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IRCT20210707051810N1 IRCT 2021-09-01 Tehran University of Medical Sciences Evaluation of the effect of Trazodone in hospitalized patients with MS Comparison of the effectiveness of Trazodone with placebo in preventing acute sleep disturbances caused by corticosteroid pulse in hospitalized patients with MS 2021-09-01 anticipated 48 Complete https://irct.ir/trial/57418 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Randomization with quadruple blocks based on a table of random numbers, Blinding description: The patient, the treating physician, and the person monitoring the patient are blind to the intervention. The study is double blind. The main researcher in the study encodes the drugs in groups a and b, and he is aware of the drug and the placebo of the cans, but is blind about which patient receives which drug package code. The researcher who gives patients medication and perform evaluation tests, the data analyzer, and also the patients are blind to the study groups. It most be considered that the drug and placebo are completely similar in appearance. 3 MS. Intervention 1: Intervention group: Patients in this group use 50 mg trazodone tablets of Tehran Shimi Company every night at 9 o'clock from the first day of hospitalization until the day of discharge. Intervention 2: Control group: Patients in the control group receive a placebo product made by Tehran Shimi Company every night at 9 o'clock from the first day of hospitalization until the day of discharge. No - There is not a plan to make this available Justification or reason for not sharing IPD is According to the items mentioned in the informed consent, patients' information will not be disseminated.
public Hooshyar Honarmand
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
Tehran Iran (Islamic Republic of) 1136746911 +98 21 8832 2025 Hooshyar1978@gmail.com Tehran University of Medical Sciences scientific Hooshyar Honarmand
Sina Hospital, Imam Khomeini St, Hasan Abad Sq
تهران Iran (Islamic Republic of) 1136746911 +98 21 8832 2025 Hooshyar1978@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with relapsing-remitting MS who are between 18 and 65 years old and hospitalized for treatment with corticosteroid pulse. Hospitalized patients who are candidates for corticosteroid pulse at the rate of 1 gram per day for 3 to 5 days. 18 years 65 years Both Receiving other sleeping pills such as Barbiturates, Benzodiazepines, Doxepin, Melatonin and Zolpidem in the last 2 weeks Having Primary Insomnia Trazodone use in the last 2 weeks Taking Monoamine oxidase inhibitor drugs in the last 2 weeks History of hypersensitivity reaction to Trazodone or any components in the formulation Severe chronic renal failure (Creatinine clearance less than 30 ml/min) and liver failure Pregnancy and lactation Patients receiving concomitant Intravenous immunoglobulin or plasma exchange other than Corticosteroid pulse G35 Multiple sclerosis Prevention Placebo Intervention group: Patients in this group use 50 mg trazodone tablets of Tehran Shimi Company every night at 9 o'clock from the first day of hospitalization until the day of discharge. Control group: Patients in the control group receive a placebo product made by Tehran Shimi Company every night at 9 o'clock from the first day of hospitalization until the day of discharge. Insomnia score in Verran and Snyder-Halpern questionnaire (VSH). Timepoint: Every day from the first day of hospitalization until the day of discharge (A total of 3 to 5 days). Method of measurement: VSH questionnaire. Tehran University of Medical Sciences Approved 2021-06-01 Research Ethics Committee of Tehran University of Medical Sciences 16 Azar Street Tehran Tehran Iran (Islamic Republic of)