The objective of this study is investigation of cabergoline effects on Rheumatoid arthritis .This study is a cross over clinical trial on Rheumatoid arthritis (ACR 1987 criteria) and activity of RA will be defined as existence of 4 swollen joints and two of these : 6 tender joints, morning stiffness>30 minutes and ESR≥28. Patients should be received DMARDs (diseases modifying slow acting anti rheumatiod drugs)at least for 3-6 months before entry to study .We will not change DMARDs during the intervention but we can joint injection except in third month. Exclusion criteria includes: patient uncompromised, psychological problems, pregnancy and lactation.
This study will be done on 10 patients that will divide in 2 groups with 5 patients in every group.
Cabergoline (1mgr/week) and placebo (once weekly) will be given to patients by another colleague for 3 months.
We record activity criteria and after one month as wash out period, we will change drug to another (cabergoline or placebo). After second 3 months we will record activity criteria again. ESR and prolactin will be measured on 0,3,4,7 months. We will analysis result as change in disease activity (morning stiffness, swollen and tender joints, visual analogue score and ESR, prolactin)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138802061828N2
Registration date:2009-06-29, 1388/04/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2009-06-29, 1388/04/08
Registrant information
Name
Maryam Mobini
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 15 1324 4142
Email address
mmobini@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University of Medical Sciences and Health Services
Expected recruitment start date
2009-05-22, 1388/03/01
Expected recruitment end date
2010-04-21, 1389/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cabergoline on rheumatiod Arthritis patient
Public title
Effect of Cabergoline on rheumatiod Arthritis patient
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patient with Rheumatoid Arthritis (RA) based on ACR (american college of romahthology) 1987 criteria and activity of RA will be defined as existence of 4 swollen joints and two of these : 6 tender joints, morning stiffness>30 minutes and ESR≥28. Patients should be received DMARDs (diseases modifying slow acting anti rheumatiod drugs) at least for 3-6 months before entry to study. Exclusion criteria includes: patient uncompromised, psychological problems, pregnancy and lactation.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mazandaran University of Medical Sciences and Health Services
Street address
Imam Sq, Joybar 3way, Start of valiye asr highway
City
Sari
Postal code
Approval date
empty
Ethics committee reference number
88-18
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05.8
ICD-10 code description
Other seropositive rheumatoid arthritis
Primary outcomes
1
Description
the number of tender joints
Timepoint
before prevention and 3,4 and 7 month after prevention
Method of measurement
taking history and Questionnaire
2
Description
morning stiffness
Timepoint
before prevention and 3,4 and 7 month after prevention
Method of measurement
taking history and Questionnaire
3
Description
the number of swollen joints
Timepoint
before prevention and 3,4 and 7 month after prevention
Method of measurement
examination
4
Description
pain
Timepoint
before prevention and 3,4 and 7 month after prevention
Method of measurement
VAS
Secondary outcomes
1
Description
ESR
Timepoint
before intervention and 3,4 and 7 mounth after treatment
Method of measurement
labratory
2
Description
prolactine
Timepoint
before intervention and 3,4 and 7 mounth after treatment
Method of measurement
labratory
Intervention groups
1
Description
First group: Cabergoline (1mgr/week) for 3 months and after one month as wash out period, we will change drug to placebo
Category
Treatment - Drugs
2
Description
Second group: Placebo (once weekly) for 3 months and after one month as wash out period, we will change placebo to cabergoline (1mgr/week)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tuba clinic
Full name of responsible person
Marayam Mobini
Street address
Khazar Blv
City
Sari
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences and Health Services
Full name of responsible person
Sayed Jalal Hosseini mehr
Street address
Moalem sq.
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences and Health Services
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
Mazandaran Univercity of medical sciences and Health ervices