Brain WavesPhase 4NCT04167449
Effects of Korean Red Ginseng Extract on Electrical Brain Activity in Elderly Subjects
A Phase 4 study testing HRG80 Hydroponic Red Ginseng and Conventional White Ginseng in people with Brain Waves, run by EuroPharma, Inc. at 1 site in Germany.
Trial summary
A prospective, randomized, double blind, placebo-controlled study to determine if a hydroponically-cultivated red ginseng preparation is superior to conventionally grown ginseng and placebo for positively affecting electrical activity of the brain during performance of various cognitive tasks. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Waves
- What is being tested?
- HRG80 Hydroponic Red Ginseng and Conventional White Ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2019to 1 May 2020
- Phase
- Phase 4
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject must be capable of giving informed consent.
- Acceptance of written consent to participate in the study after instruction in written and oral form (informed consent).
Who cannot join
- Subjects with acute or chronic diseases that are relevant to the study and asked for by the study staff are excluded:
- Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination.
- Clinically relevant allergic symptoms.
- Detection of alcohol at the time of initial examination (day SC) or on any study (positive alcohol test) or by case history.
- Consumption of clinically relevant medication during last 14 days before and during the active study period based on the notification of the subject or his case history.
- Consumption of medication with primarily central action (i.e. psychotropic drugs or centrally acting antihypertensive drugs). Known intolerance / hypersensitivity (allergy) to plant derived extracts or any of the ingredients of the investigational product (anamnestic).
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- Consumption of unusual quantities or misuse of coffee (more than 4 cups a day), tea (more than 4 cups a day).
- Smoking in the study center on study days A, B, C and D.
- Participation in another clinical trial within the last 60 days.
- Bad compliance.
- Cancellation of informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Korean Red Ginseng Extract on Electrical Brain Activity in Elderly Subjects. A Prospective, Randomized, Double Blind, Placebo-controlled, 3-armed Cross-over Study
A prospective, randomized, double blind, placebo-controlled study to determine if a hydroponically-cultivated red ginseng preparation is superior to conventionally grown ginseng and placebo for positively affecting electrical activity of the brain during performance of various cognitive tasks.
- Conditions
- Brain Waves
- Being tested
- HRG80 Hydroponic Red Ginseng, Conventional White Ginseng, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRG80 Hydroponic Red GinsengDietary supplement
Powdered root preparation of Panax ginseng standardized to 31.7 mg total ginsenosides
Conventional White GinsengDietary supplement
Powdered root preparation of Panax ginseng standardized to 9.8 mg total ginsenosides
PlaceboDietary supplement
Visually identical placebo capsule containing rice flour
| Study group | Role | What they receive |
|---|---|---|
| Hydroponic Red Ginseng | Active comparator | Not described Receives: Dietary Supplement: HRG80 Hydroponic Red Ginseng |
| Conventional White Ginseng | Active comparator | Not described Receives: Dietary Supplement: Conventional White Ginseng |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo
Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during cognitive performance: d2-test for attention (d2-Test).
Measured: Four weeks
Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo
Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during cognitive performance: memory test (ME-Test).
Measured: Four weeks
Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo
Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during cognitive performance: concentration-performance-test with financial reward (CPT-Test).
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start1 Nov 2019
- Primary completion30 Mar 2020
- Study completion1 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain WavesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuroPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wilfried Dimpfel, PhD, Principal investigator, NeuroCode AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04167449
- Sponsor's protocol ID
- EP-1006
- Status last verified
- Feb 2021
- First submitted
- 15 Nov 2019
- Last updated
- 16 Feb 2021
- 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 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Korean Red Ginseng Extract on Electrical Brain Activity in Elderly Subjects. A Prospective, Randomized, Double Blind, Placebo-controlled, 3-armed Cross-over Study
- ClinicalTrials.gov ID
- NCT04167449
- Acronym / sponsor ID
- EP-1006
- Conditions
- Brain Waves
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EuroPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 1 May 2020 (actual)
- First posted
- 18 Nov 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.
A prospective, randomized, double blind, placebo-controlled study to determine if a hydroponically-cultivated red ginseng preparation is superior to conventionally grown ginseng and placebo for positively affecting electrical activity of the brain during performance of various cognitive tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hydroponic Red Ginseng | Active comparator | Dietary Supplement: HRG80 Hydroponic Red Ginseng |
| Conventional White Ginseng | Active comparator | Dietary Supplement: Conventional White Ginseng |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject must be capable of giving informed consent.
- Acceptance of written consent to participate in the study after instruction in written and oral form (informed consent).
Key exclusion criteria (11 listed)
- Subjects with acute or chronic diseases that are relevant to the study and asked for by the study staff are excluded:
- Acute or chronic disease with an impact on the study, which becomes obvious by case history or clinical examination.
- Clinically relevant allergic symptoms.
- Detection of alcohol at the time of initial examination (day SC) or on any study (positive alcohol test) or by case history.
- Consumption of clinically relevant medication during last 14 days before and during the active study period based on the notification of the subject or his case history.
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 Hydroponic Red GinsengPowdered root preparation of Panax ginseng standardized to 31.7 mg total ginsenosides | Dietary supplement | Hydroponic Red Ginseng |
| Conventional White GinsengPowdered root preparation of Panax ginseng standardized to 9.8 mg total ginsenosides | Dietary supplement | Conventional White Ginseng |
| PlaceboVisually identical placebo capsule containing rice flour | Dietary supplement | Placebo |
Primary outcome
Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo
Time frame: Four weeks
Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during cognitive performance: d2-test for attention (d2-Test).
Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo
Time frame: Four weeks
Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during cognitive performance: memory test (ME-Test).
Change in baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo
Time frame: Four weeks
Responses of electric brain activity as spectral power in 17 different brain regions within 6 specially defined frequency ranges (delta, theta, alpha1, alpha2, beta1 and beta2) during cognitive performance: concentration-performance-test with financial reward (CPT-Test).
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 16 Feb 2021.
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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.
Wilfried Dimpfel, PhD principal investigator
NeuroCode AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HRG80 Hydroponic Red Ginseng and Conventional White Ginseng in people with Brain Waves, run by EuroPharma, Inc. at 1 site in Germany.
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 2 inclusion and 11 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 16 Feb 2021. 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 Germany. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 baseline electrical activity of the brain as measured by Quantitative Electroencephalogram for the hydroponic Korean red ginseng preparation versus conventional ginseng and placebo (time frame: Four weeks). The study lists 3 primary outcomes in all. 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 16 Feb 2021.