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IRCT20230706058689N1 IRCT 2023-12-29 Arak University of Medical Sciences The effect of phoenix Dactylifera supplementary on fatigue in patients with multiple sclerosis Multiple sclerosis (MS) The effect of phoenix Dactylifera supplementary on fatigue in patients with multiple sclerosis 2023-12-30 anticipated 50 Complete https://irct.ir/trial/74234 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Randomization description: Block randomization method will be used in this study. Also, the unit of randomization is individual, and patients with multiple sclerosis who meet the study entry criteria based on their willingness to participate in the research, were included in the study non-randomly and then randomly by block randomization method (block of four) in two groups A. and B are assigned. In this study, due to having the volume of four blocks, six different states will be imagined for the blocks, which are: AABB, ABAB, ABBA, BBAA, BABA, BAAB. Different states of blocks will be written on cardboard cards of the same size and color. According to the sample size (50 patients) and six types of blocks, the number of cards 9 times randomly by re-replacing the selection and order of blocks will determine the order of placement of patients in groups A (control) and B (intervention), Blinding description: In this study, doctors, patients, and statistical analysts are not aware of the allocation of patients in the intervention and control groups. In this study, patients in the test group will only receive capsules containing starch, and patients in the control group will also receive capsules containing starch. Starch will be offered to patients in the exact same packaging and color as phoenix Dactylifera capsules due to its similarity in appearance with phoenix Dactylifera. Similarly, in order to make the statistical analyst unaware, the control and intervention groups are marked with code one and two, so that only the researcher knows about the control and intervention groups. The doctor introduces the patients to the researcher, and due to the fact that the drug under study is not among the essential drugs for the patients and does not require a doctor's prescription, the doctor does not know about the allocation of patients in the control and intervention groups. 3 Multiple sclerosis. Intervention 1: Intervention group: phoenix dactylifera (Date Palm pollen), 300 mg capsules, twice a day at 10 am and 10 pm, place of production: Tehran Faculty of Pharmacy, Medical Sciences. Intervention 2: Control group: placebo (containing starch), 300 mg capsules, twice a day at 10 am and 10 pm, place of production: Tehran Faculty of Pharmacy, Medical Sciences. 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 There is no further information
public Ali Jadidi
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3501 farnosh.ansari99@gmail.com Arak University of Medical Sciences scientific Farnosh Ansari
Second floor, Faculty of Nursing, Arak University of Medical Sciences, Basij Square
Arak Iran (Islamic Republic of) 3819693345 +98 86 3417 3501 farnosh.ansari99@gmail.com Arak University of Medical Sciences Iran (Islamic Republic of) Having a history of MS for at least 3 months (based on the information in the patient's file) Age 18 to 60 years Absence of food and drug allergy (date products) Obtaining a score of 28 or more in severe measurement (FSS) Obtaining informed consent Absence of pregnancy (pregnancy during the study period or decision to become pregnant at the beginning of the study) 18 years 60 years Both The use of antidepressants The use of other medications effective in relieving fatigue (Ritalin, Pemoline, Amantadine) G35 Multiple sclerosis Treatment - Other Placebo Intervention group: phoenix dactylifera (Date Palm pollen), 300 mg capsules, twice a day at 10 am and 10 pm, place of production: Tehran Faculty of Pharmacy, Medical Sciences Control group: placebo (containing starch), 300 mg capsules, twice a day at 10 am and 10 pm, place of production: Tehran Faculty of Pharmacy, Medical Sciences Fatigue score based on the Fatigue Severity Scale (FSS). Timepoint: Measuring the severity of fatigue at the beginning (before the start of the intervention) and 6 weeks after the start of the intervention. Method of measurement: Fatigue severity scale Questionnaire. Arak University of Medical Sciences Approved 2023-10-28 Ethics Committees of Arak University of Medical Sciences Management of Research and Medical Information, Deputy of Research and Technology, University Complex of the Prophet (pbuh), Basij Square Arak Markazi Iran (Islamic Republic of)