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

NCT06505694 | Completed

• 1 other identifier: 20381
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

Sleep Quality; Sleep Tracker; Relaxation; Herbal Tincture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in Sleep Length and Quality

  Baseline, Week 4, and Week 8

Study Arms (2)

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.

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.

Dietary Supplement: Placebo

Interventions

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.

Test Product Arm

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).

Placebo Arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Apothekary: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind (Participant, Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 17, 2024
• Study Start: May 9, 2024
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)