The effect of curcumin in the recovery of severe traumatic brain injury: a double-blind randomized controlled trial

Abstract Background: Traumatic brain injury is one of the most important causes of death in trauma patients among the different types of trauma worldwide. In this study, the effect of Nanocurcumin on the outcome of severe traumatic brain injury, which was performed in humans for the first time, was investigated. Methods: This was a double-blind and paralleled randomized controlled study that was conducted on 128 patients aged 18 to 70 with severe brain trauma. Patients were randomly assigned to two control groups (Standard care treatment + placebo) and intervention group (Standard care treatment + oral Nanocurcumin with the dose of 500mg every 8 hours for three-weeks). Changes in the level of consciousness, cerebral edema, kidney function, liver enzymes, sodium and potassium electrolytes, and brain function of patients in both groups were followed up and compared until 6 months after discharge. Results: The mean and standard deviation of age (Mean + SD) for intervention group (14.44 ± 31.86 years) and control patients (14.86 ± 33.34 years) had no significant difference (p = 0.543). Both groups were similar in terms of gender (p = 0.669). The average level of consciousness of patients in the intervention group increased by about 3 units (p = 0.004) and more than 2 units (p = 0.002) at the time of discharge compared to the control group. By comparing the optimal performance of patients in the first (p = 0.389) and second (p = 0.309) trimesters after discharge, no significant difference was observed between the intervention and control groups. The amount of brain edema caused by severe brain trauma on the seventh day of treatment was lower in the intervention group than in the control group (p = 0.038). The two intervention and control groups did not differ in terms of coagulation factors, liver enzymes, kidney function and sodium on the third and seventh days of hospitalization (P ≥ 0.05). Conclusions: Administration of oral Nanocurcumin supplement in patients with severe brain trauma along with their routine treatment is effective in improving brain edema and their level of consciousness without causing coagulation, liver and kidney complications. These findings are not only statistically significant but also clinically important.