AnxietyNCT06505694
A Clinical Trial to Assess the Impact of an Alcohol Alternative Herbal Tincture on Signs of Stress Anxiety and Sleep Quality.
A study testing Alcohol Alternative Herbal Tincture (Test Product) in people with Anxiety and Stress, run by Apothekary at 1 site in United States.
Trial summary
This is a virtual randomized placebo-controlled double-blind trial lasting eight weeks. The trial will assess the effects of a test product on improving sleep quality, promoting a sense of calm, and reducing feelings of stress and anxiety, using a sleep tracker and subject-specific questionnaires. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- What is being tested?
- Alcohol Alternative Herbal Tincture (Test Product)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2024to 20 Aug 2024
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21-65 years
- Male or female
- Good general health
- Experience daily feelings of stress and anxiety within the past two weeks
- Experience daily problems with sleeping, reduced energy levels, and fatigue over the past two weeks
- Have used alcohol products to help relax or sleep within the past two weeks
Show all 10Show fewer
- Experience tension in the body within the past two weeks
- Experience problems with relaxing in the evening within the past two weeks
- Willing to abstain from alcohol for the duration of the study
- Willing to maintain stable use of other herbal supplements, over-the-counter medications, or prescriptions during the study
Who cannot join
- Chronic health conditions, including oncological and psychiatric disorders
- Taking SSRIs, sedative, or blood pressure-lowering medications
- Pregnant, breastfeeding, or planning to conceive within the next three months
- Currently enrolled or planning to enroll in another research trial over the next eight weeks
- History of substance abuse
- Known serious allergic reactions requiring an Epi-Pen
Trial locations and contacts
1 site in 1 country.
About this study
This is a virtual randomized placebo-controlled double-blind trial lasting eight weeks. The trial will assess the effects of a test product on improving sleep quality, promoting a sense of calm, and reducing feelings of stress and anxiety, using a sleep tracker and subject-specific questionnaires. The study involves 80 participants who experience sleep issues and feelings associated with stress and anxiety.
- Being tested
- Alcohol Alternative Herbal Tincture (Test Product), Placebo
- Keywords
- Sleep Quality, Sleep Tracker, Relaxation, Herbal Tincture
- Medical subject headings
- Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alcohol Alternative Herbal Tincture (Test Product)Dietary supplement
The test product contains organic vegetable glycerin, distilled water, organic elderberries, organic bilberries, organic beetroot juice powder, organic California poppy (whole plant), organic tart cherry, organic hawthorn berries, organic blue vervain (aerial parts), organic ceylon cinnamon bark, organic black pepper fruit, and L-theanine.
PlaceboDietary supplement
The placebo is designed to match the test product in appearance and taste but does not contain the active herbal ingredients. Participants will take 2 ml of the placebo directly onto the tongue every evening, 1-2 hours before bedtime, for a duration of 8 weeks. The placebo contains organic vegetable glycerin, distilled water, organic beet juice powder, organic tart cherries, organic ceylon cinnamon chips, and natural green food coloring (derived from spirulina and turmeric).
| Study group | Role | What they receive |
|---|---|---|
| Test Product Arm | Experimental | Participants in this arm will receive the test product, which is an alcohol alternative herbal tincture. The intervention includes taking 2 ml of the test product directly onto the tongue every evening, 1-2 hours before bedtime, for a duration of 8 weeks. Receives: Dietary Supplement: Alcohol Alternative Herbal Tincture (Test Product) |
| Placebo Arm | Placebo comparator | Participants in this arm will receive a placebo. The intervention includes taking 2 ml of the placebo directly onto the tongue every evening, 1-2 hours before bedtime, for a duration of 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvements in Sleep Quality and Mental Well-Being
Changes in sleep quality, mental well-being, stress, and feelings of anxiety will be assessed using self-assessment questionnaires. Participants will complete these questionnaires at specified intervals throughout the study to evaluate the effectiveness of the herbal tincture compared to the placebo.
Measured: Baseline, Week 2, Week 4, Week 6, and Week 8
Secondary outcomes (1)
Changes in Sleep Length and Quality
Changes in sleep length and quality will be monitored using a Fitbit sleep tracker. The sleep tracker will collect data on various sleep parameters, including total sleep time and sleep stages, to assess the impact of the herbal tincture compared to the placebo.
