and regulation of the sensory stimuli.Patients having uremic pruritus have been noted to have increased levels of plasma histamine and tryptase as well as increased numbers of dermal mast cells.Cromolyn sodium is a mast cell stabilizing agent that inhibits degranulation of mast cells and the release of histamine, tryptase, and leukotrienes. It is hypothesized that oral cromolyn sodium may attenuate uremic pruritus by decreasing serum tryptase level.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Patients on hemodialysis with pruritus, receiving cromolyn sodium |
|
| 2 | Experimental | patients on hemodialysis with pruritus, receiving placebo |
|
| 3 | No Intervention | Patients on hemodialysis but without pruritus who do not receive any treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cromolyn sodium | Drug | oral cromolyn sodium, capsule 135mg, 1 capsule 3 times daily for 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| pruritus | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| serum tryptase level | 4 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ghazal Vessal, PharmD, BCPS | Shiraz University of Medical Sciences | Study Director |
| Mohammad Mahdi Sagheb, MD | Shiraz University of Medical Sciences | Principal Investigator |
| Saman Shilian, Pharm student | Shiraz University of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shiraz University of Medical sciences, Nemazi and Faghihi Hospital | Shiraz | Fars | 71345 | Iran |
| 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. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Dec 17, 2012 | |
| Reset | Jan 22, 2013 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 17, 2012 | Jan 22, 2013 |
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004205 | Cromolyn Sodium |
| ID | Term |
|---|---|
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
capsule contains 135 mg lactose, 1 capsule 3 times daily for 8 weeks |
|
| D052776 |
| Female Urogenital Diseases |
| 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 |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |