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 first degree relatives, Oral or enteral nutrition (nasogastric or orogastric tube). Exclusion Criteria: Pregnancy or breast feeding, Severe and active bleeding, Re-hospitalization or referral ICU patients from other ICUs, History of obstructive liver disease and biliary disorders, Allergy to Turmeric or products containing 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: Mortality in ICU and 60-days mortality. Secondary outcomes: duration of hospitalization and mechanical ventilation, GCS, APACHE, SOFA, mNUTRIC, CBC, BS, Na, K, Ca, P, Mg, ALT, AST, BUN, Cr, CRP, Blood coagulation tests including PT, PTT, INR.

Block randomization was done using the block sizes of 3, 6 and 9 with randomization websites (www.sealedenvelope.com). After randomization, the type of treatment is written in A/B/C codes in separate papers and placed in an opaque envelope or the paper will wrap so that no one can see inside the paper (random concealment). After obtaining informed consent from the participants, one paper will be taken in order and according to the noted code, the patient is place in one of the interventions or placebo groups.

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).