Investigating the effect of nano formulation of crocin from saffron in comparison with placebo on cognitive function, plasma level of total antioxidant capacity, malondialdehyde and glutathione reductase in plasma of patients with relapsing-remitting multiple sclerosis: A randomized triple blinded clinical trial

Investigating the effect of nano formulation of crocin from saffron on cognitive function, plasma level of total antioxidant capacity,malondialdehyde and glutathione reductase in patients with relapsing-remitting multiple sclerosis

Clinical trial with placebo control group, with parallel groups, triple blinded, randomized, on 58 MS patients, randomization with blocks of size 4 using software

The place of the study: MS Research Center in Sina Hospital in Tehran; Population: relapsing remitting MS patients; type of blinding: triple blinded; blinding, randomization and preparation of supplement cans will be done by a trained person outside the study until participants, researchers and analyzer remain blind until the end of the analysis.

Inclusion criteria:the desire of the person to participate in the study; Definitive patients with RRMS based on the 2017 McDonald Diagnostic Criteria who are on file at Sina Hospital; Age 55-18, EDSS less than 5.5. Non inclusion criteria: having a neurological disease other than MS; pregnancy or breastfeeding; suffering from chronic gastrointestinal, liver, kidney, heart, respiratory and cancer; being on a diet for any reason; suffering from severe psychological disorders such as major depression; history of allergies to saffron or its compounds

Intervention group: Nanocrocin supplement, 5.74 mg of crocin loaded on selenium nanoparticles in the form of two supplements with a dose of 2.87 mg daily for 12 weeks. Control group: placebo supplement, 5.74 mg of corn starch powder in the form of two supplements with a dose of 2.87 mg daily for 12 weeks.

Cognitive function, Plasma total antioxidant capacity, Malondialdehyde and Glutathione reductase activity

Participants in the study are selected by convenience sampling method. Patients are classified according to age and gender, and each person will be placed in a group receiving nanocrocin supplementation or placebo using 1:1, quadruple random blocks. Quadruple blocks are randomly designed through software such as ...... (ABAB), (BBAB), (AABB), (ABBA), (BAAB). Assigning A or B to the supplement or placebo group will be done by someone outside the research so that the researchers remain blind. According to the list of randomly prepared quadruple blocks, a trained person outside the research team is responsible for randomly assigning patients. After each patient enters, according to the 15 quadruple blocks prepared in the first stage, each patient is randomly assigned to group A or B. Assignment process will be done consecutively until the sampling is completed.

This study will be a three-blind clinical trial, so participants, researchers, neurologists, and data analysts will be unaware that each patient is receiving a nanocrocin supplement or placebo. In this method, one of the letters A or B will be assigned to each group, and for blindness, this will be done by the manufacturer of the supplement and placebo, and therefore we will not know the details of the groups until the end of the announcement of the results.

All data would be available to public

Starting 6 months after publication

To all

No other critaria

Email to soodehrazeghi@gmail.com

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