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临床试验/NCT02931747
NCT02931747已完成1 期

Effect of Bacopa Monnieri on Working Memory and Cognitive Processing in Student

Khon Kaen University1 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
75
试验地点
1
主要终点
Attention using the latency of N100 wave

研究概览

简要总结

The purpose of this study is to determine the effect of Bacopa Monnieri on working memory and cognitive processing in student.

详细描述

Learning and working memory are two of the key role for studying and work successful for student particular the high school student who study hard and preparing themselves for the graduate study. The consumption of brain booster product or functional food for improving memory has gained much attention. It has been reported that Bacopa Monnieri could improve learning and working memory in elderly subject by improving the N100 and P300 event related potential. Therefore, Bacopa Monnieri might be the potential product for improving the learning and working memory in student particular high school student.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
15 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Healthy student subject aged between 15-18 years old who studying in the school within Khon Kaen province.
  • •Body mass index is between 18.5-24.9

排除标准

  • •Subjects who are diagnosed with one of the following: cardiovascular diseases, respiratory disease, neuropsychological diseases, head injury, diabetes mellitus, liver disease, cancer, autoimmune disease and hematological disorder are excluded.
  • •Subjects who take any medicine or nutraceuticals or hormone that effect on central nervous system are excluded.
  • •Alcohol addict or smoking addiction (more than 10 pieces/day)
  • •Athlete or subjects who have a regular exercise more than 3 times/week
  • •Subjects who don't follow the instruction during the trial
  • •Subjects who are participating the other project.

研究组 & 干预措施

Placebo

Placebo Comparator

Subjects are received the pill of placebo which has same color, shape and smell like the Bacopa Monnieri once daily for 16 weeks.

干预措施: Placebo (Dietary Supplement)

Bacopa Monnieri 300 mg/day

Active Comparator

Subjects are received the pill of Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks

干预措施: Bacopa Monnieri 300 mg/day (Dietary Supplement)

Bacopa Monnieri 600 mg/day

Active Comparator

Subjects are received the pill of Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks

干预措施: Bacopa Monnieri 600 mg/day (Dietary Supplement)

结局指标

主要结局

Attention using the latency of N100 wave

时间窗: 4 months

The latency of N100 wave was measured and expressed as millisecond.

Attention using the amplitude of N100 wave

时间窗: 4 months

The amplitude of N100 wave was measured and expressed as micro-volt.

Cognitive processing using the amplitude of P300 wave

时间窗: 4 months

The amplitude of P300 wave was measured and expressed as micro-volt.

Cognitive processing using the latency of P300 wave

时间窗: 4 months

The latency of P300 wave was measured and expressed as millisecond.

次要结局

  • Assessment of mood scale using Bond-Lader visual analogue scales(4 months)
  • Gamma-aminobutyric acid (GABA)-transaminase in serum(4 months)
  • Activity of glutathione peroxidase in serum(4 month)
  • Consumption safety of Bacopa Monnieri using hematological values .(4 month)
  • Consumption safety of Bacopa Monnieri using blood chemistry(4 month)
  • Consumption safety of Bacopa Monnieri using blood pressure measurement(4 month)
  • Assessment of psychiatric symptoms using the symptom check list 90 (SCL-90)(4 months)
  • Activity of superoxide dismutase in serum(4 month)
  • Consumption safety of Bacopa Monnieri using electrocardiogram (EKG)(4 month)
  • Accuracy of working memory using computerized battery test(4 months)
  • Activity of catalase in serum(4 month)
  • Speed of working memory using computerized battery test(4 months)
  • Acetylcholinesterase activity in serum(4 months)
  • Monoamine oxidase activity in serum(4 months)
  • Glutamic acid decarboxylase (GAD) activity in serum(4 months)
  • Malondialdehyde level in serum(4 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jintanaporn Wattanathorn

Associated Professor Doctor

Khon Kaen University

研究点 (1)

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