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临床试验/NCT03947554
NCT03947554已完成1 期

Study of the Efficacy of Panax Ginseng Herbal Preparation HRG80 for Prevention and Mitigation of the Symptoms of Stress in Healthy Subjects

EuroPharma, Inc.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年4月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Change in Perceived Stress Scale (PSS) from baseline to the last day of treatment

研究概览

简要总结

This study evaluates the effects of a specific herbal preparation of Panax ginseng in preventing symptoms of stress in healthy individuals.

详细描述

HRG80 is an herbal preparation of Panax ginseng with a higher concentration of bioavailable ginsenosides than typical Korean ginseng. This study will test whether HRG80 is effective at preventing symptoms of stress, such as fatigue, impaired memory, difficulty in concentration, attention deficit, restlessness, and irritation related to daily work situations of healthy individuals in comparison to placebo and a standard Pananx ginseng with a lower concentration of ginsenosides.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individuals experiencing at least one symptom of stress and fatigue during 8 hours of mental work with a computer.
  • Men and women ages 18-65 (all races and ethnicities)
  • Able to understand and participate in an 11-week study

排除标准

  • Taking medicine or dietary supplements which may have potential effects on cognitive function
  • Consuming more than 1 cup of coffee daily (in the morning).

结局指标

主要结局

Change in Perceived Stress Scale (PSS) from baseline to the last day of treatment

时间窗: Two weeks

The Perceived Stress Scale is a psychological instrument for measuring the perception of stress by an individual. Scores from 0-13 indicate low stress, 14-26 is considered moderate stress, and scores from 27-40 indicate high perceived stress. The primary outcome is the change in the baseline PSS score for HRG80 versus standard Panax ginseng and placebo.

次要结局

未报告次要终点

研究者

发起方
EuroPharma, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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