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IRCT20120227009157N7 IRCT 2018-02-16 Tehran University of Medical Sciences Effect of nano formulation of saffron crocin in patients with multiple sclerosis Effect of nano formulation of saffron crocin on depression symptoms and cognitive impairment in patients with multiple sclerosis 2018-04-22 anticipated 40 Complete https://irct.ir/trial/29602 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: 40 patients with confirmed diagnosis of RRMS by a neurologist and based on McDonalds criteria and with EDSS lower than 5.5 and with mild to borderline depression based on Beck Depression Inventory (BDI-II) (score 11 to 20) and other criteria of the study will be entered to this study. These patients will be divided to two groups randomly by Blocked Randomization method. 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 by our 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 by Beck Depression Inventory. At the beginning and at the end of the study 5cc of patients blood 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 placelo from the patients. parients will be removed from the study if they didn’t take more than 10% of the pills.We will ask from 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 Beck Depression Inventory in addition to measuring changes in depression severity of RRMS patients, Randomization description: 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), Blinding description: 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. 0 (exploratory trials) multiple sclerosis. Intervention 1: Intervention group: intervention group will receive two nano-crocin capsules which contain 0.27 mg of nano-crocin every day for 12 weeks. Intervention 2: Control group: placebo group will receive two capsules of placebo with the same smell and taste as nano-crocin during 12-week period. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is there is no further information
public Dr Soodeh Razeghi Jahromi
West Arghavan, Farahzadi BLV, Shahrak Gharb
Tehran Iran (Islamic Republic of) 4741-19395 +98 21 22357 razeghi@sina.tums.ac.ir Shahid Beheshti University of Medical Sciences scientific Dr. Soodeh Razeghi Jahromi
West Arghavan, Farahzadi BLV, Shahrak Gharb
Tehran Iran (Islamic Republic of) 4741-19395 +98 21 22357 razeghi@sina.tums.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) • Willingness to participate in the study• Age range between 18 to 60 years old Diagnosis of relapse remission multiple sclerosis according to the McDonalds 2010 criteria and taking B-interferon as treatment Diagnosis of mild to moderate according to DSM V(Diagnostic and Statistical Manual of Mental Disorders, 5th edition) by a neurologist and Beck Depression Inventory (BDI-II) (score from 11 to 20) EDSS lower than 5.5 18 years 60 years Both Pregnancy (or having a planned pregnancy) or Lactation Allergy or sensibility to the drugs at the beginning of their treatments History of allergy or sensibility to Saffron or its components Receiving IVIG during the last six months of treatment Increase of liver enzymes three times more than normal value Stop taking drugs for more than forth months G35 Multiple sclerosis Prevention Placebo Intervention group: intervention group will receive two nano-crocin capsules which contain 0.27 mg of nano-crocin every day for 12 weeks Control group: placebo group will receive two capsules of placebo with the same smell and taste as nano-crocin during 12-week period. Minimal Assessment of Cognitive Function in MS (MACFIMS) total score. Timepoint: baseline. Method of measurement: after 12-week intervention. Total score of beck's depression inventory. Timepoint: baseline. Method of measurement: after 12-week intervention. Tehran University of Medical Sciences Approved 2018-01-22 tehran university of medical sciences ghods avenue, tehran university of medical sciences tehran Tehran Iran (Islamic Republic of)