This study was designed to evaluate the effect of montelukast with gabapentin on the improvement of uremic pruritus in dialysis patients.
Design
In this study, 50 dialysis patients with pruritus were divided into two groups: Montelukast and Gabapentin capsules group (25 patients for each group). The clinical trial phase of this study is 3. It is a random block division. This study is a double-blind study. In this study, before the intervention and after 8 weeks of capsule use, the amount of pruritus was measured using the VAS questionnaire.
Settings and conduct
The study site is Arak University of Medical Sciences. First, the pruritus rate of dialysis patients is measured. If they have the conditions to study, they are randomly divided into two groups. One group receives the Montelukast capsule and the other group receives the gabapentin capsule. This study is a double-blind study that participants and statistical analysts do not know the groups. At the end of the 8-week intervention phase, the level of pruritus in these participants are measured again and the effectiveness of the Montelukast capsule is compared with that of gabapentin capsule.
Participants/Inclusion and exclusion criteria
Dialysis patients with uremic pruritus and a history of hemodialysis for at least 6 months are included in the study. Patients with skin diseases and patients taking drugs that cause itching will not be included in the study. If a participant becomes allergic to these drugs while studying or is unable to continue the study, he will be excluded from the study.
Intervention groups
Montelukast capsules group: This group consumes two capsules of Montelukast daily for 8 weeks. Gabapentin capsule group: This group takes two gabapentin capsules daily for 8 weeks.
Main outcome variables
Pruritus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180617040114N3
Registration date:2020-12-02, 1399/09/12
Registration timing:registered_while_recruiting
Last update:2020-12-02, 1399/09/12
Update count:0
Registration date
2020-12-02, 1399/09/12
Registrant information
Name
jamal Amri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3502
Email address
jamal.amri71@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-29, 1399/04/09
Expected recruitment end date
2020-12-09, 1399/09/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Montelukast with gabapentin in reducing uremic pruritus in hemodialysis patients
Public title
The effect of Montelukast and Gabapentin on pruritus in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients diagnosed with chronic renal failure
Equal number of dialysis sessions per week
Do not take itching drugs
Perform hemodialysis for at least 6 months
Exclusion criteria:
Having skin diseases
Patients whose hemodialysis has been stopped for any reason or is on the kidney transplant list
Lack of uremic pruritus
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
To assign individuals to two groups of Montelukast capsules and Gabapentin capsules, the block randomization method will be used using Random allocation software with 4, 6 and 8 block sizes, which will be observed by using this method of concealment.In this method, each person is assigned a unique code and pasted on the drug packages, which will also help the blinding process.
Blinding (investigator's opinion)
Double blinded
Blinding description
First, it will be explained about the study to the participants.
This study is a double blind study.
One group is given Montelukast capsules and the other group is given gabapentin capsules. These capsules are completely similar and they do not know the contents of the capsules.
The statistical analyst is not informed about the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Arak University of Medical Sciences,Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2020-06-27, 1399/04/07
Ethics committee reference number
IR.ARAKMU.REC.1399.128
Health conditions studied
1
Description of health condition studied
Dialysis patients
ICD-10 code
T81.502
ICD-10 code description
Unspecified complication of foreign body accidentally left in body following kidney dialysis
Primary outcomes
1
Description
Pruritus rate
Timepoint
It is measured one day before the intervention and 8 weeks after the intervention
Method of measurement
Using Visual analogue scale questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group is given Montelukast capsules. At the beginning of the study, a dose of 100 mg will be given to individuals, and after follow-up, if there are no side effects, the dose will be gradually increased and eventually reach a dose of 300 mg. Take two capsules for 8 weeks. This capsule is made by Raha Pharmaceutical Company of Isfahan
Category
Treatment - Drugs
2
Description
Intervention group: This group is given gabapentin capsules. The dose is 10 mg. Two capsules are taken for 8 weeks. This capsule is made by Obidi Pharmaceutical Company.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
The Half-State Center for Supportive Dialysis in Arak(Hami)
Full name of responsible person
Nasser Saeedi
Street address
Gerdu Town, Arak, Markazi Province,
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3477 9080
Email
nassersaedi47@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Alireza Kamali
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
research@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Amirreza laripourtehranfar
Position
Residency
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
amirreza_als@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nasser Saeedi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Arak University of Medical Sciences, Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
nassersaedi47@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
amirreza laripourtehranfar
Position
Residency
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Arak University of Medical Sciences,Basij Square
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
amirreza_als@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available