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

NCT02731495 | Completed Phase 2 DMC

• 1 other identifier: 24513540293
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (4)

• Glasgow Coma Scale (GCS)

  7 days

• Duration of mechanical ventilation

  Duration of mechanical ventilation is recorded by a nurse who is blinded to grouping and reported in days.

  14 days

• ICU stay

  14 days

• Serum S100 level

  7 days

Study Arms (2)

EGCG

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo group only received 10 ml of deionized water via gavage for a week.

Dietary Supplement: Placebo (deionized water)

Interventions

EGCG DIETARY_SUPPLEMENT

EGCG (Epigallocatechin -3-gallate)

EGCG

Placebo (deionized water) DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead
• Tehran University of Medical Sciences: collaborator

Study Sites (1)

NNFTRI clinic

Tehran, Tehran Province, 19435, Iran

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 17, 2016
• First Posted: April 7, 2016
• Study Start: March 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: June 7, 2016

Record last verified: 2016-06

Locations

IR (1)