Psychological StressPhase 1/2NCT03947554
Ginseng HRG80 in Stress and Fatigue
A Phase 1/2 study testing HRG80 Panax ginseng and Panax ginseng in people with Psychological Stress, run by EuroPharma, Inc. at 1 site in Armenia.
Trial summary
This study evaluates the effects of a specific herbal preparation of Panax ginseng in preventing symptoms of stress in healthy individuals. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychological Stress
- What is being tested?
- HRG80 Panax ginseng and Panax ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteArmenia
- Study dates
- 1 Apr 2019to 1 Jul 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Taking medicine or dietary supplements which may have potential effects on cognitive function
- Consuming more than 1 cup of coffee daily (in the morning).
Trial locations and contacts
1 site in 1 country.
Armenia1 site
Sports Medicine and Anti-Doping Service Republican Centre
Yerevan
About this study
Official title: 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.
Read the 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.
- Conditions
- Psychological Stress
- Being tested
- HRG80 Panax ginseng, Panax ginseng, Placebo
- Keywords
- Panax ginseng, Red ginseng, Korean ginseng, Adaptogen
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRG80 Panax ginsengDietary supplement
Panax ginseng containing 63.4 mg ginsenosides
Panax ginsengDietary supplement
Panax ginseng containing 19.6 mg ginsenosides
PlaceboDietary supplement
800 mg excipient
| Study group | Role | What they receive |
|---|---|---|
| HRG80 Panax ginseng | Experimental | Panax ginseng standardized to 63.4 mg of total ginsenosides taken orally once daily in the morning after a meal. Receives: Dietary Supplement: HRG80 Panax ginseng |
| Panax ginseng | Active comparator | Panax ginseng standardized to 19.6 mg of total ginsenosides taken orally once daily in the morning after a meal. Receives: Dietary Supplement: Panax ginseng |
| Placebo | Placebo comparator | Placebo capsule containing brown sugar and rice flour, taken orally once daily in the morning after a meal. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Apr 2019
- Primary completion15 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuroPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Botalys SA
- Responsible party
- Sponsor
- Investigators
- Areg Hovhannisyan, PhD, Dr Sci, Principal investigator, Sports Medicine and Anti-Doping Service Republican Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03947554
- Sponsor's protocol ID
- EP-1005
- Status last verified
- May 2019
- First submitted
- 9 May 2019
- Last updated
- 5 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Efficacy of Panax Ginseng Herbal Preparation HRG80 for Prevention and Mitigation of the Symptoms of Stress in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03947554
- Acronym / sponsor ID
- EP-1005
- Conditions
- Psychological Stress
- Keywords
- Panax ginseng, Red ginseng, Korean ginseng, Adaptogen
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- EuroPharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Botalys SA
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 13 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HRG80 Panax ginseng | Experimental | Dietary Supplement: HRG80 Panax ginsengPanax ginseng standardized to 63.4 mg of total ginsenosides taken orally once daily in the morning after a meal. |
| Panax ginseng | Active comparator | Dietary Supplement: Panax ginsengPanax ginseng standardized to 19.6 mg of total ginsenosides taken orally once daily in the morning after a meal. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsule containing brown sugar and rice flour, taken orally once daily in the morning after a meal. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Taking medicine or dietary supplements which may have potential effects on cognitive function
- Consuming more than 1 cup of coffee daily (in the morning).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRG80 Panax ginsengPanax ginseng containing 63.4 mg ginsenosides | Dietary supplement | HRG80 Panax ginseng |
| Panax ginsengPanax ginseng containing 19.6 mg ginsenosides | Dietary supplement | Panax ginseng |
| Placebo800 mg excipient | Dietary supplement | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Areg Hovhannisyan, PhD, Dr Sci principal investigator
Sports Medicine and Anti-Doping Service Republican Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HRG80 Panax ginseng and Panax ginseng in people with Psychological Stress, run by EuroPharma, Inc. at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Perceived Stress Scale (PSS) from baseline to the last day of treatment (time frame: Two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.