Pruritus is the most distressing symptom in haemodialysis patients. Its aetiology has not yet been delineated, and thus there are no good therapeutical options. Serotonin has been reported to be a mediator of uremic pruritus, and ondansetron is a potent and selective inhibitor of 5-HT3 receptors. The aim of our study was to evaluate the effect of ondansetron on uremic pruritus in haemodialysis patients. All patients undergoing haemodialysis at the dialysis unit in Valiasr Hospital were asked to complete a questionnaire about pruritus .Pruritus scores were distinguished by a visual analogue scale (VAS) system between 0 and 10 and recorded for 2 weeks twice a day (morning and evening). Patients with pruritus score more than 4 were considered for inclusion. Criteria for exclusion of patients from the study included age less than 18 years, patients with a history of skin or metabolic disease causing itching, patients who received ani-pruritic medications two weeks before, pregnant women and non-cooperation patients. The final analysis included 70 patients. They were randomly divided into two groups: one group, ondansetron 8 mg three times daily and the other group was given loratadine (placebo) 10 mg two times a day for 2 week and pruritus scores were recorded by the patients. The mean scores were compared before and after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201111288241N1
Registration date:2013-02-21, 1391/12/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-21, 1391/12/03
Registrant information
Name
Mina Mirnezami
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1224 1411
Email address
dr.mirnezami@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research and education of Arak University of Medical Sciences
Expected recruitment start date
2010-09-23, 1389/07/01
Expected recruitment end date
2010-11-21, 1389/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of ondansetron and placebo on pruritus in hemodialysis patients
Public title
Effect of ondansetron on pruritus in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with chronic renal failure undergoing hemodialysis; willingness of patients for entry into the study; minimum age 18 years. Exclusion criteria: Patients with a history of skin or metabolic disease causing itching; Patients who received anti-pruritic medications two weeks before; pregnant women; People under age 18; non-cooperation Patients.
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
University of Medical sciences٬ Arak
City
Arak
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
89-81-7
Health conditions studied
1
Description of health condition studied
Chronic renal failure
ICD-10 code
N17-N19
ICD-10 code description
Renal failure
Primary outcomes
1
Description
Pruritus
Timepoint
Baseline - A week later, two weeks after the intervention.
Method of measurement
VAS
Secondary outcomes
1
Description
Side effect
Timepoint
During the intervention
Method of measurement
Visual and laboratory
Intervention groups
1
Description
Ondansetron tablets 8 mg three times daily for two weeks in the intervention group
Category
Treatment - Drugs
2
Description
Loratadine tablets 10 mg twice daily in the control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Medical Center Hemodialysis Unit, Arak
Full name of responsible person
Dr. Mina Mirnezami
Street address
Valiasr Hospital
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research and education
Full name of responsible person
Dr. Changizi Ashtiani
Street address
Vice chancellor for research and education, Basij Square
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research and education
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
Arak University of Medical Sciences
Full name of responsible person
Dr. Mina Mirnezami
Position
Diploma of Dermatology/Assistant Professore
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
Phone
+98 86 1224 1411
Fax
Email
mirnezamim@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mina Mirnezami
Position
Diploma of Dermatology/Assistant Professore
Other areas of specialty/work
Street address
Valiasr Hospital
City
Arak
Postal code
Phone
+98 86 1224 1411
Fax
Email
mirnezamim@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Mina Mirnezami
Position
Diploma of Dermatology/Assistant Professore
Other areas of specialty/work
Street address
Valiasr Hospital٬ Arak
City
Arak
Postal code
Phone
+98 86 1224 1411
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)