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IRCT20200713048095N1 IRCT 2020-08-07 Tehran University of Medical Sciences The effect of ginseng on fatigue in neuromyelitis optica spectrum disorder The effect of ginseng in fatigue related to neuromyelitis optica spectrum disorder: a double-blind randomized clinical trial 2019-03-21 anticipated 58 Complete https://irct.ir/trial/49622 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomize patients with inclusion criteria Block balanced randomization is used. Before studying, one of the person who is not a member of the research team performs the randomization process using Random generator software, and forms blocks of four for the intervention and control group. The complete cards of the blocks are given to a nurse, who is unaware of the study, in an envelope. A card is given to the patient after patient entrance to the study, Blinding description: The required number of drugs will be provided to the researcher in the research center (equal number of boxes containing the drug and the box containing the placebo), which are not distinguishable in appearance and can only be separated by special codes on the labels affixed to the drug box. Each code will belong to one patient from the beginning to the end of the study, which can be traced with the same code throughout the study period in the patient's research center. The drugs are coded by one person and then the coded drugs are sent to the centers. The person delivering the medicine to the patient does not know what the code was for the medicine or placebo. In this way, the researcher and the patient do not know whether the prescription pills are a drug or a placebo. 3 fatigue in Neuromyelitis optica spectrum disorder (NMOSD). Intervention 1: Intervention group: will receive Ginseng 250-mg oral tablets twice a day for 3 months. medication is made by "Gol Daroo" company. Intervention 2: Control group: will receive placebo resembling ginseng oral tablets twice a day for 3 months. medication is made by "Gol Daroo" company. 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 It is unknown at this time what will be done
public َAbdorreza Naser Moghadasi
Sina Hospital, Hassan abad Sq., Imam Khomeini Ave.
Tehran Iran (Islamic Republic of) 1136749986 +98 21 6634 8572 moghaddasi@sina.tums.ac.ir Tehran University of Medical Sciences scientific َAbdorreza Naser Moghadasi
Sina Hospital, Hassan abad Sq., Imam Khomeini Ave.
Tehran Iran (Islamic Republic of) 1136749986 +98 21 6634 8572 moghaddasi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 2015 diagnostic criteria for neuromyelitis optica spectrum disorder no limit no limit Both pregnancy Concomitant use of anti-fatigue medications Having concomitant diseases effecting fatigue G36.0 Neuromyelitis optica [Devic] Treatment - Drugs Placebo Intervention group: will receive Ginseng 250-mg oral tablets twice a day for 3 months. medication is made by "Gol Daroo" company. Control group: will receive placebo resembling ginseng oral tablets twice a day for 3 months. medication is made by "Gol Daroo" company. Severity of fatigue in Fatigue Severity Scale questionnaire. Timepoint: evaluation of fatigue before intervention and 90 days after administering ginseng or placebo. Method of measurement: Fatigue Severity Scale questionnaire. Tehran University of Medical Sciences Approved 2020-03-09 Ethics committee of Tehran University of Medical Sciences Central building of Tehran University of Medical sciences, Ghods st, Keshavarz blv. Tehran Tehran Iran (Islamic Republic of)