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IRCT20150713023190N12 IRCT 2022-05-23 Rafsanjan University of Medical Sciences The effect of Jollab beverage on fatigue and happiness in patients with multiple sclerosis Investigation the effect of Jollab beverage on fatigue and happiness in patients with multiple sclerosis referring to the MS Association of Rafsanjan 2022-06-05 anticipated 70 Complete https://irct.ir/trial/63405 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Stratified randomization by minimization method: in this method, initially, the patients will categorize based on key variables, such as scores from fatigue severity scale and Oxford happiness questionnaires. Afterwards, from the patients who will meet the inclusion criteria, the first participant will place in the intervention or control group by coin flip, and other participants will allocate to the study group with lower total of variables. The following table is used as a randomization tool: Variables Category Intervention group Control group Happiness questionnaire score 0-29 30-58 59-87 Fatigue Severity Scale (FSS) questionnaire score 36-49 50-63. 2-3 Multiple Sclerosis. Intervention 1: Intervention group: In this group, patients will receive 45 ml of jolab beverage (including 10.5 cc rose , 15 mg saffron, 9.25 g brown sugar and 3.75 cc water) daily for 4 weeks. Intervention 2: Control group: In this group, patients will receive placebo (including 13.5 cc water, 1.5 cc rose water, 9.25 g. brown sugar and yellow food colour to create a colour similar to the Jollab) exactly like the intervention group. 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 Confidentiality of data
public Tabandeh Sadeghi
Parastar Ave
Rafsanjan Iran (Islamic Republic of) 7718796755 +98 34 3425 5900 t.b_sadeghi@yahoo.com Rafsanjan University of Medical Sciences scientific Tabandeh Sadeghi
Parastar Ave
Rafsanjan Iran (Islamic Republic of) 7718796755 009834342555900 t.b_sadeghi@yahoo.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Age between 18-60 years old Satisfaction to participate in the study Getting a score above 36 from the Fatigue Severity Scale questionnaire Satisfaction for taking Jollab beverage or placebo Confirmation of multiple sclerosis by a neurologist 18 years 60 years Both Having other neurological diseases except multiple sclerosis Allergy to medicinal plants especially saffron and rosa damascena Pregnancy Lactation G35 Multiple sclerosis Treatment - Other Treatment - Other Intervention group: In this group, patients will receive 45 ml of jolab beverage (including 10.5 cc rose , 15 mg saffron, 9.25 g brown sugar and 3.75 cc water) daily for 4 weeks. Control group: In this group, patients will receive placebo (including 13.5 cc water, 1.5 cc rose water, 9.25 g. brown sugar and yellow food colour to create a colour similar to the Jollab) exactly like the intervention group Fatigue. Timepoint: Before the intervention and 30 days after the Jollab beverage consumption. Method of measurement: Fatigue Severity Scale. Happiness. Timepoint: Before the intervention and 30 days after the Jollab beverage consumption. Method of measurement: Oxford Happiness Questionnaire. Rafsanjan University of Medical Sciences Approved 2022-04-13 Ethics Committee of Rafsanjan University of Medical Sciences Imam Ali Blvd Rafsanjan Kerman Iran (Islamic Republic of)