The effects of saffron supplementation on oxidative stress biomarkers, inflammatory factors, and clinical outcomes in sepsis patients admitted to the intensive care unit (ICU): A double-blind randomized controlled clinical trial

Determining and comparing the effect of supplementation with saffron and placebo on the mean changes in serum levels of inflammatory factors, oxidative stress and clinical outcomes in patients with sepsis hospitalized in the intensive care unit (ICU) before and after the intervention.

Clinical trial study with a control group, with two arm parallel-group, double-blind, randomized, phase 3 on 90 patients. For randomization, the block method (blocks of 4) and the site https://sealedenvelope.com/simple-randomiser/v1) will be used.

This clinical trial will be conducted in patients hospitalized in the ICU of Al-Zahra Hospital (S). Saffron and placebo supplements are given to patients for 7 days in completely similar packages. Patients and researchers will not know the type of intervention.

Sepsis patients aged 18 to 80 years hospitalized

Patients who receive one 100 mg saffron tablet every day for 7 days

Before and after the study, inflammatory factors ESR, CRP, IL-6, TNF-α, IL-18 and CBC, LDH, oxidative stress indicators MDA, catalase, GPx, SOD and TAC and level of consciousness (GCS), scores of the survey form Severity of the disease (APACHE II), organ failure assessment (SOFA) and patient nutrition status form (NUTRIC score) and mortality are evaluated.

In order to randomize, the block method (block of 4) will be used. Also, matching will be done based on GCS (3 to 8 and 9 to 13) and age (18 to 50 and 51 to 80). For randomization using the site (https://sealedenvelope.com/simple-randomiser/v1) after determining the number of blocks and GCS variables and age (as variables based on which matchimg will be performed), all The blocks will be specified along with the type of intervention and the order of allocation of the intervention. The random allocation list of patients will be in the sole possession of an individual outside the plan.

The patients will not know about the intervention because they are in the ICU and they all use the hospital gavage. In order to blind the researchers, saffron and placebo pills are prepared in completely identical packages in terms of shape, smell, color and size. Tableting of the supplement and placebo and HPLC test will be done by experts at Mashhad Faculty of Pharmacy located in Ferdowsi University of Mashhad. The random allocation list of patients will be in the sole possession of an individual outside the plan. In order to hide the process of random assignment (concealment), random codes are written on the paper label without a specific order and framework, which is the identification number of the relevant treatment and only a person outside the plan will be aware of the relevant code. The labels will be stuck on the medicine packages in the order of the randomization list. Medicine packages will be arranged in the order of the randomization list inside the box. When a patient's eligibility is determined, the researcher provides the patient's package treatment plan to the nurses to be administered to the patients along with gavage.

Information about the study will be published after the individuals are not identified and the project is completed.

Access period starts 6 months after the results are published

Only for researchers working in academic and scientific institutions

For further analysis

Dr. Mohammad Bagherniya email: bagherniya@nutr.mui.ac.ir

After reviewing the request and making it fully clear about the purposes of using the data, the data will be provided.