Pruritus is a major disorder among the skin derangements in advanced renal failure. 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.In this study we include 20 dialysis patients without pruritus as a negative control. Sixty 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 will be included. A baseline blood sample will be taken to determine the plasma levels of tryptase. A baseline level of pruritus will also be determined for the 60 patients who were suffering from pruritus using the Visual Analogue scale (VAS). The 60 patients with pruritus are randomely assigned into 2 groups, and the study is double blind. Patients receive oral cromolyn sodium or placebo, 135mg, 3 times daily for 8 weeks.
The level of pruritus will be determined 3 times a week during the whole study period. A second blood sample will be taken after 8 weeks to determine tryptase level.Next, the drug or placebo will be discontinued and the tryptase level rechecked after 4 weeks. All blood samples will be frozen at -70 C and sent to Tehran Asthma and Allergy center for tryptase determination via UNICAP.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138710291562N1
Registration date:2009-06-23, 1388/04/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2009-06-23, 1388/04/02
Registrant information
Name
Ghazal Vessal
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1242 4127
Email address
gvessal@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of medical Sciences
Expected recruitment start date
2008-08-04, 1387/05/14
Expected recruitment end date
2009-01-04, 1387/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
Public title
Evaluating the Effect of Cromolyn Sodium in Uremic Pruritus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
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
Exclusion Criteria:
Known dermatologic, liver, metabolic disease, or any other disease or condition other than ESRD that causes pruritus
consumption of antihistamines or other antipruritic drugs
Lactase deficiency
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
clinicaltrials.gov
Secondary trial Id
NCT00745199
Registration date
2008-09-02, 1387/06/12
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand street- central building of Shiraz University of Medical Sciences, seventh floor
City
Shiraz
Postal code
71345
Approval date
2008-08-04, 1387/05/14
Ethics committee reference number
4146-87-ct
Health conditions studied
1
Description of health condition studied
pruritus in dialysis patients
ICD-10 code
N28
ICD-10 code description
Other disorders of kidney and ureter, not elsewhere classified
Primary outcomes
1
Description
pruritus
Timepoint
3 times a week up to 8 weeks
Method of measurement
VAS
Secondary outcomes
1
Description
tryptase serum level
Timepoint
8 weeks
Method of measurement
UNICAP
Intervention groups
1
Description
cromolyn sodium 135 mg TID for 8 weeks
Category
Treatment - Drugs
2
Description
placebo in control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nemazi Hospital
Full name of responsible person
Street address
City
Shiraz
2
Recruitment center
Name of recruitment center
Shahid Faghihi Hospital
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of medical sciences
Full name of responsible person
Dr Mohammad Hossein Dabbaghmanesh
Street address
Vice chancellor for research, Shiraz University of medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
4146
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shiraz University of medical Sciences
Full name of responsible person
Dr.Ghazal Vessal
Position
Assistant prof
Other areas of specialty/work
Street address
Faculty of Pharmacy, Shiraz University of medical Sciences
City
Shiraz
Postal code
71345
Phone
+98 71 1242 4127
Fax
Email
gvessal@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Pharmacy, Shiraz University of medical Sciences
Full name of responsible person
Dr.Ghazal Vessal
Position
Assistant prof
Other areas of specialty/work
Street address
Faculty of Pharmacy, Shiraz University of medical Sciences
City
Shiraz
Postal code
71345
Phone
+98 71 1242 4127
Fax
Email
gvessal@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of Pharmacy, Shiraz University of medical Sciences
Full name of responsible person
Dr.Ghazal Vessal
Position
assistant prof
Other areas of specialty/work
Street address
Faculty of Pharmacy, Shiraz University of medical Sciences
City
Shiraz
Postal code
71345
Phone
+98 71 1242 4127
Fax
Email
gvessal@sums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)