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.

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.

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 80 patients. The rand function of Excel software was used for randomization.

The present study will be a double-blind clinical trial in Isfahan city on patients with progressive-recovery MS in two intervention and control groups with random blinding method. Personal, demographic, anthropometric, economic-social information, quality of life and work and food intake will be evaluated by questionnaire. In order to measure the speed of nerve message transmission, visual induction potential test will be used. Changes in the antioxidant level of the body will be checked by biochemical kits. The amount of spirulina supplement (intervention) and placebo (control) will be 1000 mg for 12 weeks.

Criteria for entering the study Patients with MS of RRMS type Age of patients 18-50 years Having an Extended Disability Status Scale (EDSS) between 0 and 6 Criteria for not entering the study: Pregnant, lactating and hospitalized participants History of viral diseases, asthma, and other autoimmune diseases that affect the Th1/Th2 balance obese patients (body mass index (BMI) ≥ 30 kg/m2), malnourished patients (BMI < 18.5 kg/m2) Not taking anticoagulants

The intervention group includes patients with progressive-relapsing MS with an EDSS score of 0-6 who receive spirulina supplements. The control group includes patients with progressive-remitting MS with an EDSS score of 0-6 who receive a placebo.

Improving patients' quality of life, antioxidant status and speed of nerve message transmission

Evaluation of interleukins IL-1 and IL-6 in the patients' serum has been added, which does not affect the intervention process and is only considered an additional evaluation.

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.

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.

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.