traumatic brain injury. Unspecified intracranial injury
Conditions
Interventions
Intervention 1: Intervention group: People will receive 200 mg of bromelain 3 times a day for 14 days. Intervention 2: Control group: Subjects will receive a placebo daily for 14 days.
Sponsors
Artesh University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Patients with moderate to severe traumatic brain injury hospitalized in the intensive care unit, 7=GCS=12 Age range from 18 to 65 years Stability of hemodynamic and metabolic status in the first 24 to 48 hours Having nutritional support for the patient through gavage Willingness to cooperate and sign the informed consent form after being fully informed about the objectives and method of conducting the study by the person herself or her legal guardian.
Exclusion criteria
Exclusion criteria: Having an underlying cancer disease, autoimmune diseases, congenital metabolic diseases, acute or chronic liver failure, chronic kidney failure, and acute kidney failure if the patient needs dialysis pregnancy and breastfeeding history of known food allergy Unwillingness to participate in the study suffering from sepsis or any acute or chronic infection allergy to supplements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| C reactive protein. Timepoint: At the beginning and 14 days after the intervention. Method of measurement: Serum measurement by enzyme-linked immunosorbent assay (ELISA) method.;Erythrocyte sedimentation rate. Timepoint: At the beginning and 14 days after the intervention. Method of measurement: Special measuring kit.;Malondialdehyde. Timepoint: At the beginning and 14 days after the intervention. Method of measurement: Special measuring kit.;Total antioxidant capacity. Timepoint: At the beginning and 14 days after the intervention. Method of measurement: Special measuring kit.;28 day and 60 day mortality. Timepoint: ??? 28 ? 60. Method of measurement: Registration of death in the patient's file.;Interleukin-6. Timepoint: At the beginning and 14 days after the intervention. Method of measurement: Serum measurement by enzyme-linked immunosorbent assay (ELISA) method. | — |
Secondary
| Measure | Time frame |
|---|---|
| Glasgow Coma Scale. Timepoint: The beginning of the study, day 7 and 14. Method of measurement: Glasgow coma scale score.;Acute Physiology and Chronic Health Evaluation (APACHE II). Timepoint: The beginning of the study, day 7 and 14. Method of measurement: APACHE score.;Sequential Organ Failure Assessment (SOFA). Timepoint: The beginning of the study, day 7 and 14. Method of measurement: SOFA score.;Nutrition Risk in the Critically Ill (NUTRIC). Timepoint: The beginning of the study, day 7 and 14. Method of measurement: NUTRIC score. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSaid Hadi
Artesh University of Medical Sciences
Outcome results
None listed