Objective: Assessment of Pentoxifylline effect in reduction of serum C-Reactive Protein (CRP) level in hemodialysis patients. Methods: 66 patients entered in this single blind clinical trial. None of them had a inflammatory situation (such as connective tissue Dis., active infections, malignancies, recent traumas, wounds and etc ...) and none of them had taken any anti-inflammatory drugs in 2 months prior to trial. There was no excluding factor of age & sex. They randomly were divided in two groups with 33 patients in each other: One group received 400mg of Pentoxifylline daily (Case group) and another group received placebo (Control Group). Serum CRP level measured at the beginning and end of the trial (after 4 Months) for both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138901293744N1
Registration date:2010-06-20, 1389/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-20, 1389/03/30
Registrant information
Name
Arash Kordi
Name of organization / entity
Qazvin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 28 1333 2930
Email address
akordi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Qazvin University of Medical Sciences
Expected recruitment start date
2009-07-23, 1388/05/01
Expected recruitment end date
2009-08-23, 1388/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of Pentoxifylline effect in reduction of serum C-Reactive Protein (CRP) level in hemodialysis patients in Booali Sina's hemodialysis center
Public title
Pentoxifylline effect in reduction of serum C-Reactive Protein (CRP) level in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: hemodialysis patients with ESRD (ٍEnd Stage Renal Disease) in Booali Sina's hemodialysis center. Exclusion criteria: history of Hypersensitivity to Pentoxifylline, Xanthines (eg, caffeine, theophylline), or any component of the formulation; recent cerebral and/or retinal hemorrhage; inflamatory situations (such as connective tissue Dis., diabetic foot and other vascular problems, active infections, malignancies, recent traumas, wounds and surgeries); and take any anti-inflamatory drugs in 2 months prior to trial.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical and research commitee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Postal code
Approval date
2009-01-09, 1387/10/20
Ethics committee reference number
2744/20/28
Health conditions studied
1
Description of health condition studied
ٍEnd Stage Renal Disease
ICD-10 code
N18.0
ICD-10 code description
ٍEnd Stage Renal Disease
Primary outcomes
1
Description
serum CRP
Timepoint
Before intervention and four months later
Method of measurement
mg/liter with lab-kit(nephlometry)
Secondary outcomes
empty
Intervention groups
1
Description
Pentoxifylline tablet 400 mg/daily for 4 months in intervention group
Category
Treatment - Drugs
2
Description
Pacebo tablet /daily for 4 months in control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Booali Sina's hospital
Full name of responsible person
Street address
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hossin Sheykhi
Street address
Shahid Bahonar Blvd
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mahmood Ali Keshavarz
Position
Internal medicine residency
Other areas of specialty/work
Street address
Booali Sina's hospital, Naderi cross
City
Qazvin
Postal code
Phone
+98 28 1333 2930
Fax
+98 28 1332 6033
Email
keshavarz.2008@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Arash Kordi
Position
Nephrologist
Other areas of specialty/work
Street address
Qazvin University of Medical Sciences, Shahid Bahonar Blvd.
City
Qazvin
Postal code
Phone
+98 28 1333 2930
Fax
+98 28 1332 6033
Email
akordy@yahoo.comakordi@qums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Mahmood Ali Keshavarz
Position
Internal medicine residency
Other areas of specialty/work
Street address
Booali Sina's hospital, Naderi cross
City
Qazvin
Postal code
Phone
+98 28 1333 2930
Fax
Email
keshavarz.2008@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)