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IRCT20171030037093N34 IRCT 2020-03-28 Esfahan University of Medical Sciences The effect of cocoa powder on fatigue in multiple sclerosis patients Investigation of the effect of cocoa powder on fatigue severity in patients with multiple sclerosis(MS) in comparison with placebo effect 2020-03-30 anticipated 60 Complete https://irct.ir/trial/46493 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Patients in the study were randomly assigned to either A or B groups using computer software, Blinding description: At first the drug powder and placebo optionally into groups A and B are packed without the knowledge of a physician, patient, or analyzer (note that only the first person knows that package A is the drug or placebo). The software is divided into recipient groups A and recipient B, which will be written in the form A or B.After completing the design and final analysis, the packaging person announces that A B Which powder (drug or placebo) each had. According to this physician, the patient and the analyzer were unaware of the groups until after the data was analyzed. 2 Multiple sclerosis. Intervention 1: Intervention group: The drug will be administered in the form of 12.5 grams of cocoa powder after dissolving in a glass of water half an hour before or one hour after meals. Intervention 2: Control group: receive placebo. Each placebo pack contains 2.5 grams of cocoa powder (much less than the effective and therapeutic dose of cocoa) that can be used in 200 cc of boiling water or milk. 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 I will decide until finishing the study
public Iman Adibi
Kashani Hospital
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 7539 i.adibi@gmail.com Esfahan University of Medical Sciences scientific Iman Adibi
Kashani Hospital
Isfahan Iran (Islamic Republic of) 7346181746 +98 31 3792 7539 i.adibi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the study MS with Relapsing remitting form Less than 10 years have passed since their diagnosis Age between 20 and 50 years Have a Fatigue severity scale above 4. The EDSS score is below 6 Have a recent anemia and hypothyroid rejection test in one month 20 years 50 years Both Have recurrent in the past 3 months The disease involves the CNS except migraine They have acute febrile illness Have systemic autoimmune disease Based on Beck Depression Inventory moderate or severe (Questionnaire score above 20) Currently taking neurotoxic drugs including: antipsychotic agents, monoamine oxidase inhibitors, benzodiazepines, tricyclic antidepressant drugs, anticonvulsants, beta blockers and barbiturates G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: The drug will be administered in the form of 12.5 grams of cocoa powder after dissolving in a glass of water half an hour before or one hour after meals. Control group: receive placebo. Each placebo pack contains 2.5 grams of cocoa powder (much less than the effective and therapeutic dose of cocoa) that can be used in 200 cc of boiling water or milk. Fatigue. Timepoint: Before and after the study. Method of measurement: With MFIS and FSS questionnaires. Esfahan University of Medical Sciences Approved 2019-11-26 Ethics Committee of Isfahan University of Medical Sciences Isfahn University of Medical Sciences, Hezar Jerib Avenue, Isfahan Isfahan Isfehan Iran (Islamic Republic of)