Comparison of the effect of aspirin and placebo for the treatment of fatigue in multiple sclerosis
Design
Clinical randomized trial with control group ,parallel,triple blind strains,randomized phase3 (40patients)
Settings and conduct
After obtaining informed consent, the FSS questionnaire is given to the patients referred to the private practice or the clinic of Shahid Beheshti Hospital in Kashan, who complain of fatigue, and if they score 4, they are entered into the study. Then the patients are randomly divided into two groups, the first group includes 20 patients with aspirin 325 mg. And the second group, which consists of 20 patients, will be given a placebo. After 6 weeks, the MFIS and FSS questionnaires will be filled again for the patients, and the filled initial questionnaire will be compared.Medicines are made and prepared in the same packaging and appearance and size at Barij Essan Pharmaceutical Company. Then they are used based on the codes that were previously prepared using a table of random numbers.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with multiple sclerosis (age between18-55 years old)who suffer from fatigue
Exclusion criteria:hx of GI bleeding or GI ulcer,pregnancy,Attack of disease in the last 4 weeks( and use of corticosteroid),continuous use of aspirin or NSAID for 4 weeks before the study,consumption of alcohol and drugs,EDSS>6
Intervention groups
40 patients with multiple sclerosis are divided into two groups. One group is given aspirin 325 mg daily and the other group (control group) is given medicine(aspirin 325 mg)
Main outcome variables
Fatigue of the patient
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230802059008N1
Registration date:2023-11-11, 1402/08/20
Registration timing:registered_while_recruiting
Last update:2023-11-11, 1402/08/20
Update count:0
Registration date
2023-11-11, 1402/08/20
Registrant information
Name
Mahtab Karami
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3632 1057
Email address
mahtabkarami303@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2024-04-20, 1403/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of aspirin and placebo for the treatment of fatigue in multiple sclerosis
Public title
Effect of aspirin in fatigue of multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
FSS score>=4
EDSS<=6
Patients with multiple sclerosis (age between18_55)
Exclusion criteria:
Depression
Hypothyroidism
Pregnancy
Anemia
Thrombocytopenia
Hx of GI bleeding ,GI ulcer
Asthma
Alcohol use
MS attack in the last 4weeks that corticosteroid used for treatment
Chronic renal disease
Chronic pulmonary disease
Chronic metabolic disease
Chronic heart disease
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by block method with a number of blocks in phase, starting with all of the 4 blocks, including A and B, which can be easily configured (4 blocks), using a random number table. The random blocks must be selected (26 blocks). 4tai A and B are a combination of these, as they are coincidental, so that they are different from each other.After entering the study ,patients will receive one of the drugs according to the code(from 1to 104) that is registered on the drug's lable.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Drugs are prepared in the same size and packaging in Barij Essence Pharmaceutical Company.Then they are coded using previous random numbers.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Ghotb Ravandi Blvd,Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2023-07-03, 1402/04/12
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1402.058
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
severity of fatigue
Timepoint
Measuring the intensity of fatigue at the beginning of the study (before the start of the intervention) and 42 days after taking aspirin 325 mg and placebo (at the end of the study - 6 weeks later)
Method of measurement
Fatigue severity scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 20 patients are treated with aspirin 325 mg (Produced by Pars Daru Company)daily.The patients are given the necessary training in case of possible side effects related to aspirin. It is available to the patients to contact in case of problems, and then the patients are contacted every two weeks to follow up on the regular use of medicines
Category
Treatment - Drugs
2
Description
Control group:20 patients will be treated with placebo daily.placebo is formed by Barij Essans pharmaceutical company with combination of oisel and wheat starch .It is given in the form of a tablet of the same size as aspirin.each patient uses the medicine once a day.at the beginning of the study ,the patients are given the necessary training in case of possible side effects related to medicine and then the phone number to call in case of problems.then the patients are connected once every two weeks to follow up on the regular use of drugs.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital of Kashan
Full name of responsible person
Mahtab Karami
Street address
Ghotb Ravandi Blvd,Shahid Beheshti hospital
City
Kashan
Province
Isfehan
Postal code
8715988111
Phone
+98 31 5500 9999
Email
Beheshtihospital@kaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahtab Karami
Street address
Ghotb Ravandi Blvd.,Kashan town
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5558 9119
Email
Education@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
50
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
Kashan University of Medical Sciences
Full name of responsible person
Mahtab Karami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
No.10,Iman Jonubi Aven,shiraz town
City
Kashan
Province
Isfehan
Postal code
7188776597
Phone
+98 71 3632 1057
Email
Mahtabkarami303@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahtab Karami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
No.10,Iman Jonubi Ave.,Shirakawa town
City
Kashan
Province
Isfehan
Postal code
7188776597
Phone
+98 71 3632 1057
Email
Mahtabkarami303@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahtab Karami
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Medical Education
Street address
No.10,Iman Jonubi Ave.,Shirakawa town
City
Kashan
Province
Isfehan
Postal code
7188776597
Phone
+98 71 3632 1057
Email
Mahtabkarami303@yahoo.com
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