The effect of ginseng in fatigue related to neuromyelitis optica spectrum disorder: a double-blind randomized clinical trial

evaluating the effect of gensing on fatigue of patients with neuromyelitis optica in comparison with placebo group

Clinical trial with control group, with parallel groups, double-blind, randomized, phase 3 on 58 patients. Excel software rand function was used for randomization.

In this study, which is designed as a double-blind randomized clinical trial, all definite cases of neuromyelitis optica are examined based on the 2015 diagnostic criteria that refer to the neuromyelitis optica clinic of Sina Hospital from 2019 to 2020, and After obtaining the written consent of the study participants, patients are randomly assigned to the intervention and placebo groups. Patients 'fatigue at the time of enrollment will be calculated according to the Fatigue Severity Scale criteria and patients' disability at the time of enrollment will be calculated according to the Expanded disability status scale criterion.

Inclusion criteria: 2015 diagnostic criteria of neuromyelitis optica exclusion criteria: pregnancy, Concomitant use of anti-fatigue medications, Having concomitant diseases that can affect fatigue

In the intervention group, patients will receive ginseng with a dose of 250 mg twice a day for 3 months. In the control group, placebo with the same appearance as ginseng will be given twice a day for 3 months. Medication and placebo are made by "Gol Daroo" company.

severity of fatigue

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.

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.