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IRCT20201216049736N1 IRCT 2020-12-31 Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences An effectiveness and safety comparison study of N-acetylcysteine and amantadine on fatigue and Disability and quality of life of multiple sclerotic patients Clinical trial comparing the efficacy and safety of N-acetylcysteine and amantadine on fatigue and disability and quality of life of patients with MS 2021-01-04 anticipated 112 Complete https://irct.ir/trial/53136 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: All patients will continue their treatment regimen as before and also the first group will be treated with N-acetylcysteine ​​tablets (Exir Company) at a dose of 600 mg every 12 hours. While for the second group, Amantadine capsules of Ammorel brand (Amin Company) will be prescribed at a dose of 100 mg every 12 hours. The duration of treatment will be 6 weeks. Patients' adherence to drug treatment will be reviewed by telephone and during one call per week by the physician in charge of the project, and during this call, possible symptoms and side effects will be questioned. Patients will be visited at the end of the treatment period and EDSS, FSS and MSQOL54 will be calculated for them, Randomization description: Subjects were randomly divided into two groups based on the method of four random blocks.The site at sealedenvelope.com was used for randomization.If we call the two groups A and B, the logic of randomization is that out of 6 blocks, BBAA, ABBA, ABAB, AABB, BAAB and BABA, we select as many samples by placement (ie as n / 4) to Consider the sample size, Blinding description: N-acetylcysteine ​​and amantadine are packaged in such a way that the patient does not know the name of the drug he is taking. In the case of amantadine, a darkly labeled drug pack prepared by a non-research nurse removes the amantadine capsules from the original package and places them in these sachets (20 capsules per pack). In the case of N-acetylcysteine, this drug will be produced in the same factory packaging due to its sensitivity to water, but with a concealment label so that the name of the drug is not known. These drugs will be provided to patients by a nurse unrelated to the research, so that the physician responsible for the registration and final analysis of the plan will not be aware of the drug provided to each patient. 3 Multiple sclerosis. Intervention 1: Intervention group: The first group will be treated with N-acetylcysteine tablets (Exir Company) at a dose of 600 mg every 12 hours. Intervention 2: Intervention group: The second group will receive Amantadine Capsules, brand Amorel (Amin Company) at a dose of 100 mg every 12 hours. Yes - There is a plan to make this available What will be shared: After defending the dissertation and approval by Ahwaz University of Medical Sciences, the collected data will be fully available (after identifying the participants) to researchers and patients. When: Access period starts 6 months after the results are published To whom: If requested, the results will be available to other researchers working in academic and scientific institutions. Conditions: The information of this trial will be provided to researchers and patients with the aim of improving the quality of life of patients with multiple sclerosis. Where to obtain: Receiving documents will be possible by sending an email to the person in charge of the update. How to obtain: Documents will be emailed over a 15-day period. Comments:
public Fatemeh Ghasemi
Farvardin Blvd., Golestan Hospital, Neurology Department
Ahvaz Iran (Islamic Republic of) 3311861357 +98 61 3374 3012 fatemeh.ghasemi@gmail.com Ahvaz University of Medical Sciences scientific Fatemeh Ghasemi
Farvardin Blvd., Golestan Hospital, Neurology Department
Ahvaz Iran (Islamic Republic of) 3311861357 +98 61 3374 3012 fatemeh.ghasemi@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Patients with definitive diagnosis of MS aged 18 to 50 years Be in the offensive phase (at least one month after the attack) Disability rate according to EDSS criteria is between 1 to 5.5. Fatigue is 4 or higher according to the FSS criteria. If interferon is used to treat multiple sclerosis, at least 6 months have passed since the start of this drug. 18 years 50 years Both History of corticosteroid use during the month before treatment Taking supplements or drugs with antioxidant properties such as vitamins E and C, zinc, melatonin Taking medications that cause fatigue and drowsiness (such as benzodiazepines, tricyclic antidepressants,sedatives, anticonvulsants) Taking stimulant drugs, amantadine, dopaminergic drugs Pregnancy and lactation History of NAC allergy or any side effects Existence of depression (according to Beck questionnaire) Accompanying medical conditions that can cause fatigue, such as: sleep disorders, heart failure, anemia, hypothyroidism and .... G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: The first group will be treated with N-acetylcysteine tablets (Exir Company) at a dose of 600 mg every 12 hours. Intervention group: The second group will receive Amantadine Capsules, brand Amorel (Amin Company) at a dose of 100 mg every 12 hours. Fatigue. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: Fatigue questionnaire according to Fatigue severity scale. Degree of disability. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: Expanded Disability Status Scale. Quality of Life. Timepoint: Before the intervention and 6 weeks after the intervention. Method of measurement: Multiple Sclerosis Quality of Life-54 Questionnaire. Vice Chancellor for Research and Technology, Ahvaz Jundishapur University of Medical Sciences Approved 2020-12-23 Ethics ComEthics Committee of Ahwaz University of Medical Sciences Farvardin St., Ahvaz, Golestan Hospital Ahwaz Khouzestan Iran (Islamic Republic of)