Study of the effect of Silimarin on the reduction of liver complications of fingolimod in patients with Relapsing-Remitting Multiple Sclerosis (RRMS)
Design
A clinical trial with a control group, with a factorial group, single blind, non-randomized, for 6 months on 48 patients
Settings and conduct
This study will be performed on 48 patients with RRMS receiving Fingolimod for 6 months, referring to Imam Khomeini Clinic of Hamadan city. Patients with RRMS are divided into two groups of 24 people. The first group will receive the Fingolimod alone and the second group will receive, in addition to Fingolimod , a Livergol containing 150mg of Silymarin at a dose of 140 mg once a day. Patients should be checked once for treatment of liver enzymes such as ALT, AST, ALP, and bilirubin, and then for hepatic metabolism of the ALT, AST and ALP enzymes are checked for six months each month.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who have had at least 3 weeks of onset of corticosteroid attack and received corticosteroids with liver enzymes following corticosteroid therapy.
New Patients Receive Fingolimod
Patients who are taking interferon and Glatiramer are advised to take the Fingolimod, provided they have no liver problem.
Expanded Disability Status Scale below three.
Exclusion criteria:
Pregnant and lactating women
Patients who are allergic to Silymarin
Patients with previous history of tuberculosis, HIV, hepatitis and liver problems.
Intervention groups
First group: Fingolimod alone
Second group: Fingolimod with Livergol Product containing 150 mg Silymarin, once a day
Main outcome variables
liver complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150628022956N7
Registration date:2019-07-02, 1398/04/11
Registration timing:retrospective
Last update:2019-07-02, 1398/04/11
Update count:0
Registration date
2019-07-02, 1398/04/11
Registrant information
Name
Sara Ataei
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 440 2319
Email address
s.ataei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-21, 1398/02/31
Expected recruitment end date
2019-06-21, 1398/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of Silimarin on the reduction of liver complications of fingolimod in patients with Relapsing-Remitting Multiple Sclerosis (RRMS)
Public title
The effect of salimarin in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have had at least 3 weeks of onset of corticosteroid attack and received corticosteroids with liver enzymes following corticosteroid therapy.
New Patients Receive Fingolimod
Patients who are taking interferon and Glatiramer are advised to take the Fingolimod, provided they have no liver problem.
Expanded Disability Status Scale below three.
Exclusion criteria:
Pregnant and lactating women
Patients who are allergic to Silymarin
Patients with previous history of tuberculosis, HIV, hepatitis and liver problems.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
A sample of Fingolimod and Silymarin is packed in similar packaging and pass code. The researcher and the patient and the data collectors and those who evaluate the outcome do not know the contents of the pack and randomly give a patient an example.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of the hamedan University of Medical Sciences
Street address
Hamedan, Pazhoohesh Crossroad, In front of the Luna park, Hamedan University of Medical Sciences
City
Hamedan
Province
Hamadan
Postal code
6517838678
Approval date
2019-03-02, 1397/12/11
Ethics committee reference number
IR.UMSHA.REC.1398.166
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
2
Description of health condition studied
Liver disease
ICD-10 code
K76
ICD-10 code description
Other diseases of liver
Primary outcomes
1
Description
liver complications
Timepoint
At the beginning of the study (before the intervention) and 30, 60, 90, 120, 150 and 180 days after taking Silymarin
Method of measurement
Malondialdehyde index with Ohkawa method- Total antioxidant capacity index with FRAP method- Measurement of protein thiol groups with Ellman's Reagent (DTNB)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with multiple sclerosis(RRMS) receiving Fingolimod alone For 6 months
Category
Treatment - Drugs
2
Description
Intervention group: Patients with multiple sclerosis(RRMS) receiving Fingolimod، With Silymarin with a dose of 140 mg once a day for 6 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti Hospital in Hamadan
Full name of responsible person
Dr. Hamid Nafisi
Street address
Ghaem Square, Shahid Beheshti Hospital
City
Hamadan
Province
Hamadan
Postal code
6581773946
Phone
+98 81 3820 8383
Email
drhamidnafisi1372@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Council of Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeed Bashirian
Street address
Hamedan Boulevard, Shahid Fahmidah, facing Hamedan University of Medical Sciences
City
Hamadan
Province
Hamadan
Postal code
6581773946
Phone
+98 81 3838 1675
Email
s.ataei@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of 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
Dr. Sara Ataei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Hamedan Boulevard, Shahid Fahmidah, Facing the People's Park of Hamedan University of Medical Sciences, Faculty of Pharmacy
City
Hamadan
Province
Hamadan
Postal code
6581773946
Phone
+98 81 3838 1953
Email
s.ataei@umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
ِDr. Sara Ataei
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
In front of luna park, Hamedan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1953
Email
s.ataei@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Hamid Nafisi
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
In front of Luna park, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3838 1953
Email
drhamidnafisi1372@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable people
When the data will become available and for how long
1398
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
Use data with source
From where data/document is obtainable
s.ataei@umsha.ac.ir
What processes are involved for a request to access data/document