Effect of bromelain supplementation in head trauma patients

Phase 3

Recruiting

Conditions: traumatic brain injury.
Unspecified intracranial injury
S06.9

Registration Number: IRCT20181219042047N2

Lead Sponsor: Artesh University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 58

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.