Evaluation the Effects of French Maritime Pine Bark Extract on the Clinical Status in Traumatic Brain Injury Patients
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 1/Phase 2

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 in TBI patient. One of the ingredients that can be used in
      immunonutrition formulas to reduce inflammation and oxidative stress is French maritime pine
      bark extract.

      Objective: The main objective of present study is surveying the effect of French maritime
      pine bark extract on the clinical, nutritional and inflammatory status of TBI patients as the
      first human study in the world.

      Method: this is double-blind, randomized controlled trial. Block randomization are used.
      Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) 150
      mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status
      (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (Malondialdehyde, total
      antioxidant capacity), at the base line, at the 5th day and at the end of the study (10th
      day) are measured. APACHE ІІ (acute physiologic and chronic health evaluation II) for
      assessment of clinical status of patients and Nutric questionnaires for assessment of
      nutritional status filled out at the base line, 5th day and the end of study. SOFA
      (sequential organ failure assessment) questionnaire for assessment of organ failure filled
      out every other day. The mortality rate will be asked by phone within 28 days of the start of
      the intervention. Weight, body mass index and body composition at baseline, 5th day and 10th
      day of intervention are measured. All analyses will be conducted by initially assigned study
      arm in an intention-to-treat analysis. The data will be expressed as mean ± SD.
    

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
      of unique patient identifiers is generated by the study statistician using a
      computer-generated random block size. The classification is based on age (18 to 40 and 40 to
      65 years old), gender (male / female) and APACHEII score (0 to 35 and 35 to 71) using
      quadruple blocks.
    

Intervention name(s): Dietary Supplement (OLIGOPIN); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and intervention group (n=30) will receive Oligopin supplement. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.; investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and control group (n=30) will receive oral capsules containing 130 mg Microcrystalline Cellulose. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment