The Effect of Adaptogen Elixir on Sleep Improvement

TCI

Status: Completed

Conditions: Sleep Disorder; Anxiety Disorders

Treatments: Dietary Supplement: Placebo drink; Dietary Supplement: Adaptogen Elixir drink

Study type: Interventional

Funder types: Industry

Identifiers

NCT06279312

N202311065

Details and patient eligibility

About

This study aims to examine the effectiveness of Adaptogen Elixir herbal drink in relieving emotions and improving sleep quality. Participants will be randomly assigned to either the placebo group or the Adaptogen Elixir herbal drink group, with 25 participants in each group. On the day of the experiment (week 0), participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions. Subsequently, participants will be given the experimental samples and instructed to consume them continuously for 4 weeks following the instruction. Follow-up assessments will be conducted in the 2nd and 4th weeks, participants are required to collect blood and saliva samples, fill out questionnaires assessing sleep disorders and stress condition, and use a sleep monitoring system to track their sleep and autonomic nervous system conditions.

Enrollment: 52 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adults aged above 18 years old.
• Individuals experiencing insomnia issues (PSQI > 5) or high levels of anxiety (GAD-7 > 9).
• No medication use or regular use of sleeping pills or antidepressants in the past month.
• No ongoing mental illnesses.
• No ongoing physical illnesses.
• No other sleep disorders.
• No circadian rhythm issues.
• No consumption of sleep or stress-related supplements in the past month.

Exclusion criteria

• Pregnant or breastfeeding women.
• Individuals with significant organic diseases such as organ transplants, epilepsy or seizures, liver or kidney diseases, malignant tumors, endocrine disorders, or a history of alcohol or substance use disorders.
• Individuals known to be allergic to any components of the product.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups, including a placebo group

Placebo drink

Placebo Comparator group

Description:

consume 1 drink per day for 4 weeks

Treatment:

Dietary Supplement: Placebo drink

Adaptogen Elixir drink

Experimental group

Description:

consume 1 drink per day for 4 weeks

Treatment:

Dietary Supplement: Adaptogen Elixir drink