Concentration Ability ImpairedNCT05528094
An Exploratory Investigation of a Supplement to Support Student Learning
A study testing GeniusDrops in people with Concentration Ability Impaired and Mental Fatigue, run by JoySpring at 1 site in United States.
Trial summary
In this trial, the herbal supplement (GeniusDrops) will be tested to see the effects it has on the dependent variables of interest. Participants will take the supplement twice a day for a month and respond to surveys at study baseline, midpoint, and the conclusion of the study. Read more about this study
- Who is it for?
- Ages 5 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Concentration Ability Impaired, Mental Fatigue
- What is being tested?
- GeniusDrops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2022to 15 Dec 2022
- Phase
- Interventional
- 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 5 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Provision of signed and dated informed consent form and a parental assent form
- Must be experiencing issues with focus, mood, and memory
- Must be looking to improve classroom performance
- Gets easily distracted
Who cannot join
- Diagnosis of ADD or ADHD
- Currently taking a prescription medication meant to treat ADD or ADHD
- Diagnosed with additional conditions that would not allow them to adhere to the protocol.
- Willing to take a supplement targeting improving mood, concentration, and focus
Trial locations and contacts
1 site in 1 country.
About this study
In this trial, the herbal supplement (GeniusDrops) will be tested to see the effects it has on the dependent variables of interest. Participants will take the supplement twice a day for a month and respond to surveys at study baseline, midpoint, and the conclusion of the study. The findings of this study will be used for marketing materials and to inform future trials using the supplement.
- Conditions
- Concentration Ability Impaired, Mental Fatigue
- Being tested
- GeniusDrops
- Medical subject headings
- Mental Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GeniusDropsDietary supplement
The active ingredients listed below are safe and the study sponsor has noted there are no known side effects of the supplement. The main ingredients are:
Hibiscus flower- Has been shown to boost oxygenation to the brain and vital organs. Has also demonstrated efficacy for boosting the immune system.
Gingko leaf- Has been shown to stimulate memory by increasing mental sharpness and clarity.
Rhodiola- Helps regulate energy and stress level. Gotu kola- Has been shown to have impacts on reducing anxiety. Licorice Root- Helps boost the key brain neurotransmitter called Brain Derived Neurotrophic factor which can help with cognitive development Peppermint Leaf- Reduces fatigue while helping improve cognitive abilities. Has also been shown to promote immune system function.
| Study group | Role | What they receive |
|---|---|---|
| GeniusDrops | Experimental | Once participants have signed the consent and assent, they will take the baseline survey to gather information about their ability to focus and concentration.
Once in the study, participants will be asked to take two dropperfuls of the test product (Genius Drops) twice daily. The participants can take the dropperful directly or add it to drinks/snacks. Participants will need to be in school during the entirety of the study.
Participants will take a subsequent survey after two weeks in the trial and then another survey at the end of the trial. Receives: Dietary Supplement: GeniusDrops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination of self-reported focus
Participants will respond to a survey to assess perceived changes in focus.
Measured: 4 weeks
Examination of Self-reported concentration
Participants will respond to a survey to assess perceived changes in concentration
Measured: 4 weeks
Examination of Self-reported mood states
Participants will respond to a survey to assess perceived changes in moods.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2022
- Study start14 Apr 2022
- Primary completion15 Dec 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concentration Ability ImpairedStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- JoySpring
- Sponsor type
- University, hospital or other
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
- Investigators
- Christopher Hill, Principal investigator, Citruslabs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05528094
- Sponsor's protocol ID
- 20246
- Status last verified
- Mar 2024
- First submitted
- 1 Sep 2022
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Investigation of a Supplement to Support Student Learning
- ClinicalTrials.gov ID
- NCT05528094
- Acronym / sponsor ID
- 20246
- Conditions
- Concentration Ability Impaired, Mental Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- JoySpringUniversity, hospital or other
- Collaborators
- Citruslabs
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 15 Dec 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 6 Sep 2022 (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.
In this trial, the herbal supplement (GeniusDrops) will be tested to see the effects it has on the dependent variables of interest. Participants will take the supplement twice a day for a month and respond to surveys at study baseline, midpoint, and the conclusion of the study. The findings of this study will be used for marketing materials and to inform future trials using the supplement.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GeniusDrops | Experimental | Dietary Supplement: GeniusDropsOnce participants have signed the consent and assent, they will take the baseline survey to gather information about their ability to focus and concentration. Once in the study, participants will be asked to take two dropperfuls of the test product (Genius Drops) twice daily. The participants can take the dropperful directly or add it to drinks/snacks. Participants will need to be in school during the entirety of the study. Participants will take a subsequent survey after two weeks in the trial and then another survey at the end of the trial. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Provision of signed and dated informed consent form and a parental assent form
- Must be experiencing issues with focus, mood, and memory
- Must be looking to improve classroom performance
- Gets easily distracted
Key exclusion criteria (4 listed)
- Diagnosis of ADD or ADHD
- Currently taking a prescription medication meant to treat ADD or ADHD
- Diagnosed with additional conditions that would not allow them to adhere to the protocol.
- Willing to take a supplement targeting improving mood, concentration, and focus
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 |
|---|---|---|
| GeniusDropsThe active ingredients listed below are safe and the study sponsor has noted there are no known side effects of the supplement. The main ingredients are: Hibiscus flower- Has been shown to boost oxygenation to the brain and vital organs. Has also demonstrated efficacy for boosting the immune system. Gingko leaf- Has been shown to stimulate memory by increasing mental sharpness and clarity. Rhodiola- Helps regulate energy and stress level. Gotu kola- Has been shown to have impacts on reducing anxiety. Licorice Root- Helps boost the key brain neurotransmitter called Brain Derived Neurotrophic factor which can help with cognitive development Peppermint Leaf- Reduces fatigue while helping improve cognitive abilities. Has also been shown to promote immune system function. | Dietary supplement | GeniusDrops |
Primary outcome
Examination of self-reported focus
Time frame: 4 weeks
Participants will respond to a survey to assess perceived changes in focus.
Examination of Self-reported concentration
Time frame: 4 weeks
Participants will respond to a survey to assess perceived changes in concentration
Examination of Self-reported mood states
Time frame: 4 weeks
Participants will respond to a survey to assess perceived changes in moods.
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 6 Mar 2024.
- Individual participant dataSharing planned: Undecided
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.
Christopher Hill principal investigator
Citruslabs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GeniusDrops in people with Concentration Ability Impaired and Mental Fatigue, run by JoySpring at 1 site in United States.
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 4 inclusion and 4 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 6 Mar 2024. 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 United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Examination of self-reported focus (time frame: 4 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 6 Mar 2024.