The effect of Silybum marianum on methotrexate-induced hepatotoxicity and its analgesic effect in the patients with rheumatoid arthritis history
Design
Patients will be randomly divided into intervention and control groups (30 patients in each group). The study will be Double-blind and with parallel groups .The intervention group consisted of rheumatoid arthritis patients who received 280 mg of oral silymarin daily for 2 months.The control group consisted of rheumatoid arthritis patients who received of placebo tablets the shape and packaging are quite similar to Silymarin daily for 2 months.
Settings and conduct
The study will be conducted in the Rheumatology units of Amir al-Momenin hospitals. The study will be Double-blind and with parallel groups .The intervention group consisted of rheumatoid arthritis patients who received 280 mg of oral silymarin daily for 2 months.The control group consisted of rheumatoid arthritis patients who received of placebo tablets the shape and packaging are quite similar to Silymarin daily for 2 months.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
1-Age between 16 and 85
2-No history of liver disease
3-taking methotrexate
4- Diagnosis of rheumatoid arthritis with criteria American Collage of Rhematology
Exclusion Criteria:
1-Abnormal liver function tests at admission
2- Dissatisfaction of the patient
3- Pregnancy and lactation
Intervention groups
The intervention group consisted of rheumatoid arthritis patients who received 280 mg of oral silymarin daily for 2 months.The control group consisted of rheumatoid arthritis patients who received placebo tablets the shape and packaging are quite similar to Silymarin daily for 2 months.
Main outcome variables
The impact of Silybum marianum on methotrexate-induced hepatotoxicity and its analgesic effect in the patients with rheumatoid arthritis history patients will be assessed.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180519039711N4
Registration date:2020-02-04, 1398/11/15
Registration timing:prospective
Last update:2020-02-04, 1398/11/15
Update count:0
Registration date
2020-02-04, 1398/11/15
Registrant information
Name
Mohamad Golitaleb
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3506
Email address
m.golitaleb@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Silybum marianum on methotrexate-induced hepatotoxicity and its analgesic effect in the patients with rheumatoid arthritis history
Public title
Effect of silymarin on the liver and pain of rheumatoid arthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 16 and 85
No history of liver disease
taking methotrexate
Diagnosis of rheumatoid arthritis with criteria American Collage of Rhematology
Exclusion criteria:
Unwilling to continue studying
Discharge or death of the patient
Sensitivity to methotrexate
Age
From 16 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly divided into intervention and control groups. Sixty patients were randomly assigned to either the intervention or control groups, initially 6 blocks of 10 different T and C letters (which represent the intervention and control groups) (30) from the intervention group and 30 from the intervention group. People belong to the control group). Then, the blocks were randomly selected to obtain a 60-sided combination of blocks. It opens to tell which group the patient falls into.
Blinding (investigator's opinion)
Double blinded
Blinding description
Clinical caregivers, data analysts, and patients are not aware of being in the control or intervention group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Arak University of Medical Sciences
Street address
Deputy of Education and Research,Campus University of Medical Sciences site,Basij square,Arak
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2019-09-24, 1398/07/02
Ethics committee reference number
IR.ARAKMU.REC.1398.130
Health conditions studied
1
Description of health condition studied
Rheumatoid arthritis
ICD-10 code
M05
ICD-10 code description
Rheumatoid arthritis with rheumatoid factor
Primary outcomes
1
Description
درد
Timepoint
Before and 60 Day after intervention
Method of measurement
Visual Analogue Scale
2
Description
Hepatotoxicity
Timepoint
Before and 60 Day after intervention
Method of measurement
check list
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Take daily with oral 280-mg Silymarin For 2 months
Category
Treatment - Drugs
2
Description
Control group: Control group take under the administration of placebo
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Amiralmomenin Hospital
Full name of responsible person
Mohamad Golitaleb
Street address
Basij square. Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3601
Email
it-amiralmomenin@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/amirhos/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. alireza kamali
Street address
Education and Research Deputy of Arak University of Medical Sciences, Basij Square, Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Web page address
http://arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
masoume garshasbi
Position
nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences. Basij square. Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3503
Email
garshasbimasoume@gmail.com
Web page address
http://arakmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mohamad Golitaleb
Position
Academic instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Pardis Site Of University Of Medical Sciences, Basij Sq, Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3506
Email
m.golitaleb@arakmu.ac.ir
Web page address
http://arakmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
masoume garshasbi
Position
nursing student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Arak University of Medical Sciences. Basij square. Arak
City
Arak
Province
Markazi
Postal code
٣٨١٩٦٩٣٣٤٥
Phone
+98 86 3417 3503
Email
garshasbimasoume@gmail.com
Web page address
http://arakmu.ac.ir/
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 information will be published in the final report and article.
When the data will become available and for how long
The information will be published in the final report and article.
To whom data/document is available
The information will be published in the final report and article.
Under which criteria data/document could be used
The information will be published in the final report and article.
From where data/document is obtainable
The information will be published in the final report and article.
What processes are involved for a request to access data/document
The information will be published in the final report and article.