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

NCT02731495 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-06-07

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

EGCG

EGCG (Epigallocatechin -3-gallate)

DIETARY_SUPPLEMENT

Placebo (deionized water)

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    collaborator OTHER

  • National Nutrition and Food Technology Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2015-11-30
Completion
2016-01-31

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02731495 on ClinicalTrials.gov