Investigating the effect of crocin on quality life, anxiety and depression in patients with multiple sclerosis in a placebo-controlled randomized double blind clinical trial

Determining the effectiveness of crocin on depression, anxiety and quality of life in patients with MS patients.

This study will be a parallel triple-blind clinical trial, randomized in a simple block method in phases 2 and 3 on 40 patients with MS.

This study will be conducted in the neurology department of Imam Khomeini Hospital. After the introduction of the patient by a specialist doctor and according to the inclusion criteria, tablets are randomly provided to the patients. At first visit, the informed consent form is signed by the patient. The distribution of tablets is random, three-blind, and the specialist doctor and the patient will not know how to divide the tablets.

Inclusion criteria: definitive diagnosis of MS disease with a neurologist visit, and based on McDonald's criteria, patients with MS aged 18 up to 50 (recurrence-recovery or RRMS), not having relapse attacks one month before the study, expressing willingness to participate in the study, scoring 0 to 5.5 based on the Expanded Disability Status Scale (EDSS), patients with MS who use first and second line drugs in oral and injectable form, use of anxiety and depression category of drugs SSRIs are used. Exclusion Criteria:suffering from other diseases such as (chronic diseases, skeletal-muscular) and mental diseases and severe depression, addiction to alcohol, drugs and psychotropic substances, history of allergy to saffron, pregnancy and breastfeeding, presence of infection and severe inflammation, motor disability score higher than 6.

Intervention group: who receive one 15 mg crocin tablet daily for two months. Control group: Placebo recipients (placebo), who receive one placebo tablet daily for two months.

Primary outcomes: anxiety, depression and quality of life.

Randomization will be in a simple method with the Excel software; numbers (or codes) will be created in Excel using the Random Number Generation option. These numbers will be prepared according to the sample size (number of patients) and according to the number of studied groups, which are two groups in this study, and as a result the numbers will be prepared in two column. First column of the random number table will be assigned to crocin group and the second one to placebo. The codes will be written on a piece of paper and put into an opaque envelope. The envelopes will be sealed and placed sequentially in a box and kept by researcher and physician. Envelopes and their code will be assigned sequentially to eligible participants in order of their arrival time. Thus, each code is not known until the results are analyzed.

Crocin and placebo tablets are coded in dark boxes by a third party (the patient and the specialist doctor have no knowledge of how the pills are distributed) and are randomly given to the patient.