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Effect of Epigallocatechin -3-gallate Supplementation in Traumatic Brain Injury Patients

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ClinicalTrials.gov Identifier: NCT02731495
Recruitment Status : Completed
First Posted : April 7, 2016
Last Update Posted : June 7, 2016
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Brief 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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Dietary Supplement: EGCG Dietary Supplement: Placebo (deionized water) Phase 2 Phase 3

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Green Tea Epigallocatechin -3-gallate Supplementation on Traumatic Brain Injury Patients' Outcomes
Study Start Date : March 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EGCG
Participants were randomly divided based on age, sex and severity of TBI in two groups. Randomization lists was computer-generated by a statistician and participants, project managers and employees at the clinic are completely unaware (blind) about intervention and control groups. At the first visit, baseline data were gathered and patients received 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.
Dietary Supplement: EGCG
EGCG (Epigallocatechin -3-gallate)

Placebo Comparator: Placebo
Placebo group only received 10 ml of deionized water via gavage for a week.
Dietary Supplement: Placebo (deionized water)



Primary Outcome Measures :
  1. Glasgow Coma Scale (GCS) [ Time Frame: 7 days ]
  2. Duration of mechanical ventilation [ Time Frame: 14 days ]
    Duration of mechanical ventilation is recorded by a nurse who is blinded to grouping and reported in days.

  3. ICU stay [ Time Frame: 14 days ]
  4. Serum S100 level [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • GCS of 4-12
  • enteral nutrition started in 24 hours after admission
  • having mechanical ventilation.

Exclusion Criteria:

  • internal bleeding
  • obvious fractures in limbs
  • history of metabolic or psychiatric disorder
  • alcohol or drug dependency
  • underlying diseases
  • vegetarian diet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02731495


Locations
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Iran, Islamic Republic of
NNFTRI clinic
Tehran, Iran, Islamic Republic of, 19435
Sponsors and Collaborators
National Nutrition and Food Technology Institute
Tehran University of Medical Sciences

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Responsible Party: Dr Azita Hekmatdoost, Associate professor, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02731495     History of Changes
Other Study ID Numbers: 24513540293
First Posted: April 7, 2016    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: undecided

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System