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.

Determining the effect of NBS herbal supplement on the treatment of multi-drug resistant nosocomial bloodstream infections in patients referred to the emergency care unit.

A parallel groups, double-blinded, randomized, and phase 3 clinical trial on 94 patients. RAND function of Excel software was used for randomization.

In the present study, patients, researchers, nurses and statisticians do not aware about the patients grouping who receive NBS powder. This clinical trial will be conducted at Imam Khomeini Hospital in Tehran. Patients in the intervention group (n=47), in addition to receiving the routine treatment adopted by the attending physician based on the guidelines, will also receive NBS powder for 14 days. The control group (n=47) also received the same treatment panel along with placebo for 14 days. Before and after the intervention, the demographic and laboratory parameters considered in this study are collected from the patients and recorded in the file. Finally, the results will be analyzed by statistical methods.

In this study, patients over 18 years old, whose bloodstream infections has been confirmed by a specialist with clinical symptoms and laboratory parameters, are included in the study. On the other hand, suffering from chronic and autoimmune diseases as well as the use of immunosuppressive drugs by patients are the main criteria for excluding them from the study.

The intervention group will be prescribed 5.4 grams of NBS powder daily in three doses of 1.5 grams for 14 days along with the main treatment panel. The control group will also receive a placebo in addition to the main treatment panel.

Mortality rate; white blood cells counts; hospitalization period

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.

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.