The goal of this study is evaluation of oral bromocriptin effect on rheumatoid arthritis disease activity ((DAS28 score). Population study will be rheumatoid arthritis patients referred to the Rheumatology Clinic of Al-zahra Hospital. Sample size in this study is 80. This study is a randomized double blind controlled trial that will start at the spring 2010 and will continue to spring 2011. The primary endpoint is improvement of clinical symptoms and laboratory parameters of patients following oral consumption of bromocriptin.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201008121778N3
Registration date:2010-08-12, 1389/05/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2010-08-12, 1389/05/21
Registrant information
Name
Mansour Salesi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1265 1983
Email address
salesi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Vice chancellor for research
Expected recruitment start date
2010-04-30, 1389/02/10
Expected recruitment end date
2011-04-30, 1390/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Bromocriptin effect on disease activity index in rheumatoid arthritis
Public title
Bromocriptin and rheumatoid arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Rheumatoid arthritis patients (proved by ACR criteria) that greater than 16 years old with active R.A (DAS>4) despite conventional thrapy.
Exclusion criteria: Drug reaction, lapse from the study, Immigration or death, containdications for bromocriptin
Age
From 16 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
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
Isfahan University of Medical Sciences
Street address
Hezar Jarib Boulevard
City
Isfahan
Postal code
8158697851
Approval date
2010-01-10, 1388/10/20
Ethics committee reference number
103425 /4/12/پ
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
Clinical and laboratory findings
Timepoint
Before the study and 3 months later
Method of measurement
DAS28, ESR, VAS, Prolactin
Secondary outcomes
empty
Intervention groups
1
Description
two placebo tablet per day for 3 months
Category
Placebo
2
Description
Bromocriptin oral pills 2.5 mg two tablet per day for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Mansour Salesi
Street address
Sofe Avenue
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of research, Isfahan University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research
Street address
Vice chancellery of research, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of research, Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Mansour Salesi
Position
Rheumatologist/Assistant professor
Other areas of specialty/work
Street address
Hezar Jarib Boulevard
City
Isfahan
Postal code
8158697851
Phone
+98 31 1265 1983
Fax
+98 31 1265 1983
Email
salesi@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mansour Salesi
Position
Rheumatologist/Assistant professor
Other areas of specialty/work
Street address
Hezar Jarib Boulevard
City
Isfahan
Postal code
8158697851
Phone
+98 31 1265 1983
Fax
+98 31 1265 1983
Email
salesi@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Somayeh Sadeghi
Position
Resident of Internal Medicine
Other areas of specialty/work
Street address
Department of Internal Medicine, Al-Zahra Hospital
City
Isfahan
Postal code
Phone
+98 31 1264 7438
Fax
+98 31 1264 7438
Email
s_sadeghi@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)