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Clinical trial to evaluate the effect of rosuvastatin as adjunctive therapy on cytochrome b-245 beta chain (CYBB) gene expression in patients with multiple sclerosis

Protocol summary

Study aim
Determining the effect of oral rosuvastatin on cytochrome b-245 beta chain (CYBB) gene expression to help treat and reduce disability in patients with multiple sclerosis
Design
This research project is a before-after clinical trial, single group, 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 the Neshat Clinic of Hamadan and Beheshti Hospital of Hamadan (Hamadan University of Medical Sciences).
Participants/Inclusion and exclusion criteria
Inclusion criteria: multiple sclerosis patients with a definitive diagnosis by a neurologist; MRI findings consistent with the clinical diagnosis of multiple sclerosis. Exclusion criteria: People who take any combination; or drugs with antioxidant effects other than prescription drugs.
Intervention groups
This study is a before-after study that has only one intervention group; Rosuvastatin 20 mg tablets + standard treatment
Main outcome variables
cytochrome b-245 beta chain (CYBB) gene expression, Expanded Disability Status Scale ( EDSS) score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210211050323N3
Registration date: 2022-02-24, 1400/12/05
Registration timing: prospective

Last update: 2022-02-24, 1400/12/05
Update count: 0
Registration date
2022-02-24, 1400/12/05
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
2022-04-04, 1401/01/15
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial to evaluate the effect of rosuvastatin as adjunctive therapy on cytochrome b-245 beta chain (CYBB) gene expression in patients with multiple sclerosis
Public title
The effect of rosuvastatin in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
History of multiple sclerosis at least one year ago 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 The consistency of the main treatment of patients and the use of a specific type of drug 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 drugs with antioxidant effects except prescription drugs The existence of any cognitive or behavioral disorders with an effect on the patient's cooperation
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
2021-11-27, 1400/09/06
Ethics committee reference number
IR.UMSHA.REC.1400.697

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
Cytochrome b-245 beta chain (CYBB) 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
No additional information.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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