Multiple sclerosis is an autoimmune disease that affected the central nervous system. The most common way for treatment of disease is the use of immunosuppressive drugs. Atorvastatin is a statin family of drugs which is effective in control of cholesterol synthesis.This study investigated the effect of atorvastatin on the Multiple sclerosis disease process.
In this clinical trial study, demographic data were recorded for 60 patients with multiple sclerosis. Patients were divided into two groups. Before treatment, the measurement of immunological parameters at Baseline and MRI were performed. Case group treated for 12 months with 80 mg daily oral atorvastatin. Samples were taken at the end of the study again. At the beginning and end of the study for all patients EDSS and FSS forms were completed.
Inclusion criteria: Informed consent for entering the study and Fill out the form informed consent; MS disease
Exclusion criteria: Side effects of the drug
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071323184N1
Registration date:2015-08-08, 1394/05/17
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-08, 1394/05/17
Registrant information
Name
Keivan Ghasami
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 918 849 2394
Email address
k.ghasami@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of atorvastatin on the disease process in patients with multiple sclerosis
Public title
The effect of atorvastatin on patients with multiple sclerosis
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Informed consent for entering the study and Fill out the form informed consent; MS disease
Exclusion criteria: Side effects of the drug
Age
From 1 year old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak- Sardasht-Arak University of Medical Sciences-Department of Research
City
Arak
Postal code
Approval date
2010-01-25, 1388/11/05
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 (of):generalized
Primary outcomes
1
Description
Cerebellar function
Timepoint
Pretreatment / six months after treatment / one year after treatment.
Method of measurement
Due to physician's viewpoint
2
Description
Visual function
Timepoint
Pretreatment / six months after treatment / one year after treatment.
Method of measurement
Due to physician's viewpoint
3
Description
Sensory function.
Timepoint
Pretreatment / six months after treatment / one year after treatment.
Method of measurement
Due to physician's viewpoint
4
Description
Digestive function - bladder
Timepoint
Pretreatment / six months after treatment / one year after treatment.
Method of measurement
Due to physician's viewpoint
Secondary outcomes
1
Description
Sensitivity to drug
Timepoint
Pretreatment / six months after treatment / one year after treatment
Method of measurement
Due to physician's viewpoint
Intervention groups
1
Description
The control group: There was no intervention and patients had received the routine treatment. The routine treatment was prescribed due to the doctor's viewpoint and based on disease symptoms and the patient's needs and included drugs such as CinnoVex, Betaferon, Baclofen, Amantadine, etc.
Category
N/A
2
Description
The Case group: In case group, patients in addition to routine therapy were treated with oral Atorvastatin 80 mg daily for one year.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Street address
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ghasami
Street address
Arak Vali Asr Square Valiasr Hospital
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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 Neurology Department
Full name of responsible person
Dr Ghasami
Position
Neurology specialist
Other areas of specialty/work
Street address
Arak Valiasr Hospital
City
Arak
Postal code
Phone
+86 32222003
Fax
Email
k.ghasami@arakmu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ghasami
Position
Neurology specialist
Other areas of specialty/work
Street address
Arak- Valiasr Hospital Department of Neurology
City
rak
Postal code
-
Phone
+86 32222003
Fax
Email
k.ghasami@arakmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Ghasami
Position
Neurology specialist
Other areas of specialty/work
Street address
City
Arak
Postal code
Phone
+98 86 3222 2004
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)