Measured: Baseline, Week 4, and Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start9 May 2024
- Primary completion20 Aug 2024
- Study completion20 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Apothekary
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06505694
- Sponsor's protocol ID
- 20381
- Status last verified
- Apr 2025
- First submitted
- 11 Jul 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Impact of an Alcohol Alternative Herbal Tincture on Signs of Stress Anxiety and Sleep Quality.
- ClinicalTrials.gov ID
- NCT06505694
- Acronym / sponsor ID
- 20381
- Keywords
- Sleep Quality, Sleep Tracker, Relaxation, Herbal Tincture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- ApothekaryIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 9 May 2024 (actual)
- Primary completion
- 20 Aug 2024 (actual)
- Study completion
- 20 Aug 2024 (actual)
- First posted
- 17 Jul 2024 (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 is a virtual randomized placebo-controlled double-blind trial lasting eight weeks. The trial will assess the effects of a test product on improving sleep quality, promoting a sense of calm, and reducing feelings of stress and anxiety, using a sleep tracker and subject-specific questionnaires. The study involves 80 participants who experience sleep issues and feelings associated with stress and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Test Product Arm | Experimental | Dietary Supplement: Alcohol Alternative Herbal Tincture (Test Product)Participants in this arm will receive the test product, which is an alcohol alternative herbal tincture. The intervention includes taking 2 ml of the test product directly onto the tongue every evening, 1-2 hours before bedtime, for a duration of 8 weeks. |
| Placebo Arm | Placebo comparator | Dietary Supplement: PlaceboParticipants in this arm will receive a placebo. The intervention includes taking 2 ml of the placebo directly onto the tongue every evening, 1-2 hours before bedtime, for a duration of 8 weeks. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 21-65 years
- Male or female
- Good general health
- Experience daily feelings of stress and anxiety within the past two weeks
- Experience daily problems with sleeping, reduced energy levels, and fatigue over the past two weeks
Key exclusion criteria (6 listed)
- Chronic health conditions, including oncological and psychiatric disorders
- Taking SSRIs, sedative, or blood pressure-lowering medications
- Pregnant, breastfeeding, or planning to conceive within the next three months
- Currently enrolled or planning to enroll in another research trial over the next eight weeks
- History of substance abuse
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 |
|---|---|---|
| Alcohol Alternative Herbal Tincture (Test Product)The test product contains organic vegetable glycerin, distilled water, organic elderberries, organic bilberries, organic beetroot juice powder, organic California poppy (whole plant), organic tart cherry, organic hawthorn berries, organic blue vervain (aerial parts), organic ceylon cinnamon bark, organic black pepper fruit, and L-theanine. | Dietary supplement | Test Product Arm |
| PlaceboThe placebo is designed to match the test product in appearance and taste but does not contain the active herbal ingredients. Participants will take 2 ml of the placebo directly onto the tongue every evening, 1-2 hours before bedtime, for a duration of 8 weeks. The placebo contains organic vegetable glycerin, distilled water, organic beet juice powder, organic tart cherries, organic ceylon cinnamon chips, and natural green food coloring (derived from spirulina and turmeric). | Dietary supplement | Placebo Arm |
Primary outcome
Improvements in Sleep Quality and Mental Well-Being
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Changes in sleep quality, mental well-being, stress, and feelings of anxiety will be assessed using self-assessment questionnaires. Participants will complete these questionnaires at specified intervals throughout the study to evaluate the effectiveness of the herbal tincture compared to the placebo.
1 secondary outcome
Changes in Sleep Length and Quality
Time frame: Baseline, Week 4, and Week 8
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 24 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alcohol Alternative Herbal Tincture (Test Product) in people with Anxiety and Stress, run by Apothekary 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 10 inclusion and 6 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 24 Apr 2025. 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. 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.
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?
Improvements in Sleep Quality and Mental Well-Being (time frame: Baseline, Week 2, Week 4, Week 6, and Week 8). 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 24 Apr 2025.