The effect of phoenix Dactylifera supplementary on fatigue in patients with multiple sclerosis

Determining the effect of phoenix Dactylifera supplement on fatigue in patients with multiple sclerosis

A clinical trial with a control group, double-blind, randomized phase 3 clinical trial on 50 patients.

The research community will consist of multiple sclerosis patients referred to the clinics of Arak University of Medical Sciences. Patients will be divided into two control and intervention groups based on the randomized method. Patients of both groups will complete demographic and fatigue severity questionnaire before the start of the study. Patients in the control group received phoenix Dactylifera supplement capsules and the intervention group received placebo capsules containing starch powder .Six weeks after the start of the intervention, the fatigue severity questionnaire will be completed by two groups.

Having a history of multiple sclerosis for at least 3 months, having an age range of 18 to 60 years, not being pregnant, not having food and drug allergies (Date products), obtaining a score of 28 or more on the Fatigue Severity Scale (FSS), Not taking anti-depressants and anti-fatigue drugs.

The intervention group in this study will receive 84 capsules of 300 mg of phoenix Dactylifera supplement and they will be told to consume them twice a day at 10:00 PM and 10:00 AM for 42 days. Similarly, the control group will be given 84 placebo capsules and they will be asked to take them twice a day at 10 pm and 10 am for 42 days.

fatigue severity questionnaire

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).

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.