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Completed

NCT Number: NCT03947554

Ginseng HRG80 in Stress and Fatigue

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

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Key information

Conditions

Psychological Stress Behavior Behavioral Symptoms Stress, Psychological

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sports Medicine and Anti-Doping Service Republican Centre

Yerevan, Armenia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

HRG80 Panax ginseng

Dietary Supplement

Panax ginseng containing 63.4 mg ginsenosides

Panax ginseng

Dietary Supplement

Panax ginseng containing 19.6 mg ginsenosides

Placebo

Dietary Supplement

800 mg excipient

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

EuroPharma, Inc.

Industry

Collaborators

  • Botalys SA

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 13, 2019
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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