Ginseng HRG80 in Stress and Fatigue

Sponsor

EuroPharma, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT03947554

Collaborator

Botalys SA (Other)

Enrollment

Location

Arms

Actual Duration (Months)

16.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Psychological Stress	Dietary Supplement: HRG80 Panax ginseng Dietary Supplement: Panax ginseng Dietary Supplement: Placebo	Phase 1/Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Jun 15, 2019

Actual Study Completion Date :

Jul 1, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: HRG80 Panax ginseng

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

Panax ginseng containing 63.4 mg ginsenosides

Active Comparator: Panax ginseng

Panax ginseng standardized to 19.6 mg of total ginsenosides taken orally once daily in the morning after a meal.

Dietary Supplement: Panax ginseng

Panax ginseng containing 19.6 mg ginsenosides

Placebo Comparator: Placebo

Placebo capsule containing brown sugar and rice flour, taken orally once daily in the morning after a meal.

Dietary Supplement: Placebo

800 mg excipient

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sports Medicine and Anti-Doping Service Republican Centre	Yerevan		Armenia

Sponsors and Collaborators

EuroPharma, Inc.
Botalys SA

Investigators

Principal Investigator: Areg Hovhannisyan, PhD, Dr Sci, Sports Medicine and Anti-Doping Service Republican Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EuroPharma, Inc.

ClinicalTrials.gov Identifier:

NCT03947554

Other Study ID Numbers:

EP-1005

First Posted:

May 13, 2019

Last Update Posted:

Jul 5, 2019

Last Verified:

May 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by EuroPharma, Inc.

Additional relevant MeSH terms:

Stress, Psychological

Study Results

No Results Posted as of Jul 5, 2019