Effect of Sylimarin versus placebo on the reduction of liver complication of Teriflunomide in patients with multiple sclerosis: a double-blind randomized clinical trial
To assess the effect of Sylimarin versus placebo on the reduction of liver complication of Teriflunomide in patients with multiple sclerosis
Design
This is a double-blind randomized clinical trial with control group, phase III, in which eligible patients will be randomly assigned through the drawing of lots to the intervention and control groups. This trial will be double-blinded.
Settings and conduct
This study will be performed in the Neshat Clinic in Hamadan city on 42 eligible patients with multiple sclerosis. The patients will be randomly assigned to the intervention and control groups through the drawing of lots. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Multiple sclerosis
Exclusion criteria:
Pregnancy or breastfeeding
Alcohol consumption
Active viral hepatitis or chronic liver disease
Intervention groups
Intervention group:
Triflunomide tablet 14 mg daily plus silymarin tablet 140 mg twice daily for 2 months
Control group:
Triflunomide tablet 14 mg daily plus placebo tablet (starch) twice a day for 2 months
Main outcome variables
Primary outcome:
Liver and biliary function tests (including AST, ALT, ALP, bilirubin and GGT)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N467
Registration date:2023-04-04, 1402/01/15
Registration timing:prospective
Last update:2023-04-04, 1402/01/15
Update count:0
Registration date
2023-04-04, 1402/01/15
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Sylimarin versus placebo on the reduction of liver complication of Teriflunomide in patients with multiple sclerosis: a double-blind randomized clinical trial
Public title
Effect of Sylimarin versus placebo on the reduction of liver complication of Teriflunomide in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 70 years
Multiple sclerosis
Exclusion criteria:
Pregnancy or breastfeeding
Alcohol consumption
Active viral hepatitis or chronic liver disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The shape of the medications and placebos will be perfectly the same. Therefore, patients will be unaware of the type of intervention. The person who performs the randomization will be different from the person who examines the patients, so the person who examines the patients will not be aware of the intervention. Thus, the trial will be run as double-blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2022-10-29, 1401/08/07
Ethics committee reference number
IR.UMSHA.REC.1401.647
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
Liver and biliary function tests (including AST, ALT, ALP, bilirubin and GGT)
Timepoint
Before the intervention and one and two months after the intervention
Method of measurement
By laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Triflunomide tablet 14 mg daily plus silymarin tablet 140 mg twice daily for 2 months
Category
Treatment - Drugs
2
Description
Control group: Triflunomide tablet 14 mg daily plus placebo tablet (starch) twice a day for 2 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Neshat Clinic in Hamadan city
Full name of responsible person
Rezvan Norouzi
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
rezvannorouzi11@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Reza Shokoohi
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
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
Rezvan Norouzi
Position
Pharmacolog Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
rezvannorouzi11@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Shahabedin Emami
Position
Clinical Pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
School of Pharmacy, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
sha_emami@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available