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IRCT20240124060794N1 IRCT 2024-02-04 Esfahan University of Medical Sciences The effect of spirulina supplementation on MS Investigating the effect of spirulina algae supplement on the quality of life, speed of nerve pulse transmission and antioxidant status of patients with progressive-recovery multiple sclerosis. 2024-04-18 anticipated 80 Complete https://irct.ir/trial/75258 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: Evaluation of the improvement of the transmission of nerve messages by measuring the visual evoked potential, following supplementation with spirulina, Randomization description: In this study, the random sequence will be determined using the simple randomization method using www.sealedenvelope.com. Based on the sample size, people will be placed in two intervention and control groups with a specific code and following the concealment process. Each patient will be assigned a unique code. The specific code will be determined by a third person, and the researcher and the participant do not know to which person each code will be assigned and in which group, Blinding description: The drug and placebo are provided to both groups in completely similar containers without name labels, which are prepared in the same color and smell and coded based on random allocation by the project partner, so none of the patients and the researcher were aware of the assigned treatment and until the end The study will not be informed The random allocation list of patients will be in the sole possession of an individual outside the plan. In order to hide the random allocation process, random codes are written on the paper label without a specific order and framework, which is the identification number of the relevant treatment and only a person outside the plan will be aware of the relevant code. The labels will be stuck on the medicine packages in the order of the randomization list. Medicine packages will be arranged in the order of the randomization list inside the box. When a patient's eligibility is determined, the researcher will provide the patient with a treatment plan. 3 Multiple sclerosis. Intervention 1: Intervention group: spirulina algae supplement, 500 mg capsules, twice a day for three months, consumption after the main meal, Spiro Company (Bushehr-Iran). Intervention 2: Control group: Placebo capsules containing corn starch, twice a day for three months, consumed after the main meal, Spiro Company (Bushehr-Iran). No - There is not a plan to make this available Justification or reason for not sharing IPD is Due to the commitment to the confidentiality of the personal information of the people in the consent form, there is no plan to publish it.
public Mohammad Hasan Entezari
Hezar Jerib Avenue, Isfahan
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3172 entezari@hlth.mui.ac.ir Esfahan University of Medical Sciences scientific Mohammad Hasan Entezari
Hezar Jerib Avenue, Isfahan
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 3172 entezari@hlth.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with MS of RRMS type Age of patients 18-50 years Receiving immunosuppressive drugs for at least three months Not taking multivitamin supplements (except vitamin D) at least 3 months before participating in the study Having an Extended Disability Status Scale (EDSS) between 0 and 6 18 years 50 years Both Pregnancy Presentation of acute forms of liver and biliary system disease and pancreatic disease History of viral diseases Chronic renal or cardiovascular disease and diseases where oxidative stress is considered as their etiology Obese patients (body mass index (BMI) ≥ 30 kg/m2), malnourished patients (BMI < 18.5 kg/m2) Dependence on drugs, smoking or alcohol Not taking anticoagulants Breastfeeding Hospitalized Autoimmune diseases that affect the Th1/Th2 balance Asthma Diseases in which oxidative stress is proposed as their etiology G35 Multiple sclerosis Rehabilitation N/A Intervention group: spirulina algae supplement, 500 mg capsules, twice a day for three months, consumption after the main meal, Spiro Company (Bushehr-Iran). Control group: Placebo capsules containing corn starch, twice a day for three months, consumed after the main meal, Spiro Company (Bushehr-Iran). Investigating antioxidant status. Timepoint: Before and after supplementation. Method of measurement: Biochemical kit for measurement of antioxidant level. Investigating the quality of life and work. Timepoint: Before and after supplementation. Method of measurement: Quality of life questionnaire. Investigating the speed of nerve transmission. Timepoint: Before and after supplementation. Method of measurement: Skin electrode. Investigating the inflammation status. Timepoint: Before and after supplementation. Method of measurement: IL-1 and IL-6 measurement by ELISA. Esfahan University of Medical Sciences Approved 2024-01-20 Ethics committee of Esfahan University of Medical Sciences Hezar Jerib Avenue, Isfahan Esfahan Isfehan Iran (Islamic Republic of)