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IRCT20230116057135N3 IRCT 2023-06-10 Tehran University of Medical Sciences Effect of the NBS on the treatment of nosocomial infections NBS-BSI Investigating the effect of the Nutrition Bio-Shield (NBS) herbal supplement on the treatment of patients with nosocomial multi-drug resistant bloodstream infections admitted to emergency Intensive care unit. 2023-06-22 anticipated 94 Complete https://irct.ir/trial/70346 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are divided into intervention and control groups by random block method. Allocation of the samples to two groups with random permutation block design will be two treatments with blocks of four. In this way, the letter A is considered for the intervention group and the letter B is considered for the control group. Then we write all the alternating combinations of the letters A, A, B and B, which are 6 different combinations, on 6 cards in this order: AABB, ABBA, ABAB, BAAB, BABA, BBAA, then one digit from 1 to 6, we choose randomness and continue this process until the sample size reaches the quorum, Blinding description: The evaluator and statistician, nurses and patients are blind. In this study, due to examining the process of clinical changes of the patient after taking the NBS herbal supplement and preventing any possible clinical problems in the patients, the doctor is aware of the presence of each patient in each group of the present study. 3 Hospital-acquired bloodstream infections. Intervention 1: Intervention group: Patients in the intervention group, in addition to the standard treatment panel, receive Nutrition Bio-Shield (NBS) powder as follows: the amount of NBS 500 mg capsule is 4.5 g daily in three doses: 1.5 g in the morning, 1.5 g in the afternoon, and 1.5 g The night is for 14 days. Intervention 2: Control group: In addition to the standard treatment regimen, patients in the control group also receive placebo capsules that are given in the morning, noon, and night. 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 Mehrdad Mosadegh
Shafiei St., Qods St., Enghelab St., Tehran, Iran
Tehran Iran (Islamic Republic of) 9171971631 +98 935 563 3390 m-mosadegh@razi.tums.ac.ir Tehran University of Medical Sciences scientific Mehrdad Mosadegh
Shafiei St., Qods St., Enghelab St., Tehran, Iran
Tehran Iran (Islamic Republic of) 9171971631 +98 935 563 3390 m-mosadegh@razi.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Confirmation of the occurrence of sepsis in patients with the initial assessment of the patient's clinical symptoms and laboratory parameters Patients over 18 years old Primary diagnosis of sepsis (have at least two of the following four symptoms: hypothermia or hyperthermia, tachycardia, tachypnea, and leukocytosis or leukopenia) by an infectious specialist or a positive MDR culture 18 years no limit Both History of consuming corticosteroids and immunosuppressive drugs Pregnant and lactating mothers A49.9 Bacterial infection, unspecified Treatment - Drugs Placebo Intervention group: Patients in the intervention group, in addition to the standard treatment panel, receive Nutrition Bio-Shield (NBS) powder as follows: the amount of NBS 500 mg capsule is 4.5 g daily in three doses: 1.5 g in the morning, 1.5 g in the afternoon, and 1.5 g The night is for 14 days. Control group: In addition to the standard treatment regimen, patients in the control group also receive placebo capsules that are given in the morning, noon, and night. Measurement of inflammatory factors. Timepoint: Measurement at the beginning of the study (before the start of the intervention) and 14 days after the start of NBS powder consumption. Method of measurement: Gold standard methods (ESR measurement by Westergren method, CRP measurement by Electrochemical Immunoassay method). Measurement of white blood cells. Timepoint: Measurement at the beginning of the study (before the start of the intervention) and 14 days after the start of NBS powder consumption. Method of measurement: Cell Counter. Mortality Rate. Timepoint: After completing the intervention. Method of measurement: Checking the patient's clinical symptoms. Tehran University of Medical Sciences Approved 2023-03-15 Research Ethics Committees of Imam Khomeini Hospital Complex; Tehran University of Medical Sciences Imam Khomeini Hospital Complex, Qarib St., Tehran Tehran Tehran Iran (Islamic Republic of)