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

Apothekary

Status: Active, not recruiting

Conditions: Anxiety; Stress

Treatments: Dietary Supplement: Alcohol Alternative Herbal Tincture (Test Product); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06505694

20381

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Test Product Arm

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Alcohol Alternative Herbal Tincture (Test Product)

Placebo Arm

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo