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Study aim: Comparison of the effect of liposomal form of pistachio kernel oil and placebo on inflammatory and anti-inflammatory agents and their receptors in peripheral blood mononuclear cells and the severity of clinical symptoms in women with multiple sclerosis Design: Clinical trial with control group, double-blind, simple randomized, phase 3 on 500 MS patients. Excel software rand function is used for randomization Settings and conduct: This clinical trial will be performed on MS patients referred to Ali Ibn Abitaleb Hospital in Rafsanjan. 500 MS patients will be included in the study and will be divided into intervention and control groups and will be treated and monitored for 24 weeks with the liposomal form of 10% pistachio kernel oil or placebo. In this study, blinding is also performed. Participants, lead researcher, health care staff responsible for patient care, data collection and outcome assessors, data safety and monitoring committee, and drafters, will keep blind. Participants/Inclusion and exclusion criteria: Inclusion criteria: Women aged 18 to 51 years with definitive diagnosis of multiple sclerosis and descriptive measurement of disability between 1 to 3. Exclusion criteria: using corticosteroids during study, pregnancy and lactation, autoimmune diseases, other neurological diseases. Intervention groups: Nanoliposome intervention group: This group is given the liposomal form of 10% pistachio kernel oil orally to MS patients for 24 weeks. Control group: This group of placebo is given orally to MS patients for 24 weeks. Main outcome variables: Concentration of inflammatory and anti-inflammatory factors; Relative expression of receptors genes of inflammatory and anti-inflammatory agents; The length and severity of the disease
IRCTID: IRCT20201219049765N1
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