Determination of Silymarin therapeutic effect in multiple Sclerosis patients receiving CinnoVex
Design
In this study, 60 patients with Multiple Sclerosis who have been admitted to Kashani Hospital in Isfahan are selected. Participants are randomly divided into intervention and control groups and each participant is assigned a code.
Settings and conduct
Patients referring to the Kashani hospital in Isfahan must be approved by the neurologist for the diagnosis of multiple sclerosis. Perform all stages of the test with patients satisfaction. These multiple sclerosis patients will be included in a randomized, double blind clinical trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The study population is among people with multiple sclerosis who are in the Kashani medical center in Isfahan, who use Synovox drug for less than 1 year.
Exclusion criteria:
Patients with multiple sclerosis treated with other interferon beta drugs and immunosuppressive drugs, as well as patients who have already received sinoox and their treatment discontinued, are excluded.
Intervention groups
Intervention group:
Patients with Multiple Sclerosis treated with CinnoVex and Silymarin
Control group:
Patients with multiple sclerosis treated with CinnoVex and placebo
Evaluation of Silymarin therapeutic effect in multiple sclerosis patients receiving CinnoVex
Public title
Silymarin in multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with multiple sclerosis who go to Kashani hospital in Isfahan.
Patients taking CinnoVex for less than 1 year.
Exclusion criteria:
Patients with multiple sclerosis treated with other interferon beta drugs and immunosuppressive drugs
Patients who have already received CinnoVex and their treatment has been discontinued
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random random, clustered using random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
The pills are in the same boxes. Medication and placebo are coded while the physician and the pharmacy and patients do not know the codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
Ir.mui.rec.1395.1.012
Health conditions studied
1
Description of health condition studied
Therapeutic effect of silymarin
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Serum interleukin level 10
Timepoint
2 months before the intervention, 6 months after the intervention
Method of measurement
ELISA
2
Description
Serum interleukin level 17
Timepoint
2 months before the intervention, 6 months after the intervention
Method of measurement
ELISA
3
Description
Serum interleukin level 23
Timepoint
2 months before the intervention, 6 months after the intervention
Method of measurement
ELISA
4
Description
Serum interleukin level 35
Timepoint
2 months before the intervention, 6 months after the intervention
Method of measurement
ELISA
5
Description
Serum interferon gamma
Timepoint
2 months before the intervention, 6 months after the intervention
Method of measurement
ELISA
6
Description
Serum level of tumor growth factor beta
Timepoint
2 months before the intervention, 6 months after the intervention
Method of measurement
ELISA
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Silymarin tablets, 140 mg, 3 times a day, for 6 months, orally
Category
Treatment - Drugs
2
Description
Control group: Placebo tablets, 140 mg, 3 times a day, for 6 months, orally
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani hospital
Full name of responsible person
Vahid Shaygannejad
Street address
Kashani hospital, Kashani street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Shaygannejad@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ahmad Movahedian Attar
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Shaygannejad@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Vahid Shaygannejad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Shaygannejad@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vahid Shaygannejad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Shaygannejad@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vahid Shaygannejad
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Neurology
Street address
Isfahan University of Medical Sciences, Hezarjerib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
Shaygannejad@med.mui.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