Status:
COMPLETED
Evaluation the Effects of French Maritime Pine Bark Extract on the Clinical Status in Traumatic Brain Injury Patients
Lead Sponsor:
Mashhad University of Medical Sciences
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Introduction: Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate i...
Detailed Description
Randomization: investigators randomly assign eligible patients on enrolment (1:1) to either the control group or the intervention group. Randomization is stratified by site and a randomization list o...
Eligibility Criteria
Inclusion
- Admission in ICU due to TBI2
- 18 year ≤ age ≤ 65 year
- GCS score ˃ 8
- Stable hemodynamic and metabolic status in the first 24 to 48 hours
- Having enteral nutritional support
- Fill out the informed consent form by the patient or first-degree relatives of the patient
Exclusion
- Pregnancy and lactation
- Morbid obesity: BMI ≥ 40
- Failure to start enteral nutrition in the first 24-48 hours
- Suffering from autoimmune disorders and HIV/Aids
- Suffering or having History of cancer and any liver failure
- Receiving positive inotropic medications including Dopamine, Dobutamine and Epinephrine
- Severe and active bleeding
- Suffering from Sepsis
- Having history of known food allergies
Key Trial Info
Start Date :
April 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2020
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT03777683
Start Date
April 14 2019
End Date
February 20 2020
Last Update
May 21 2020
Active Locations (1)
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1
Mahsa Malekahmadi
Tehran, Iran