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OpenTrials
Completed

NCT Number: NCT06505694

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.

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Key information

Conditions

Anxiety Anxiety Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stress

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Santa Monica, California, 90404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Placebo

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).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in Sleep Length and Quality

    Time frame: Baseline, Week 4, and Week 8

    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.

Sponsors and collaborators

Lead sponsor

Apothekary

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jul 17, 2024
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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