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临床试验/NCT02731495
NCT02731495已完成2 期

Effect of Green Tea Epigallocatechin -3-gallate Supplementation on Traumatic Brain Injury Patients' Outcomes

National Nutrition and Food Technology Institute2 个研究点 分布在 2 个国家目标入组 30 人开始时间: 2015年3月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Glasgow Coma Scale (GCS)

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 65 Years(Child, Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Glasgow Coma Scale (GCS)

时间窗: 7 days

Duration of mechanical ventilation

时间窗: 14 days

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

ICU stay

时间窗: 14 days

Serum S100 level

时间窗: 7 days

次要结局

未报告次要终点

研究者

发起方
National Nutrition and Food Technology Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Azita Hekmatdoost

Associate professor

National Nutrition and Food Technology Institute

研究点 (2)

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