The aim of this study was to compare the effect of zinc sulfat and Hydroxyzine in the treatment of pruritus in hemodialysis patients is ongoing. The study is double-blind clinical trial patients who consent to participate in the trial and that they have at least three months of hemodialysis and other anti-itch medication received and not sensitive to zinc sulfate and hydroxyapatite saddle and in the study has been kidney transplantation, Cherubis and increased alkaline phosphatase or intolerance to either of these two drugs are excluded. During a three-month study of 50 patients in the group with zinc sulfate tablets 220 mg of zinc daily (one tablet first month, two tablets in second month and three tablets in third month) and 50 patients in the control group, with hydroxyzine tablets 25 mg daily (one tablet first month, two tablets in second month and three tablets in third month) receive. Itching in 15 days to three months before and after the test was measured by VAS and compared together.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411252954N5
Registration date:2015-11-26, 1394/09/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-26, 1394/09/05
Registrant information
Name
Mohammad Bagher Sohrabi
Name of organization / entity
Shahroud University of Medical Ssciences and Health
Country
Iran (Islamic Republic of)
Phone
+98 23 3239 5054
Email address
mb.sohrabi@shmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahroud University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-04-18, 1395/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Zinc sulfate and Hydroxyzine on pruritus of hemodialysis patients , a double blind randomized control trial
Public title
Evaluation effects of Zinc sulfate and Hydroxyzine in pruritus treatment of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic pruritus refractory to other treatments over 4 weeks. In the last 2 weeks in 1 month moisturizing cream and antihistamines to relieve itching liver. Patients have not used.
Exclusion criteria: drug intolerance - a kidney transplant before the end of the study - Hyperparathyroidism - increased ALK, sensitivity to any of the above medications, Patient dissatisfaction
Age
From 15 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahroud University of Medical Sciences
Street address
Shahroud University of Medical Sciences,7 Tir squer, Shahroud
City
Shahroud
Postal code
3616647555
Approval date
2015-09-07, 1394/06/16
Ethics committee reference number
IR.SHMU.REC.1394.73
Health conditions studied
1
Description of health condition studied
Pruritus of Hemodialysis patients
ICD-10 code
N18.0
ICD-10 code description
End-stage renal disease
Primary outcomes
1
Description
Severity Pruritus
Timepoint
Twice a weeks
Method of measurement
Visual Analog Scor(VAS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group (Group I) will receive Zinc sulfate. Zinc sulfate will be started as 220 mg/day for the firth month,440mg/day for second month and 660 mg/day for third month . pruritus will be checked every two week . Zinc sulfate will continue till 12 weeks.
Category
Treatment - Drugs
2
Description
Control group (Group II) will receive Hydroxyzine. Hydroxyzine will be started as 25 mg/day for the firth month,50 mg/day for second month and 75 mg/day for third month . pruritus will be checked every two week . Hydroxyzine will continue till 12 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hossein hospital of Shahroud
Full name of responsible person
Dr.Monireh Amerian
Street address
Imam Hossein hospital, End Imam street , Shahroud , Iran
City
Shahroud
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Shahroud University medical and Sciences
Full name of responsible person
Dr. Mohammad Hasan Imamian
Street address
Vice chancellor for research, Shahroud University medical Sciences ,7th Tir squar, Shahroud
City
Shahroud
Grant name
بودجه پژوهشی
Grant code / Reference number
9423
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Shahroud University medical and 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
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General practitioner
Other areas of specialty/work
Street address
Imam Hossein hospital , End Imam street, Shahroun , Iran
City
Shahroud
Postal code
3616647555
Phone
+98 23 3239 5054
Fax
+98 23 3239 4800
Email
mb.sohrabi@yahoo.com ,mb.sohrabi@shmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahroud University of Medical Sciences
Full name of responsible person
Dr.Monireh Amerian
Position
Nephrologist
Other areas of specialty/work
Street address
Imam Hossein hospital , End Imam street, Shahroun , Iran
City
Shahroud
Postal code
3616611151
Phone
+98 23 3234 2000
Fax
+98 23 3233 3902
Email
amerian1060@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahroud University of Medical science
Full name of responsible person
Dr.Mohammad Bagher Sohrabi
Position
General Practitioner
Other areas of specialty/work
Street address
Imam Hossein hospital, End Imam street, Shahroud,Iran
City
Shahroud
Postal code
3616647555
Phone
+98 23 3239 5054
Fax
+98 23 3239 4800
Email
mb.sohrabi@yahoo.com ,mb.sohrabi@shmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)