The study of Livergol® effect on serum levels of tumor necrosis factor- α, malondialdehyde, interleukin-1,paraoxonase-1, catalase and neopterin in rheumatoid arthritis patients
50 patients with Rheumatoid Arthritis diagnosed by a Rheumatologist and patient are free to participate in this study, they are received daily 3 tablets of 140 mg livergol® for 3 months as adjuvant addition regimen routinely receive. During this study ,before and after intervention, blood sample was collected from patients. blood samples will be analyzed in the following way:
Evaluating the changes of TNF-α and interleukin-1 by ELISA kits systems.
Evaluating the changes of Neopetrine and Malondialdehyde by HPLC system.
Evaluating the changes of catalase, and paraoxonase by spectrophotometry system.
The data were analyzed by spss16 software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121915870N1
Registration date:2015-05-23, 1394/03/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-23, 1394/03/02
Registrant information
Name
Amir Kiani
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 6482
Email address
akiani@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Kermanshah University of Medical Sciences
Expected recruitment start date
2014-09-07, 1393/06/16
Expected recruitment end date
2014-12-07, 1393/09/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of Livergol® effect on serum levels of tumor necrosis factor- α, malondialdehyde, interleukin-1,paraoxonase-1, catalase and neopterin in rheumatoid arthritis patients
Public title
The study of Livergol® effect on rheumatoid arthritis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: having four of the seven criteria, of American College of Rheumatology for six weeks and Diagnosis by a Rheumatologist
Exclusion criteria: Patients participating in the study will be free to withdraw from the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
In this study the Matrix Metalloproteinase 2,9(MMP2 ,MMP9) and vascular endothelial growth factor(VEGF) were measured.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Science
Street address
Shahid Beheshti Bolva, Kermanshah, Iran
City
Kermanshah
Postal code
6714869914
Approval date
2014-09-06, 1393/06/15
Ethics committee reference number
23322
Health conditions studied
1
Description of health condition studied
rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Seropositive rheumatoid arthritis
Primary outcomes
1
Description
interleukin 1
Timepoint
before and after advising the drug
Method of measurement
ELISA
2
Description
TNF-a
Timepoint
before and after advising the drug
Method of measurement
ELISA
3
Description
neopterin
Timepoint
before and after advising the drug
Method of measurement
HPLC
4
Description
Malondialdehyde
Timepoint
before and after advising the drug
Method of measurement
HPLC
5
Description
catalase
Timepoint
before and after advising the drug
Method of measurement
spectrophotometry system
6
Description
paraoxonase
Timepoint
before and after advising the drug
Method of measurement
spectrophotometry system
Secondary outcomes
1
Description
ESR
Timepoint
before and after the drug
Method of measurement
westregreen
2
Description
CRP
Timepoint
before and after the drug
Method of measurement
ELISA
3
Description
mmp-2
Timepoint
before and after the drug
Method of measurement
ELISA and gelatin zymography
4
Description
mmp-9
Timepoint
before and after the drug
Method of measurement
ELISA and gelatin zymography
Intervention groups
1
Description
daily 3 tablets of 140 mg livergol® for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Medicine, Kermanshah University of Scince
Full name of responsible person
Dr.Amir Kiani
Street address
School of Medicine, Kermanshah University of Scince
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Farid najafi
Street address
Vice Chancellery of Research & Technology Affairs, shahid beheshti blv, kermanshah
City
kermanshah
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 Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.Amir Kiani
Position
PHD of toxicology
Other areas of specialty/work
Street address
School of Medicine, Kermanshah University of Medical Sciences , Kermanshah
City
Kermanshah
Postal code
Phone
+91 88316929
Fax
Email
amir1kiani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr.amir kiani
Position
PHD of TOXICOLOGY
Other areas of specialty/work
Street address
Kermanshah University of Medical Sciences
City
Kermanshah
Postal code
Phone
+91 88316929
Fax
Email
amir1kiani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
School of Pharmacy, Kermanshah Universuty of Medical Science
Full name of responsible person
Mehrdad Shavandi
Position
Student of Pharmacy
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
mehrdad.shavandi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)