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IRCT20140804018677N14 IRCT 2022-03-12 Shahid Beheshti University of Medical Sciences Effect of nano crocin on cognition among MS patients 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 2022-03-01 anticipated 58 Complete https://irct.ir/trial/61965 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. N/A Multiple sclerosis. Intervention 1: Intervention group: The duration of intervention in this clinical trial will be 12 weeks. People receiving nanocrocin supplements will receive 5.74 mg of crocin loaded on selenium nanoparticles daily in the form of two supplements at a dose of 2.87 mg. Intervention 2: Control group: The duration of intervention for this group will be 12 weeks. Control group will receive placebo capsules with an equal amount of 5.74 mg of cornstarch powder in the form of two 2.87 mg daily. Yes - There is a plan to make this available What will be shared: All data would be available to public When: Starting 6 months after publication To whom: To all Conditions: No other critaria Where to obtain: Email to soodehrazeghi@gmail.com How to obtain: Sending email to me Comments:
public Nasim Rezaeimanesh
Hafezi Avenue, Farahzadi Blvd
Tehran Iran (Islamic Republic of) 1981619573 22077425 rezaeimaneshnasim@gmail.com Shahid Beheshti University of Medical Sciences scientific Soodeh Razeghi Jahromi
Hafezi Avenue, Farahzadi Blvd
Tehran Iran (Islamic Republic of) 1981619573 22077425 soodehrazeghi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The desire of the person to participate in the study Definite dagnosis of relapsing-remitting MS based on the 2017 McDonald Diagnostic Criteria Age range 55-18 years EDSS less than 5.5 Education higher than diploma More than a month has passed since the last injection of corticosteroids (pulse therapy) More than a month has passed since the last recurrence of the disease 18 years 55 years Both Having a neurological disease other than MS Pregnancy or breastfeeding Suffering from chronic gastrointestinal, liver, kidney, heart, respiratory and cancer diseases Being on a special diet Suffering from severe psychological disorders such as major depression History of allergies to saffron or its compounds G35 Multiple sclerosis Rehabilitation Placebo Intervention group: The duration of intervention in this clinical trial will be 12 weeks. People receiving nanocrocin supplements will receive 5.74 mg of crocin loaded on selenium nanoparticles daily in the form of two supplements at a dose of 2.87 mg. Control group: The duration of intervention for this group will be 12 weeks. Control group will receive placebo capsules with an equal amount of 5.74 mg of cornstarch powder in the form of two 2.87 mg daily. Cognition performance. Timepoint: At the beginning of study and the end of 12th week. Method of measurement: BICAMS test. Plasma total antioxidant capacity. Timepoint: At the beginning of study and the end of 12th week. Method of measurement: Blood test. Plasma malondialdehyde. Timepoint: At the beginning of study and the end of 12th week. Method of measurement: Blood test. Glutathione reductase activity. Timepoint: At the beginning of study and the end of 12th week. Method of measurement: blood test. Shahid Beheshti University of Medical Sciences Approved 2022-02-14 National Nutrition and Food Technology Research Institute Hafezi Avenue, Farahzadi Blvd Tehran Tehran Iran (Islamic Republic of)