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The effect of pentoxifylline on reducing incidence of restless leg syndrome in patients undergoing hemodialysis

Protocol summary

Study aim
Determine the effect of pentoxifyllin on reducing the incidence of restless leg syndrome
Design
clinical trial with 2 different group and blinded by delivering the encrypted cards to the patients by secretary
Settings and conduct
This study is contains 2 different group of patients that blinded by delivering the encrypted cards to the patients by secretary .
Participants/Inclusion and exclusion criteria
All the patients that undergoing dialysis that give informed consent
Intervention groups
20 patients that undergoing dialysis treated with pentoxifylline and 20 with placebo
Main outcome variables
Pain and leg comfort

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180219038797N1
Registration date: 2018-04-20, 1397/01/31
Registration timing: registered_while_recruiting

Last update: 2018-04-20, 1397/01/31
Update count: 0
Registration date
2018-04-20, 1397/01/31
Registrant information
Name
Reza Saberirad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3881 1341
Email address
rsaberirad@medsab.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-06-05, 1397/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pentoxifylline on reducing incidence of restless leg syndrome in patients undergoing hemodialysis
Public title
Effect of pentoxifylline on restless leg syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the patients undergoing hemodialysis that have Informed consent
Exclusion criteria:
Patient dissatisfaction Death
Age
No age limit
Gender
Both
Phase
0
Groups that have been masked
  • Participant
  • Investigator
  • Data and Safety Monitoring Board
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Delivery of encrypted cards by secretary to patients
Blinding (investigator's opinion)
Triple blinded
Blinding description
Delivering the encrypted cards to the patients by secretary
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Sabzevar University of Medical Scienses
Street address
Tawhid settlement , University compound of Sabzevar University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9613873136
Approval date
2018-02-19, 1396/11/30
Ethics committee reference number
IR.MEDSAB.REC.1396.138

Health conditions studied

1

Description of health condition studied
Restless Leg Syndrome
ICD-10 code
G25.81
ICD-10 code description
Restless legs syndrome

Primary outcomes

1

Description
Pain and comfort of legs
Timepoint
At the end of each month for 3 months
Method of measurement
Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: prescription of 1 pentoxifylline tablet (400 mg) daily for 3 months
Category
Treatment - Drugs

2

Description
Control group: prescription of 1 placebo daily for 3 months
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Vaseei Hospital
Full name of responsible person
Zahra Mirhoseini
Street address
Touhid shahr Blvd , Sabzevar
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4465 1300
Email
rsaberirad@medsab.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Mirhoseini
Street address
University compound , Touhid shahr Blvd,
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4401 1300
Email
rsaberirad@medsab.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sabzevar 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
Sabzevar University of Medical Sciences
Full name of responsible person
Reza Saberi Rad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 6 Boustan Ave , 24 metri enghelab Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4464 7777
Email
rsaberirad@medsab.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Zahra Mirhoseini
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
No 75 , 40th Honarestan Ave , Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9178143630
Phone
+98 51 3849 2011
Email
zahra_mir2002@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Sabzevar University of Medical Sciences
Full name of responsible person
Reza Saberi Rad
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
General Practitioner
Street address
No 6 Boustan Ave , 24 meters Enghelab Blvd
City
Sabzevar
Province
Razavi Khorasan
Postal code
9613873136
Phone
+98 51 4464 7777
Email
rsaberirad@medsab.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data, including a questionnaire, can be shared.
When the data will become available and for how long
3 months after the results
To whom data/document is available
University researchers
Under which criteria data/document could be used
Researchers in the field
From where data/document is obtainable
Zahra Mirhoseini Vase`ee Hospital Sabzevar 00989155081275 zahra_mir2002@yahoo.com
What processes are involved for a request to access data/document
The researchers submit their application via email.
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