Evaluation of the effect of curcumin-piperine supplement on damage indicators in septic patients admitted to the intensive care unit

The effect of curcumin-piperine supplementation on CRP reduction in patients with sepsis admitted to the intensive care unit

It is a double-blind clinical trial performed on 66 patients with sepsis admitted to the intensive care unit. The permutation block method will be used for randomization and division of patients.

Intensive Care Unit of Imam Reza (AS) hospital in Mashhad

Inclusion criteria: age between 18 and 80 years, sepsis, signing of the informed consent form Exclusion criteria: pregnancy and lactation, history of allergy to turmeric or curcumin product, age less than 18 years, HIV patients, history of organ transplantation, rheumatic disease or active autoimmunity, patients treated with immunosuppressive drugs, patients treated With corticosteroids, radiotherapy, solid tumors or malignancies, white blood cell count less than 1000 μl, concomitant administration of any drug or supplement with antioxidant or immune regulatory effect, patients without oral/nasal gastrointestinal tract

33 patients in the intervention group will receive a curcumin-piperine supplement at a dose of 500/5mg twice daily with an antibiotic regimen. 33 patients in the control group will receive a placebo twice a day with an antibiotic regimen.

CRP; serum lactate; SOFA score

Permuted blocks method using the site https://www.sealedenvelope.com with the explanation that each block has 6 components. The form of the blocks can be as follows for example: [ABAABAB], [BBABAA], [BABABA], ..... Codes A and B are randomly assigned to intervention and control groups. From all possible six blocks, the site randomly selects 11 blocks to include all the patients in the study.

In this study, the DUE unit expert only has complete information about the type of drug received (placebo or curcumin-piperine supplement). This person plays no role in the administration, treatment evaluation, and data analysis. According to the codes, the patients who fulfill the inclusion criteria are randomly assign to one of the groups by the DUE unit expert. The pills are then given to the researchers who are unaware of the content of the codes and the tablets type, and then prescribed. The placebo pill is very similar in appearance to the curcumin-piperine pill and contains the same ingredients except the active ingredient. Therefore, it is not possible for patients and clinical caregivers to distinguish pills from each other.