Protocol summary

Summary
This study is a controlled, randomized, and double-blind clinical trial that was performed on 60 patients with renal failure aging over 16 and after three months of hemodialysis. All of the patients have been taken testimonial for both N-acetylcystein and placebo provided that, they do not know which group of study (experimental or control) they will be entered. Patients participating in this study, randomly select a numbered card in sealed envelopes in order to enter the control or the experimental group. Giving the medication and randomization process are done by someone who do not intervene in the experiment, accordingly, this study is double-blind. At the beginning of the study, total serum Malondialdehyde is measured as a basis and prior to the prescription of medication or placebo in both groups. Measurement of this marker is done through spectrophotometry method with malondialdehyde kit from merck company of Germany. Then the main group is given 600 mg of N-acetylcysteine twice daily (within 12 hours) for 6 weeks to be taken before meals. To Control the Correct use of medicines, pills and (placebos) are given to patients every week and at the weekend the empty blisters of pills are collected and counted. If a patient did not consume more than 20% of tablets, he would be excluded. The control group is given placebo tablets similar to N-acetylcysteine (2 times a day) within 12 hours in 6 weeks. Placebo was similar to that of N-acetylcysteine tablets in terms of shape, colour and flavour. Its components include: micro-crystalline, cellulose, lactose, corn starch, sorbitol and talc (2% of the total tablet weight). Upon completion of the study period (6 weeks), serum Malondialdehyde, in two groups are measured again using the above mentioned method. Finally, the collected data will be analyzed.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2014031216969N1
Registration date: 2014-07-31, 1393/05/09
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-07-31, 1393/05/09
Registrant information
Name
Ali Javaherforoushzadeh
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1292 1839
Email address
javaherforoushzadeh.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ahvaz Jondishapour University Of Medical Science
Expected recruitment start date
2014-04-21, 1393/02/01
Expected recruitment end date
2014-06-05, 1393/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of N-Acetylcystein on serum Malondialdehyde in comparison with placebo in chronic hemodialysis patients
Public title
Effect of N-Acetylcysteine in hemodialysis patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1) all of the chronic hemodialysis patients due to end stage renal disease more than 18 years old and at least three months has been past from starting of hemodialysis. Exclusion criteria: 1) Every acute disease leads to hospitalization from one month before trial. 2) Allergy to N-acetylcysteine. 3) Hepatic cirrhosis 4) Using Vitamin E or C or every known antioxidant from two weeks before intervention. 5) congestive heart failure or ejection fraction less than 35%. 6) Non using of N-acetylcysteine or placebo more than 20% of total drug.
Age
From 16 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 60
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 Ahvaz Jondishapour University of Medical Sciences
Street address
Vice chancellery for Development, Research and Technology Ahvaz Jondishapour University of Medical Sciences, university city, Golestan St.
City
Ahvaz
Postal code
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
Ajums. Rec.1392.217

Health conditions studied

1

Description of health condition studied
Hemodialysis patients
ICD-10 code
N18
ICD-10 code description
Renal failure

2

Description of health condition studied
Hemodialysis patients
ICD-10 code
N19
ICD-10 code description
Renal failure

3

Description of health condition studied
Hemodialysis patients
ICD-10 code
N17
ICD-10 code description
Renal failure

Primary outcomes

1

Description
Serum Malondialdehyde
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
With malondialdehyde kit spectrophotometry method in mmol/lit

Secondary outcomes

1

Description
Itching
Timepoint
Before intervention and 6 weeks after intervention
Method of measurement
Visual

Intervention groups

1

Description
Intervention group: N-acetylcysteine with the trade name Fluimucil, as 600 milligram tablet, made by Swiss Zambon Svizzerasa company, given twice daily (every 12 hours), per oral for 6 weeks.
Category
Treatment - Drugs

2

Description
Control group: Placebo as 600 milligram tablet, twice daily, every 12 hours, per oral for 6 weeks, made from micro-crystalline cellulose, lactose, corn starch, talk (2% of total tablet weight) which made in pharmacology school of Ahvaz Jondishapour University of Medical Sciences.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Hemodialysis ward of Imam khomeyni Hospital
Full name of responsible person
Shokouh Shayanpour
Street address
Azadegan St. Imam khomeyni Hospital, hemodialysis ward
City
Ahvaz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Development, Research and Technology of Ahvaz Jondishapour University of Medical
Full name of responsible person
Dr.saki nader
Street address
Golestan St. Vice Chancellor for Development, Research and Technology of Ahvaz Jondishapour University of Medical Sciences, University city
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Development, Research and Technology of Ahvaz Jondishapour University of Medical
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
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Ali Javaherforoushzadeh
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Golestan St. Golestan Hospital, Internal Medicine ward
City
Ahvaz
Postal code
6153715794
Phone
+98 61 1374 3013
Fax
+98 61 1374 3013
Email
Ali_javaherforoush@yahoo.com; Javaherforoushzadeh.a@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Shokouh Shayanpour
Position
Associated Professor
Other areas of specialty/work
Street address
Azadegan St. Imam khomeyni Hospital, Nephrology ward
City
Ahvaz
Postal code
6153715794
Phone
+98 61 1374 3013
Fax
+98 61 1292 1839
Email
Dr.shayanpour@yahoo.com; shayanpour.sh@ajums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jondishapour University of Medical Sciences
Full name of responsible person
Ali Javaherforoushzadeh
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Golestan St. Golestan Hospital, Internal Medicine ward
City
Ahvaz
Postal code
6153715794
Phone
+98 61 1374 3013
Fax
+98 61 1374 3013
Email
ali_javaherforoush@yahoo.com; Javaherforoushzadeh.a@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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