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Ginseng HRG80 in Stress and Fatigue

Primary Purpose

Psychological Stress

Status
Completed
Phase
Phase 1
Locations
Armenia
Study Type
Interventional
Intervention
HRG80 Panax ginseng
Panax ginseng
Placebo
Sponsored by
EuroPharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Psychological Stress focused on measuring Panax ginseng, Red ginseng, Korean ginseng, Adaptogen

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Sports Medicine and Anti-Doping Service Republican Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

HRG80 Panax ginseng

Panax ginseng

Placebo

Arm Description

Panax ginseng standardized to 63.4 mg of total ginsenosides taken orally once daily in the morning after a meal.

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 9, 2019
Last Updated
July 2, 2019
Sponsor
EuroPharma, Inc.
Collaborators
Botalys SA
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1. Study Identification

Unique Protocol Identification Number
NCT03947554
Brief Title
Ginseng HRG80 in Stress and Fatigue
Official Title
Study of the Efficacy of Panax Ginseng Herbal Preparation HRG80 for Prevention and Mitigation of the Symptoms of Stress in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 15, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EuroPharma, Inc.
Collaborators
Botalys SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress
Keywords
Panax ginseng, Red ginseng, Korean ginseng, Adaptogen

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HRG80 Panax ginseng
Arm Type
Experimental
Arm Description
Panax ginseng standardized to 63.4 mg of total ginsenosides taken orally once daily in the morning after a meal.
Arm Title
Panax ginseng
Arm Type
Active Comparator
Arm Description
Panax ginseng standardized to 19.6 mg of total ginsenosides taken orally once daily in the morning after a meal.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo capsule containing brown sugar and rice flour, taken orally once daily in the morning after a meal.
Intervention Type
Dietary Supplement
Intervention Name(s)
HRG80 Panax ginseng
Intervention Description
Panax ginseng containing 63.4 mg ginsenosides
Intervention Type
Dietary Supplement
Intervention Name(s)
Panax ginseng
Intervention Description
Panax ginseng containing 19.6 mg ginsenosides
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
800 mg excipient
Primary Outcome Measure Information:
Title
Change in Perceived Stress Scale (PSS) from baseline to the last day of treatment
Description
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.
Time Frame
Two weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Areg Hovhannisyan, PhD, Dr Sci
Organizational Affiliation
Sports Medicine and Anti-Doping Service Republican Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sports Medicine and Anti-Doping Service Republican Centre
City
Yerevan
Country
Armenia

12. IPD Sharing Statement

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Ginseng HRG80 in Stress and Fatigue

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