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IRCT20130829014521N21 IRCT 2023-04-23 Mashhad University of Medical Sciences The effect of Curcumin supplementation on mortality rate and clinical status in patients with trauma Investigating the effect of Curcumin supplementation on mortality rate and clinical status in patients with trauma hospitalized in the intensive care unit 2023-03-21 anticipated 327 Complete https://irct.ir/trial/68501 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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). 2 Trauma. Intervention 1: Intervention group 1: Curcumin tablet twice daily (each tablet contain 500 mg Curcumin plus 5mg Piperine made by Sami-Sabinsa Group Limited) for 7 days. Intervention 2: Intervention group 2: Curcumin tablet once a day (contain 500 mg Curcumin plus 5mg Piperine made by Sami-Sabinsa Group Limited) plus placebo tablet (made by Sami-Sabinsa Group Limited) once a day for 7 days. Intervention 3: Control group: Placebo (microcrystalline cellulose) twice daily (similar to Curcumin tablet in shape, size and color) made by Sami-Sabinsa Group Limited for 7 days. 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 This project conducts between different groups of basic and clinical sciences. All of the collaborators must satisfied with this item. We will decide about this part in future.
public Amihossein Sahebkar
School of Pharmacy, University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948954 0098513180110 sahebkara@mums.ac.ir Mashhad University of Medical Sciences scientific Amirhossein Sahebkar
School of Pharmacy, University Campus, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948954 +98 51 3180 1100 sahebkara@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) 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) 12 years no limit Both Pregnancy or breast feeding Severe and active bleeding Re-hospitalization or refer from other hospitals or ICUs History of obstructive biliary disorders Allergy to Turmeric - - Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: Curcumin tablet twice daily (each tablet contain 500 mg Curcumin plus 5mg Piperine made by Sami-Sabinsa Group Limited) for 7 days. Intervention group 2: Curcumin tablet once a day (contain 500 mg Curcumin plus 5mg Piperine made by Sami-Sabinsa Group Limited) plus placebo tablet (made by Sami-Sabinsa Group Limited) once a day for 7 days Control group: Placebo (microcrystalline cellulose) twice daily (similar to Curcumin tablet in shape, size and color) made by Sami-Sabinsa Group Limited for 7 days Mortality during the intervention in the ICU (8-day ICU mortality). Timepoint: During the first 8-day ICU stay. Method of measurement: Observation and record in checklist. 60-days mortality. Timepoint: Mortality during the 60 days after entering to the study. Method of measurement: The information will be obtained by phone call. 30-days mortality. Timepoint: Mortality during the 30 days after entering to the study. Method of measurement: The information will be obtained by phone call. Duration of hospitalization. Timepoint: Duration of hospitalization will be recorded at the end of the study period. Method of measurement: Observation (record in checklist). Duration of mechanical ventilation. Timepoint: Duration of mechanical ventilation will be recorded at the end of the intervention period. Method of measurement: Observation (record in checklist). GCS (Glascow coma scale). Timepoint: Before and after the intervention period (7 days). Method of measurement: Summing the scores of eye opening, verbal response and motor response. APACHE II(Acute Physiology and Chronic Health Evaluation). Timepoint: Before and after the intervention (7 days). Method of measurement: According to scoring system (APACHE is a severity-of-disease classification system that estimates mortality based on a number of laboratory values and patient signs taking both acute and chronic disease into account. This score will be calculated based on the guidelines and recorded in the checklist). SOFA (Sequential Organ Failure Assessment). Timepoint: Before and after the intervention (7 days). Method of measurement: According to scoring system (SOFA score is a scoring system that assesses the performance of several organ systems in the body). Modified nutrition risk in critically ill (mNUTRIC) score. Timepoint: Before and after the intervention (7 days). Method of measurement: According to scoring system (mNUTRIC is used to assess the nutrition risk in critically ill patients. This score estimates the risk according to some variables such as age, the number of comorbidities, hospitalization days, etc. This score will be calculated based on the guidelines and recorded in the checklist). Complete blood count (CBC). Timepoint: Before and after the intervention period (7 days). Method of measurement: Blood test. Blood sugar (BS). Timepoint: Before and after the intervention period (7 days). Method of measurement: Blood test. Concentration of sodium (Na) in the blood. Timepoint: Before and after the intervention period (7 days). Method of measurement: Blood test. Concentration of Potassium (K) in the blood. Timepoint: Before and after the intervention period (7 days). Method of measurement: Blood test. Liver enzymes including aspartate transaminase (AST) and alanine transaminase (ALT). Timepoint: Before and after the intervention period (7 days). Method of measurement: Blood test. Blood urea nitrogen (BUN). Timepoint: Before and after the intervention period (7 days). Method of measurement: Blood test. Creatinine. Timepoint: Before and after the intervention period (7 days). Method of measurement: Blood test. C-Reactive Protein (CRP). Timepoint: Before and after the intervention period (7 days). Method of measurement: Blood test. Length of stay in ICU. Timepoint: Length of stay in ICU will be recorded at the end of the study period. Method of measurement: Observation (record in checklist). Creatine phosphokinase (CPK). Timepoint: Before and after the intervention period (7 days). Method of measurement: Blood test. 120-day mortality. Timepoint: Mortality during the 120 days after entering to the study. Method of measurement: The information will be obtained by phone call. 180-day mortality. Timepoint: Mortality during the 180 days after entering to the study. Method of measurement: The information will be obtained by phone call. Mashhad University of Medical Sciences Approved 2023-03-04 Research Ethics Committees of Mashhad University of Medical Sciences Ghoreshi Building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)