Ginseng HRG80 in Stress and Fatigue

Psychological Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03947554
• Other study ID #: EP-1005
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 1, 2019
• Est. completion date: July 1, 2019

Study information

• Verified date: May 2019
• Source: EuroPharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 1, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Psychological Stress
• Stress, Psychological

Intervention

Dietary Supplement:
• HRG80 Panax ginseng
Panax ginseng containing 63.4 mg ginsenosides
• Panax ginseng
Panax ginseng containing 19.6 mg ginsenosides
• Placebo
800 mg excipient

Locations

Country	Name	City	State
Armenia	Sports Medicine and Anti-Doping Service Republican Centre	Yerevan

Sponsors (2)

Lead Sponsor	Collaborator
EuroPharma, Inc.	Botalys SA

Country where clinical trial is conducted

Armenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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