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IRCT20201220049774N5 IRCT 2022-11-21 Mashhad University of Medical Sciences Evaluation of the patients with severe traumatic brain injury receiving the curcumin-piperine supplement Evaluation of the injury severity and organ dysfunction in patients with severe traumatic brain injury receiving the curcumin-piperine supplement 2022-12-07 anticipated 44 Complete https://irct.ir/trial/66900 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A replacement block using the site https://www.sealedenvelope.com with the explanation that each of the blocks has 4 members and the shape of the blocks can be as follows: [ABAB], [BBAA], [BABA], … Codes A and B are randomly assigned to intervention and control groups. The site mentioned above randomly selects 11 blocks out of all four possible blocks to include all patients in the study, Blinding description: In this study, only the expert of the hospital's drug usage evaluation unit has full knowledge of the type of drug received (placebo or curcumin-piperine supplement) and this person has no role in prescribing, evaluating treatment, and analyzing data. Patients who meet the conditions for entering the study are randomly assigned to one of the groups by the aforementioned expert based on the set codes. Then the pills are placed in the hands of researchers who are unaware of the content of the codes and the type of pills, and they are prescribed. The placebo tablet looks completely similar to the curcumin-piperine tablet and contains the same ingredients except for the active ingredient. Therefore, it is not possible to distinguish pills from each other by patients and clinical caregivers. 3 Severe traumatic brain injury. Intervention 1: Intervention group: 22 patients in the group receiving curcumin-piperine supplement during the first 12 hours after brain trauma will receive curcumin-piperine tablets at a dose of 500/5 mg twice a day for 7 days along with standard treatment. Intervention 2: Control group: 22 patients in the control group will receive a placebo pill twice a day for 7 days along with standard treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is I have not decided yet.
public Hesamoddin Hosseinjani
Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi University Campus, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1586 hosseinjanih@mums.ac.ir Mashhad University of Medical Sciences scientific Hesamoddin Hosseinjani
Department of Clinical Pharmacy, Faculty of Pharmacy, Ferdowsi University Campus, Azadi Square, Mashhad
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1586 hosseinjanih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 70 years Less than 12 hours have passed since the brain trauma. The patient has been diagnosed with severe non-penetrating traumatic brain injury. The patient's GCS at the time of visit should be equal to or less than 8. Sign the informed consent form 18 years 70 years Both The impossibility of using nasogastric tube feeding Patients with severe trauma are candidates for craniotomy surgery Pregnancy or breastfeeding History of allergy to turmeric or curcumin product Concomitant receipt of any drug or supplement with an antioxidant or anti-inflammatory effect or an approved immune system regulator S06.2 Diffuse traumatic brain injury Treatment - Drugs Treatment - Drugs Intervention group: 22 patients in the group receiving curcumin-piperine supplement during the first 12 hours after brain trauma will receive curcumin-piperine tablets at a dose of 500/5 mg twice a day for 7 days along with standard treatment. Control group: 22 patients in the control group will receive a placebo pill twice a day for 7 days along with standard treatment. C-reactive protein (CRP). Timepoint: once at study entry and again after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory tests. Glasgow Coma Scale (GCS). Timepoint: once at study entry and again after receiving the last dose of curcumin-piperine. Method of measurement: Clinical test. Neutrophil-lymphocyte ratio (NLR). Timepoint: once at study entry and again after receiving the last dose of curcumin-piperine. Method of measurement: Laboratory test. Sequential Organ Failure Assessment (SOFA) Score. Timepoint: once at study entry and again after receiving the last dose of curcumin-piperine. Method of measurement: Clinical test. Mashhad University of Medical Sciences Approved 2022-06-11 Research Ethics Committee of Mashhad University of Medical Sciences Research and Technology Vice-Chancellor, Qureshi Building, next to Hoize Cinema, University St. Mashhad Razavi Khorasan Iran (Islamic Republic of)