Ginseng HRG80 in Stress and Fatigue

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

Detailed Description
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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.

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

Conditions
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Psychological Stress

Intervention / Treatment
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* Dietary Supplement: HRG80 Panax ginseng
* Dietary Supplement: Panax ginseng
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HRG80 Panax ginseng<br>Panax ginseng standardized to 63.4 mg of total ginsenosides taken orally once daily in the morning after a meal. | Dietary Supplement: HRG80 Panax ginseng<br>* Panax ginseng containing 63.4 mg ginsenosides<br>|
| Active Comparator: Panax ginseng<br>Panax ginseng standardized to 19.6 mg of total ginsenosides taken orally once daily in the morning after a meal. | Dietary Supplement: Panax ginseng<br>* Panax ginseng containing 19.6 mg ginsenosides<br>|
| Placebo Comparator: Placebo<br>Placebo capsule containing brown sugar and rice flour, taken orally once daily in the morning after a meal. | Dietary Supplement: Placebo<br>* 800 mg excipient<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Perceived Stress Scale (PSS) from baseline to the last day of treatment | 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. | Two weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Panax ginseng, Red ginseng, Korean ginseng, Adaptogen