Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
- Conditions
- PruritusEnd Stage Renal Disease
- Interventions
- Drug: placebo
- Registration Number
- NCT00745199
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- Hemodialysis patients > 18 yo suffering from pruritus for at least 6 weeks, and who have not responded to other drugs
- Willing and able to give informed concent
- Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
- Lactase deficiency
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 placebo patients on hemodialysis with pruritus, receiving placebo 1 cromolyn sodium Patients on hemodialysis with pruritus, receiving cromolyn sodium
- Primary Outcome Measures
Name Time Method pruritus 3 months
- Secondary Outcome Measures
Name Time Method serum tryptase level 4 months
Trial Locations
- Locations (1)
Shiraz University of Medical sciences, Nemazi and Faghihi Hospital
🇮🇷Shiraz, Fars, Iran, Islamic Republic of