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

Not Applicable

Completed

• Conditions: Stress; Anxiety
• Interventions: Dietary Supplement: Alcohol Alternative Herbal Tincture (Test Product); Dietary Supplement: Placebo

• Registration Number: NCT06505694
• Lead Sponsor: Apothekary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-09
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-07-11
• Study First Posted: 2024-07-17
• Primary Completion: 2024-08-20
• Study Completion: 2024-08-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Test Product Arm	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	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.

Primary Outcome Measures

Name	Time	Method
Improvements in Sleep Quality and Mental Well-Being	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 Outcome Measures

Name	Time	Method
Changes in Sleep Length and Quality	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.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States