Investigating the effect of Curcumin supplementation on mortality rate and clinical status in patients with trauma hospitalized in the intensive care unit

Investigating the effect of Curcumin supplementation on mortality rate and clinical status in patients with trauma hospitalized in the intensive care unit

Triple-blind parallel randomized clinical trial with control group, phase 2, on 327 patients. We will use the website (www.sealedenvelope.com) for randomization.

Traumatic ICU admitted patients in Bahonar hospital in Kerman, with mentioned inclusion criteria, will be enrolled to this study after informed consent. They will be divided into 2 groups of intervention and 1 control group. The duration of intervention will be 7 days and it will be administered by dissolving the powder inside capsule in gavage solution.

Inclusion Criteria: Minimum age of 12 years old, ICU admission due to trauma, Sign informed consent by the patients or his legal guardian, Oral or enteral nutrition (nasogastric or orogastric tube). Exclusion Criteria: Pregnancy or breast feeding, Severe and active bleeding, Re-hospitalization or refer from other hospitals/ICUs , History of obstructive biliary disorders, Allergy to Turmeric.

ّFirst intervention group: Curcumin tablet twice daily (each tablet contain 500 mg Curcumin plus 5mg Piperine) for 7 days made by Sami-Sabinsa Group Limited. Second intervention group: Curcumin tablet once a day (contain 500 mg Curcumin plus 5mg Piperine) plus placebo once a day (for 7 days) made by Sami-Sabinsa Group Limited. Control group: placebo twice daily for 7 days made by Sami-Sabinsa Group Limited.

Primary outcomes: 8day ICU-mortality and 30-day and 60-days mortality. Secondary outcomes: duration of hospitalization, stay at ICU, and mechanical ventilation, GCS, APACHE, SOFA, mNUTRIC, CBC, BS, Na, K, ALT, AST, BUN, Cr, CRP, CPK, 120-and 180-day mortality

Revise outcomes (add new secondary outcomes)

Block randomization was conducted using the block sizes of 3, 6, and 9 with the help of randomization websites (www.sealedenvelope.com). Once A/B/C codes were generated, a list including 327 numbers corresponding to the A/B/C codes will be prepared by a third party and given to the researcher. Someone outside of the research team will pack and label the drugs (from 1 to 327). After obtaining informed consent from eligible participants, one pack of drugs is taken and used accordingly. After completing the data gathering process, each number and its corresponding A/B/C codes will be entered into the software for analysis. Upon completion of the analysis, the A/B/C codes will be decoded.

As mentioned before, after randomization, the patients place in three groups of A/B/C and received the products similar in shape and color (blinding of participants). The physician/nurse who will give the products to participants, received the boxes of the products with randomized codes (so the physician is blind too). The information of the patients and theirs treatment groups will be written with randomized codes (A/B/C) on datasheets (the blinding of the assessor). Data will be entered to the SPSS software with codes (the blinding of the analyzer).