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IRCT20240609062052N3 IRCT 2024-08-11 Khomein Faculty of Medical Sciences Investigating the effect of Femi Locket on the fatigue of multiple sclerosis patients Investigating the effect of Femi Locket on the fatigue of multiple sclerosis patients referring to the clinics of Arak University of Medical Sciences 2024-07-13 anticipated 30 Complete https://irct.ir/trial/77712 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The names of all patients will be written completely randomly from top to bottom after sampling the required amount (30 people) using the available (easy) sampling method; Then, from the top, we assign number 1 to the first person, then 2 to... the last person to whom we assign the number 30. Then numbers 1 to 15 will be assigned to the control group and numbers 16 to 30 to the intervention group, Blinding description: In this study, only the patients and the project manager who is supposed to perform the intervention on the patients; They will be blind. In this way, the empty capsule will be prepared exactly the same as the Familact capsule, and 30 glasses will be prepared for the drugs. According to the randomization, glasses 1 to 15 will contain 3 empty capsules each and glasses number 16 to 30 will contain 3 Familact capsules each. In this way, both the project manager and the patient will not know whether the capsule they receive is Familact or a placebo. 2-3 Multiple sclerosis. Intervention 1: Control group: Placebo Group. Intervention 2: Intervention group: Familact Group. Yes - There is a plan to make this available What will be shared: All information and data will be shared after de-identifying people. When: Access will start 1 month after the results are published. To whom: All people related to medical and health matters Conditions: The use of data will only be subject to mention of the source of the study and the authors. It is definitely necessary to obtain permission from the authors and researchers of the study. Where to obtain: With this E-Mail:Mahdisafarabadi@gmail.com How to obtain: After submitting the request and explaining the reason for the request, Dr. Safarabadi, the scientific accountability officer, will review the request and finally, within 72 hours after the request, the result will be informed to the requester. Comments:
public Mahdi Safarabadi
Quds Avenue
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 mahdisafarabadi@gmail.com Khomein Faculty of Medical Sciences scientific Mahdi Safarabadi
Quds Avenue
Khomein Iran (Islamic Republic of) 3881743364 +98 86 4622 4142 mahdisafarabadi@gmail.com Khomein Faculty of Medical Sciences Iran (Islamic Republic of) Having a history of multiple sclerosis for 6 months Neurological examination and brain CT scan and ruling out brain tumors and space-occupying lesions Absence of mental illnesses including depression and absence of psychiatric problems and nervous headaches Absence of accompanying diseases that cause fatigue, including thyroid diseases and anemia no limit no limit Both Presence of sensitivity to Femilact G35 Multiple sclerosis Placebo Treatment - Drugs Control group: Placebo Group Intervention group: Familact Group Fatigue. Timepoint: Before the start of the intervention, 30 and 60 days after the start of the intervention. Method of measurement: "Fatigue Severity Scale" (FSS) standard checklist. Khomein Faculty of Medical Sciences Approved 2024-05-28 Ethics Committee of Khomein Faculty of Medical Sciences Quds Avenue Khomein Markazi Iran (Islamic Republic of)