Ginseng HRG80 in Stress and Fatigue

July 2, 2019 updated by: EuroPharma, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Yerevan, Armenia
        • Sports Medicine and Anti-Doping Service Republican Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EuroPharma, Inc.

Collaborators

Botalys SA

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

June 15, 2019

Study Completion (Actual)

July 1, 2019

Study Registration Dates

First Submitted

May 9, 2019

First Submitted That Met QC Criteria

May 9, 2019

First Posted (Actual)

May 13, 2019

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EP-1005

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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