]>
IRCT20230802059008N1 IRCT 2023-11-11 Kashan University of Medical Sciences Effect of aspirin in fatigue of multiple sclerosis Comparison of the effect of aspirin and placebo for the treatment of fatigue in multiple sclerosis 2023-08-23 anticipated 40 Complete https://irct.ir/trial/71779 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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 description: Drugs are prepared in the same size and packaging in Barij Essence Pharmaceutical Company.Then they are coded using previous random numbers. 3 Multiple Sclerosis. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mahtab Karami
No.10,Iman Jonubi Aven,shiraz town
Kashan Iran (Islamic Republic of) 7188776597 +98 71 3632 1057 Mahtabkarami303@yahoo.com Kashan University of Medical Sciences scientific Mahtab Karami
No.10,Iman Jonubi Ave.,Shirakawa town
Kashan Iran (Islamic Republic of) 7188776597 +98 71 3632 1057 Mahtabkarami303@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) FSS score>=4 EDSS<=6 Patients with multiple sclerosis (age between18_55) 18 years 55 years Both 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 G35 Multiple sclerosis Treatment - Drugs Placebo 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 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. 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. Kashan University of Medical Sciences Approved 2023-07-03 Ethics committee of Kashan University of Medical Sciences Ghotb Ravandi Blvd,Kashan Kashan Isfehan Iran (Islamic Republic of)