A Clinical Trial to Assess the Impact of an Alcohol Alternative Herbal Tincture on Signs of Stress Anxiety and Sleep Quality.

NCT ID: NCT06505694

Last Updated: 2025-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-09
• Study Completion Date: 2024-08-20

Brief 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. The study involves 80 participants who experience sleep issues and feelings associated with stress and anxiety.

Conditions

Anxiety; Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Test Product Arm

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.

Group Type: EXPERIMENTAL

Alcohol Alternative Herbal Tincture (Test Product)

Intervention Type: 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.

Placebo Arm

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_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).

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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).

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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
• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Apothekary

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20381

Identifier Type: -

Identifier Source: org_study_id