Effect of nano formulation of saffron crocin on depression symptoms and cognitive impairment in patients with multiple sclerosis

evaluating the effect of nano formulation of saffron crocin on depression symptoms and cognitive impairment in patients with multiple sclerosis

A randomized, double-blind, placebo-controlled clinical trial with two parallel 20-member groups aiming at investigating the effect of saffron nano-crocin in improving symptoms of depression and cognitive impairment on 40 relapse remission multiple sclerosis patients

40 patients with confirmed diagnosis of RRMS by a neurologist and based on McDonalds criteria and with EDSS lower than 5.5 in addition to mild to moderate depression based on Beck Depression Inventory (BDI-II) (score 11 to 20) and other criteria of the study will be recruited in this study. These patients will be allocated to two groups (A or B) randomly using Blocked Randomization method. The intervention group will receive two nano-crocin capsules which contain 0.27 mg of nano-crocin every day for 12 weeks and placebo group will receive two capsules of placebo with the same smell and taste as nano-crocin during this period. Both patients and researchers won’t be aware of the treatments patients receiving in this study. General information of the patients and their activities will be asked by researchers at the beginning of the study using general information questionnaire and the General Physical Activity Questionnaire (GPAQ). At the beginning of the study, the sixth week and the end of the study, researchers will calculate patient’s depression score and cognition status using Beck Depression Inventory and MACFIMS test, respectively. At the beginning and at the end of the study, 5cc blood sample will be taken for biochemical examinations. At the sixth week of the study and at the end of the study the researchers will gather empty bottle of nano-crocin and placebo from the patients. patients will be removed from the study if they didn’t take more than 10% of the pills. We will ask all participants to keep up their routine medical treatment and normal diet without any change during the study. The efficacy of the intervention will be assessed using changes in depression severity and cognition status of RRMS patients

Diagnosis of relapse remission multiple sclerosis, mild to moderate depression, aged between 18 to 60 years and EDSS lower than 5.5

20 relapse remission multiple sclerosis patients in nano-crocin 27 mg group 20 relapse remission multiple sclerosis patients in placebo group

Changes in Minimal Assessment of Cognitive Function in MS (MACFIMS) total score

Due to double-blind nature of this trial, from the beginning of the study, A and B codes are available to researchers to recruit the using patients using Block Randomization (10 4-block).

Participants, main investigators and health care personnel responsible for patient care and the researchers who collect data and evaluate the outcome are being blinded to study groups, and only the producers of nanochocin are aware of the codes of the two study groups. Finally, after collecting the data, they unseal the codes for researchers, the statistical analyst, and those who prepare the manuscript.