Determining the effect of oral rosuvastatin on Sirtuin1 gene expression to help treat and reduce disability in patients with multiple sclerosis
Design
This research project is a clinical trial before and after, single , phase 2. 40 patients will be included in the study and will be followed up for 3 months.
Settings and conduct
The study will be performed in Neshat Clinic of Hamadan and Beheshti Hospital of Hamadan (Hamadan University of Medical Sciences). This study will be a before and after clinical trial in which a group of 40 people will receive the interventions and the interventions are the same for everyone.
Participants/Inclusion and exclusion criteria
This study was performed on multiple sclerosis patients by a neurologist with a definitive diagnosis. MRI radiological findings are consistent with the clinical diagnosis of multiple sclerosis. , Done. People who take any combination or drug with antioxidant effects other than prescription drugs are not included in the study.
Intervention groups
This study is a before and after study that has only one group and the interventions are the same for everyone. Rosuvastatin 20 mg tablets + standard treatment
Main outcome variables
Sirtuin1 gene expression, Expanded Disability Status Scale ( EDSS) score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210211050323N2
Registration date:2021-10-07, 1400/07/15
Registration timing:registered_while_recruiting
Last update:2021-10-07, 1400/07/15
Update count:0
Registration date
2021-10-07, 1400/07/15
Registrant information
Name
Maryam Etminaniesfahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1590
Email address
m.etminani@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-03, 1400/07/11
Expected recruitment end date
2021-11-02, 1400/08/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the effect of rosuvastatin adjuvant therapy on Sirtuin1 gene expression in the treatment of multiple sclerosis
Public title
The effect of rosuvastatin in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of multiple sclerosis by a neurologist
Radiographic findings of magnetic resonance imaging ( MRI ) consistent with the clinical diagnosis of multiple sclerosis
No other concomitant inflammatory disease
Bad cholesterol levels (low-density lipoprotein) less than 130 mg / dL
No pregnancy and lactation
Do not take medications other than standard treatments for multiple sclerosis that alter the levels of the factors under consideration.
Do not use any combination with antioxidant effects in the past month.
Exclusion criteria:
Existing evidence based on increased patient disability
Consumption of any combination or drug with antioxidant effects except prescription drugs
Existence of any cognitive or behavioral disorders that lead to the patient not cooperating.
Age
From 20 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838687
Approval date
2021-09-25, 1400/07/03
Ethics committee reference number
IR.UMSHA.REC.1400.503
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
Sirtuin1 gene expression
Timepoint
Before the intervention and 3 months after the start of the intervention
Method of measurement
Laboratory
Secondary outcomes
1
Description
Expanded Disability Status Scale (EDSS ) score
Timepoint
Before the intervention and 3 months after the start of the intervention
Method of measurement
Expanded Disability Status Scale (EDSS) questionnaire
Intervention groups
1
Description
Intervention group: Resvostatin, 20 mg tablets, once daily, for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Neshat Clinic of Hamedan University of Medical Sciences
Full name of responsible person
Ali Saghafi
Street address
Isar Rehabilitation Center , Eram Blvd. , Hamedan
City
Hamedan
Province
Hamadan
Postal code
6515911111
Phone
+98 81 3821 8658
Fax
+98 81 3821 8658
Email
info_hmd@isaarcsi.ir
Web page address
http://hmd.isaarcsi.ir
2
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital
Full name of responsible person
Dr. Seyed Mehdi Hosseini
Street address
Shahid Beheshti Medical Center, at the beginning of Eram Boulevard, Ghaem Square, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3371565179
Phone
+98 81 3838 0283
Fax
+98 81 3838 1035
Email
Shahidbeheshti@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
s_bashirian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Atminani Esfahani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3252 0182
Email
m.etminani@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Atminani Esfahani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3252 0182
Email
m.etminani@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Maryam Atminani Esfahani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan University of Medical Sciences , Shahid Fahmideh St. , Hamedan
City
Hamedan
Province
Hamadan
Postal code
6517838687
Phone
+98 81 3252 0182
Email
m.etminani@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD