Objective: Effectiveness of simvastatin on improvement of multiple sclerosis (MS).
Design: Double blind, randomized, blocking study.
Study population: patients with MS, aged between 18 and 60 years.
Inclusion criteria: Relapsing-remitting MS patients; at least 1 relapse in the previous 12 months; more than three lesions on spinal or brain magnetic resonance imaging or both; baseline expanded disability status scale (EDSS) from 0 to 3.5; aged 18–60 years.
Exclusion criteria: clinical CIS syndrome, progressive MS, MS patients with acute clinical relapses occurring during the study, drug abuse, renal failure, pregnancy, hepatitis diseases.
Sample: 60.
Study Intervention: interferon beta-1a and simvastatin .
Time of intervention: Six months after entering the intervention.
The outcome of the study: All the clinical and immunological variables were measured at the baseline and at the end of the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112925284N1
Registration date:2015-12-06, 1394/09/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-06, 1394/09/15
Registrant information
Name
Fardin Faraji
Name of organization / entity
Assistain profosor
Country
Iran (Islamic Republic of)
Phone
+98 51 3849 9144
Email address
farajif@mumc.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Arak University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of simvastatin on improvement of multiple sclerosis (MS).
Public title
Effectiveness of simvastatin on multiple sclerosis (MS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Relapsing-remitting MS patients; at least 1 relapse in the previous 12 months; more than three lesions on spinal or brain magnetic resonance imaging or both; baseline expanded disability status scale (EDSS) from 0 to 3.5; aged 18–60 years.
Exclusion criteria: clinical CIS syndrome, progressive MS, MS patients with acute clinical relapses occurring during the study, drug abuse, renal failure, pregnancy, hepatitis diseases.
Age
From 18 years old to 60 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 Arak University of Medical Sciences
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
3819693345
Approval date
2009-06-22, 1388/04/01
Ethics committee reference number
88-69-1
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
Assay of cell amplification of peripheral blood luokocytes
Timepoint
6 months after entering the intervention
Method of measurement
MTT assay
Secondary outcomes
1
Description
level of cytokines
Timepoint
6 months after entering the intervention
Method of measurement
ELISA
Intervention groups
1
Description
Control group: Received 30 μg interferon beta-1a; intra-muscular injection; for 6-months
Category
Treatment - Drugs
2
Description
Intervention group: Received 30 μg interferon beta-1a with 40 mg atorvastatin; intra-muscular injection; for 6-months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghods Hospital
Full name of responsible person
Kevan Ghsami
Street address
Ghods Hospital, Phelestin Avenue
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Arak University of Medical Sciences
Full name of responsible person
Ali Asghar Yaghobi
Street address
Vice Chancellor for Research, Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Stree
City
Arak
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, Arak 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
Arak University of Medical Sciences
Full name of responsible person
Fardin Faraji
Position
Assistant Professor
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 86 3313 6058
Fax
Email
ghazaviali@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fardin Faraji
Position
Assistant Professor
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 68033136058
Fax
Email
ghazaviali@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fardin Faraji
Position
Assistant Professor
Other areas of specialty/work
Street address
Arak University of Medical Sciences, A'lam-Al-Hoda Street, Shahid Shiroodi Street
City
Arak
Postal code
Phone
+98 68033136058
Fax
Email
ghazaviali@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)