Effect of Epigallocatechin -3-gallate Supplementation in Traumatic Brain Injury Patients
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Traumatic brain injury is the leading cause of death and disability in young adults. Green
      tea Epigallocatechin -3-gallate (EGCG) supplementation might favorably influenced many of the
      processes mention in the secondary insult of TBI including neuroinflammation and
      antioxidative damages.

      The investigators aim to investigate whether treatment with Epigallocatechin -3-gallate
      favorably affect outcomes in traumatic brain injury patients. Therefore, in the current
      randomized double-blind clinical trial, 30 patients (15 patients in each group) with moderate
      to severe head trauma admitted to university hospital intensive care unit will included.
      Patients will either receive a daily oral dose of 400 mg EGCG or placebo for 7 days. The
      major outcomes includes duration of mechanical ventilation, Glasgow Coma Scale (GCS), and
      S100 protein level.
    

Detailed description: 
      Male patients (16-65 year old) who admitted to a university hospital intensive care unit with
      moderate to severe Traumatic Brain Injury (TBI) were enrolled using consecutive sampling.
      Inclusion criteria were GCS of 4-12, enteral nutrition started in 24 hours after admission,
      having mechanical ventilation. The procedure and protocol of the study was approved by the
      Ethic Committee of Tehran University of Medical Sciences. Written informed consent were
      obtained from patient's relative. After recording anamnesis, patients were examined
      physically. Urgent actions were done, simple radiography were taken from skull and CT-scan
      were performed if it is necessary. Patients who had internal bleeding, obvious fractures in
      their limbs, history of metabolic or psychiatric disorder, alcohol or drug dependency,
      underlying diseases, or vegetarian diet would be excluded from the study. Patients' base line
      information including age, sex, vital signs, GCS, clinical symptoms at time of reception,
      diagnosis based on CT-scan, type of treatment (medicinal or surgical) and surgical area of
      body were recorded. patients were then divided into two experimental groups: (1) receiving
      epigallocatechin gallate (EGCG) supplement (case group, n = 15) and (2) receiving placebo
      (control group, n = 15). EGCG supplement was in the form of 400 mg oral capsules with a
      purity of 80% catechin. EGCG powder of each capsule was dissolved in 10 ml deionized water
      and given to patients via gavage (1 capsule per day) for a week. Placebo group only received
      10 ml of deionized water via gavage for a week. During that week, GCS of patients was
      recorded by a neurosurgery resident who was blinded. For seven days, vital signs, glucose,
      hematocrit, haemoglobin, platelet were recorded every day at 9:00 a.m. Duration of the
      connection to mechanical ventilation was also recorded.

      In order to analyze serum S100B protein level, 5 ml serum was taken from patients at 1st day
      and 8th day of the admission and stored at -80⁰C. Human S100B ELISA kit was used to quantify
      the level of S100B protein.

      Statistical analysis

      distribution of all continuous variables was assessed using Kolmogorov-Smirnov test. Normal
      distributed variables were compared by independent samples t-test. Not-normal distributed
      variables were assessed by Wilcoxon-Mann-Whitney U-test. P value less than .05 would be
      considered as statistically significant for all tests. Data were analyzed using SPSS
      Statistics version 21 (SPSS Inc., Chicago, USA).
    

Intervention name(s): EGCG; Placebo (deionized water)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): EGCG (Epigallocatechin -3-gallate)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment