Comparison of the effect of Cichorium intybus and N-acetylcysteine versus placebo on the reduction of liver complications of Fingolimod in patients with multiple sclerosis: a double-blind randomized clinical trial
To compare the effect of Cichorium intybus and N-acetylcysteine versus placebo on the reduction of liver complications of Fingolimod 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 block randomization to the intervention and control groups
Settings and conduct
This study will be performed in the Sina Hospital in Hamadan city on 63 eligible patients. The patients will be randomly assigned to the intervention and control groups through the block randomization. This trial will be double-blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 to 65 years;
Multiple sclerosis;
At least 3 weeks after receiving corticosteroids;
Exclusion criteria:
Pregnancy and lactation;
History of tuberculosis, AIDS, hepatitis, diabetes, kidney failure, or hypertension
Intervention groups
Intervention group 1:
Tablet Fingolimod 0.5 mg once daily plus capsules containing Cichorium intybus extract 250 mg once daily for 4 months
Intervention group 2:
Tablet Fingolimod 0.5 mg once daily plus capsule containing N-acetylcysteine 1200 mg once daily for 4 months
Control group:
Tablet Fingolimod 0.5 mg once daily plus placebo capsule once daily for 4 months
Main outcome variables
Primary outcome:
Serum levels of liver enzyme (ALT, AST, and bilirubin)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120215009014N410
Registration date:2021-12-08, 1400/09/17
Registration timing:prospective
Last update:2021-12-08, 1400/09/17
Update count:0
Registration date
2021-12-08, 1400/09/17
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
2021-12-31, 1400/10/10
Expected recruitment end date
2022-09-22, 1401/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Cichorium intybus and N-acetylcysteine versus placebo on the reduction of liver complications of Fingolimod in patients with multiple sclerosis: a double-blind randomized clinical trial
Public title
Comparison of the effect of Cichorium intybus and N-acetylcysteine versus placebo on the reduction of liver complications of Fingolimod in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 to 65 years;
Multiple sclerosis;
At least 3 weeks after receiving corticosteroids;
Exclusion criteria:
Pregnancy and lactation;
History of tuberculosis, AIDS, hepatitis, diabetes, kidney failure, or hypertension
Age
From 18 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare six sheets of paper, writing on two sheets the name of the intervention 1 and on two other sheets the name of the intervention 2 and on the third two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all six sheets are drawn. The six paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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 physician who will examine 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
2021-11-29, 1400/09/08
Ethics committee reference number
IR.UMSHA.REC.1400.696
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
Serum levels of liver enzyme (ALT, AST, and bilirubin)
Timepoint
2 and 4 months after the intervention
Method of measurement
through laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1:Tablet Fingolimod 0.5 mg once daily plus capsules containing Cichorium intybus extract 250 mg once daily for 4 months
Category
Treatment - Drugs
2
Description
Intervention group 2:Tablet Fingolimod 0.5 mg once daily plus capsule containing N-acetylcysteine 1200 mg once daily for 4 months
Category
Treatment - Drugs
3
Description
Control group:Tablet Fingolimod 0.5 mg once daily plus placebo capsule once daily for 4 months
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Davood Sarmadi Khojasteh
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
skhdavid@yahoo.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
Davood Sarmadi Khojasteh
Position
Student of Pharmacy
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
skhdavid@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Sara Ataei
Position
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
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
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