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

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 Overview

• Status: Completed
• Conditions: Stress; Anxiety
• Intervention / Treatment: Dietary supplement: Alcohol Alternative Herbal Tincture (Test Product); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: 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.
Placebo Comparator: 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.	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 2, Week 4, Week 6, and Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 4, and Week 8

Collaborators and Investigators

• Sponsor: Apothekary
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Actual): August 20, 2024
• Study Completion (Actual): August 20, 2024

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: July 11, 2024
• First Posted (Actual): July 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2025
• Last Update Submitted That Met QC Criteria: April 22, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Relaxation; Sleep Quality; Sleep Tracker; Herbal Tincture
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 20381

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No