Evaluation of effect of N-acetylcysteine on inflammatory markers in hemodialysis patients who referred to Shahid Beheshti hospital, Yasuj, Iran in 2015
The purpose of this study is evaluation of effect of N-acetylcysteine on inflammatory markers in hemodialysis patients who referred to Shahid Beheshti hospital, Yasuj, Iran in 2015. Patients who dialyses at least two times per week for a 3 month period were included, and patients who take anti-inflammatory drugs such as steroids; patients who have active infectious disease, malignancy, kidney transplantation or rheumatic diseases were excluded.This double blind ( for patients and physicians) RCT study is conducted on 40 hemodialysis patients who referred to the hemodialysis ward of Shahid Beheshti hospital in Yasuj city. Patients randomly were divided in to intervention and control group and receive N-acetylcysteine and placebo for 2 month period, respectively .For all patients before and after treatment, inflammatory markers such as: CRP -ESR-IL-6 -TG-Chol-Alb-Ferritin-Cr-PTH and etc. will checked and compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015062222869N1
Registration date:2015-10-22, 1394/07/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-22, 1394/07/30
Registrant information
Name
Moslem Sedaghattalab
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0163
Email address
m.sedaghattalab@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yasuj University of Medical Science
Expected recruitment start date
2015-09-10, 1394/06/19
Expected recruitment end date
2015-11-21, 1394/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of N-acetylcysteine on inflammatory markers in hemodialysis patients who referred to Shahid Beheshti hospital, Yasuj, Iran in 2015
Public title
Effect of N-acetylcysteine on inflammatory markers in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients aged > 18 years; patients who were dialysed at least two times per week for a 3 month period
Exclusion criteria:patients who take anti-inflammatory drugs such as steroids; patients who have active infectious disease, malignancy, kidney transplantation, rheumatic diseases
Age
From 24 years old to 88 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Science
Street address
Postal code 75917-41417, Yasuj University of Medical Science, Motahari street, Yasuj city
City
Yasuj
Postal code
75917-41417
Approval date
2015-09-09, 1394/06/18
Ethics committee reference number
yums.REC.1394.7
Health conditions studied
1
Description of health condition studied
End stage renal disease
ICD-10 code
N18.5
ICD-10 code description
End stage kidney disease
Primary outcomes
1
Description
Interleukin-6
Timepoint
2 month
Method of measurement
ELIZA
2
Description
CRP
Timepoint
2 month
Method of measurement
ELIZA
Secondary outcomes
1
Description
Drug reaction
Timepoint
2 month
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group: N-acetylcysteine tab, 600 mg bid for 2 month period
Category
Treatment - Drugs
2
Description
control group: placebo tab bid, for 2 month period
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis ward of Shahid Beheshti hospital
Full name of responsible person
Street address
City
Yasuj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Yasuj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Street address
Postal code 75917-41417, Yasuj University of Medical Sciences, Motahari street, Yasuj city
City
Yasuj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Yasuj University of Medical Sciences