Ginseng HRG80 in Stress and Fatigue

Phase 1

Completed

• Conditions: Psychological Stress
• Interventions: Dietary Supplement: HRG80 Panax ginseng; Dietary Supplement: Panax ginseng; Dietary Supplement: Placebo

• Registration Number: NCT03947554
• Lead Sponsor: EuroPharma, Inc.

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2019-04-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-09
• Study First Posted: 2019-05-13
• Primary Completion: 2019-06-15
• Study Completion: 2019-07-01
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
HRG80 Panax ginseng	HRG80 Panax ginseng	Panax ginseng standardized to 63.4 mg of total ginsenosides taken orally once daily in the morning after a meal.
Panax ginseng	Panax ginseng	Panax ginseng standardized to 19.6 mg of total ginsenosides taken orally once daily in the morning after a meal.
Placebo	Placebo	Placebo capsule containing brown sugar and rice flour, taken orally once daily in the morning after a meal.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Sports Medicine and Anti-Doping Service Republican Centre; 🇦🇲 Yerevan, Armenia