The objective of this randomized, double-blind clinical trial is evaluation of the effect of Gabapentin and Hydroxyzine in pruritus of dialysis patients.
Design
In this study, 30 dialysis patients with pruritus will be assigned into the study randomly and the subjects will be divided into two groups A and B randomly. Inclusion criteria of the study are dialysis patients and pruritus. Exclusion criteria of the study are Severe dry skin; Scabies; Psoriasis; Skin lymphoma; Liver cholestasis; Neurological patients and Psychologic patients.
Settings and conduct
In this randomized, double-blind clinical trial, 30 dialysis patients with pruritus will be assigned into the study randomly and the subjects will be divided into two groups A and B randomly. The Pruritus Scale questionnaire will be used to measure the Pruritus. Tablet Gabapentin 100mg oral, once in a day will be administered for six weeks for group (A) and Tablet Hydroxyzine 25mg oral, once in a day will be administered for six weeks for group (B). Patients will be evaluated after six weeks. Patients will not receive drugs for two weeks for pruritus. Then Tablet Gabapentin 100mg oral, once in a day will be administered for six weeks for group (B) and Tablet Hydroxyzine 25mg oral, once in a day will be administered for six weeks for group (A). Patients will be evaluated after six weeks again. Finally the collected data will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria of the study are dialysis patients and pruritus. Exclusion criteria of the study are Severe dry skin; Scabies; Psoriasis; Skin lymphoma; Liver cholestasis; Neurological patients and Psychologic patients.
Intervention groups
Tablet Gabapentin 100mg oral, once in a day will be administered for six weeks for group (A) and Tablet Hydroxyzine 25mg oral, once in a day will be administered for six weeks for group (B).
Main outcome variables
The Pruritus Scale questionnaire will be used to measure the Pruritus at the beginning of the first intervention, 6 weeks after the first intervention, at the beginning of the second intervention and 6 weeks after the second intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160318027097N7
Registration date:2017-12-13, 1396/09/22
Registration timing:prospective
Last update:2017-12-13, 1396/09/22
Update count:0
Registration date
2017-12-13, 1396/09/22
Registrant information
Name
ِDr Faramarz Darghahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3351 2000
Email address
mj.naghizadeh@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2018-04-21, 1397/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of Gabapentin and Hydroxyzine in pruritus in dialysis patients
Public title
Effect of Gabapentin and Hydroxyzine in pruritus of dialysis patients
The randomization is block, individual and using a random number table in this study. 30 numbers will entered the random block and numbers are randomly assigned into two groups. Accordingly, the patients will receive one of two regimens with their randomly assigned number. In this study, participants, researchers are unaware of prescription drugs.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, participants, researchers are unaware of prescription drugs.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ardebil University of Medical Sciences
Street address
Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil , Ardabil , Iran
City
Ardebil
Province
Ardabil
Postal code
5163639888
Approval date
2017-10-23, 1396/08/01
Ethics committee reference number
IR.ARUMS.REC.1396.132
Health conditions studied
1
Description of health condition studied
Pruritus
ICD-10 code
L29
ICD-10 code description
Pruritus
Primary outcomes
1
Description
Pruritus
Timepoint
At the beginning of the first intervention, 6 weeks after the first intervention, at the beginning of the second intervention and 6 weeks after the second intervention.
Method of measurement
Pruritus Scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Tablet Gabapentin 100mg oral, once in a day for 6 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Tablet Hydroxyzine 25mg oral, once in a day for 6 weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Boali hospital
Full name of responsible person
Dr Mohammad Ghorghani
Street address
Boali hospital, Daneshgah Avenue, Ardebil, Iran
City
Ardebil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Email
naghizadeh73@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Afshan Sharghi
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Email
A.sharghi@arums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Mohammad Ghorghani
Position
دانشجو دستیاری داخلی
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil , Ardabil , Iran
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Email
naghizadeh73@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Sosan Mohammadi Kebar
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Ardebil University of Medical Sciences, Daneshgah Avenue, Ardebil, Iran
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2006
Email
S.mohammadikebar@arums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr Mohammad Ghorghani
Position
Internal Medicine Assistant
Latest degree
Medical doctor
Other areas of specialty/work
Internal Medicine
Street address
Ardabil University of Medical Sciences, Daneshgah Avenue, Ardabil , Ardabil , Iran
City
Ardabil
Province
Ardabil
Postal code
5163639888
Phone
+98 45 3351 2000
Email
naghizadeh73@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Total potential data after unidentifiable individuals
When the data will become available and for how long
Start the access period from 2019
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
Data can be used for scientific and research studies.
From where data/document is obtainable
Dr Mohammad Ghorghani; Internal Medicine Assistant; Naghizadeh73@yahoo.com
What processes are involved for a request to access data/document
After receiving the request email, data files will be sent in less than a week.