Investigation of the effect of N-acetylcysteine on clinical and paraclinical findings in patients with rheumatoid arthritis
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 74 patients.
Settings and conduct
This double-blind clinical trial study will be performed on 74 patients with rheumatoid arthritis. First, patients with rheumatoid arthritis referred to the rheumatology clinic of Shahid Beheshti Hospital in Kashan will be identified based on diagnostic criteria and will be randomly assigned to receive N-acetylcysteine or placebo for 12 weeks. Anthropometric indices at the beginning and 12 weeks after the intervention will be compared.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patient with rheumatoid arthritis who aged 20 to 70 Years old
Exclusion criteria: Unwillingness to cooperate, hypo or hyperthyroidism
use of any supplements (vitamins, minerals and etc) within 3 months prior to enrollment in the study, incidence of intolerable complications and current smokers
Intervention groups
In this study, N-acetylcysteine tablets will be given to the intervention group and placebos that are similar in shape, color and other characteristics to N-acetylcysteine will be given to the control group.
Main outcome variables
Disease activity (DAS28-ESR)
hs-CRP
ESR
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101014004934N2
Registration date:2020-11-25, 1399/09/05
Registration timing:prospective
Last update:2020-11-25, 1399/09/05
Update count:0
Registration date
2020-11-25, 1399/09/05
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
5550030-0361
Email address
kamalesalatmanesh@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-30, 1399/09/10
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study effect of N-acetylcysteine on clinical status and paraclinical outcomes in patients with rheumatoid arthritis
Public title
Investigation of the effect of N-acetylcysteine in rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with rheumatoid arthritis
20 to 70 Years old
Exclusion criteria:
Unwillingness to cooperate
Hypo or hyperthyroidism
Use of any supplements (vitamins, minerals and etc) within 3 months prior to enrollment in the study
Incidence of intolerable complications
Current smokers
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
74
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to a treatment group or placebo based on randomly generated numbers (1 to 74) from the website at (https://stattrek.com/statistics/random-number-generator.aspx). Also, to achieve two equal groups in terms of number of participants, the block randomization method with a ratio of 1 to 1 will be used. Drugs and placebos will be packaged in the same packages by a third party who has no role in the study and only a special code will be written on them. The patients and the investigators will be unaware of the type of intervention and after the end of the study, the codes will be decoded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants, investigators, and outcome assessors will be unaware of the type of intervention until the end of the study. This will be done by encrypting the drug and placebo packages by a third party who has no role in the study, and the codes will be decrypted at the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan University of Medical Sciences, Pezeshk Boulevard, Ghotbe Ravandi Boulevard, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
87159/81151
Approval date
2020-07-13, 1399/04/23
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1399.050
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
Disease activity
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the intervention
Method of measurement
DAS28-ESR (using a questionnaire for VAS and a checklist to note physical examination results)
2
Description
hs-CRP
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the intervention
Method of measurement
Elisa kit
3
Description
ESR
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the intervention
Method of measurement
mm/h
Secondary outcomes
1
Description
Malondialdehyde
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the intervention
Method of measurement
Spectrophotometry
2
Description
Glutathione
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the intervention
Method of measurement
Spectrophotometry
3
Description
Total antioxidant capacity
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the intervention
Method of measurement
Spectrophotometry
4
Description
Morning stiffness duration
Timepoint
At the beginning of the study (before the intervention) and 12 weeks after the intervention
Method of measurement
Minutes
Intervention groups
1
Description
Intervention group: one tablet (600 mg) of N-acetylcysteine (Osvah, Iran) daily
Category
Treatment - Drugs
2
Description
Control group: Patients receiving one placebo tablet daily (Barij Essence, Iran)
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Alireza Jamali
Street address
Shahid Beheshti Hospital, Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
beheshtihospital@kaums.ac.ir
Web page address
http://beheshti.kaums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamidreza Banafsheh
Street address
Kashan University of Medical Sciences, Ghotbe Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 2999
Fax
Email
banafshe57@hotmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice chancellor for research, Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Kamal Esalatmanesh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Shahid Beheshti Hospital, Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
kamalesalatmanesh@kaums.ac.ir
Web page address
http://beheshti.kaums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Kamal Esalatmanesh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Shahid Beheshti Hospital, Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
kamalesalatmanesh@kaums.ac.ir
Web page address
http://beheshti.kaums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Kamal Esalatmanesh
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Rheumatology
Street address
Shahid Beheshti Hospital, Qotb-e Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
87159/81151
Phone
+98 31 5554 0026
Fax
+98 31 5554 8900
Email
kamalesalatmanesh@kaums.ac.ir
Web page address
http://beheshti.kaums.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available