]>
IRCT20221109056447N1 IRCT 2023-11-29 Oroumia University of Medical Sciences Investigating the effect of crocin on patients with multiple sclerosis 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 2023-11-22 anticipated 40 Complete https://irct.ir/trial/66753 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 2 MS or multiple sclerosis. Intervention 1: Intervention group: who receive one 15 mg crocin tablet daily for two months. According to the diagnosis of a specialist doctor, for the treatment of anxiety and depression in these patients, SSRI drugs such as fluoxetine, citalopram and sertraline are used as standard drugs. Intervention 2: Control group: Placebo recipients (placebo), who receive one placebo tablets daily for two months.According to the diagnosis of a specialist doctor, for the treatment of anxiety and depression in these patients, SSRI drugs such as fluoxetine, citalopram and sertraline are used as standard drugs. 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 After the project, the information will be published in the form of an article.
public Dr. Samaneh Sepahi
Orjhans Street, Resalat Blvd
Urmia Iran (Islamic Republic of) 5714783734 009832234897 sepahi.s@umsu.ac.ir Oroumia University of Medical Sciences scientific Dr. Samaneh Sepahi
Orjhans Street, Resalat Blvd
Urmia Iran (Islamic Republic of) 5714783734 +98 44 3223 4897 sepahi.s@umsu.ac.ir Oroumia University of Medical Sciences Iran (Islamic Republic of) Definitive diagnosis of MS with neurologist visit, based on the McDonald diagnostic criteria. Patients with MS aged 18 to 50 (relapsing-remitting MS or RRMS). No relapse attacks one month before t the study. Obtaining 0 to 5.5 points based on the disability scale. Patients who take first and second line drugs in oral and injectable form (dimethyl fumarate, Resigen, Betaferon, Triflunomide, Fingolimido Sinomer). According to the specialist doctor, SSRI drugs such as fluoxetine, citalopram and sertraline are used as standard drugs for the treatment of anxiety and depression in these patients. Expression of willingness to participate in the study. 18 years 50 years Both Suffering from other diseases such as (chronic diseases, heart failure, glands, breathing, liver, kidney, skeletal-muscular) and mental diseases and severe depression. Addiction to alcohol, drugs and psychedelics. Allergy to saffron. Pregnancy and breastfeeding. The presence of severe infection and inflammation, varicose veins, active thrombosis, damage to organs such as fractures. Motor disability score higher than 6 G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: who receive one 15 mg crocin tablet daily for two months. According to the diagnosis of a specialist doctor, for the treatment of anxiety and depression in these patients, SSRI drugs such as fluoxetine, citalopram and sertraline are used as standard drugs. Control group: Placebo recipients (placebo), who receive one placebo tablets daily for two months.According to the diagnosis of a specialist doctor, for the treatment of anxiety and depression in these patients, SSRI drugs such as fluoxetine, citalopram and sertraline are used as standard drugs The effect of crocin on the anxiety intensity. Timepoint: Measuring anxiety intensity at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Beck's anxiety questionnaire. The effect of crocin on the depression Intensity. Timepoint: Measuring depression severity at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Beck's depression questionnaire. Effect of crocin on quality of life. Timepoint: Measuring quality of life at the beginning of the study (before the intervention) and two months after the intervention. Method of measurement: Questionnaire of quality of life of MS patients MsQoL-54 (Multiple Sclerosis Quality of Life-54). Investigating the effect of crocin on periodic pain assessments. Timepoint: Examining periodic pain assessments at the beginning of the study (before the study) and two months after the intervention. Method of measurement: Examining periodic pain assessments from the McGill Pain Questionnaire (MPQ). Oroumia University of Medical Sciences Approved 2023-10-09 Ethics committee of Urmia University of Medical Science Orjhans Street, Resalat Blvd. Urmia West Azarbaijan Iran (Islamic Republic of)