- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03947554
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
-
-
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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
16 years to 63 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.
|
Panax ginseng containing 63.4 mg ginsenosides
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Active Comparator: Panax ginseng
Panax ginseng standardized to 19.6 mg of total ginsenosides taken orally once daily in the morning after a meal.
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Panax ginseng containing 19.6 mg ginsenosides
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Placebo Comparator: Placebo
Placebo capsule containing brown sugar and rice flour, taken orally once daily in the morning after a meal.
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800 mg excipient
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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
Collaborators
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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