NCT05829902

Evaluation of an Herbal Extract on Sleep Parameters

Evaluation of an Herbal Extract on Sleep Parameters in Healthy, Middle-aged Women

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Aventure AB · Industry
• Sex: Female
• Age: 35 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The overall purpose of this interventional study is to investigate how a specific herbal extract influences the quality of sleep in middle-aged women with mild to moderate insomnia. During the study, the participants are asked to take the test drink every night for two weeks. Both objective (Oura ring) and subjective (analog sleep diaries, questionnaires) measures are included to evaluate sleep parameters as well as perceived alertness and impact on daily functions. The primary outcome is sleep onset latency (SOL), which is the time it takes for a person to fall asleep. Secondary outcomes which will be evaluated include time spent in different sleep stages, number of times waking up during the night, and various qualitative ratings of energy levels and mood during the day. Researchers will compare the group with active product and placebo product to see if the consumption of the herbal extract will lead to improvements in the factors mentioned above.

Conditions

• Sleep Onset Latency

Interventions

Type	Name	Description
OTHER	Herbal extract drink	30 ml drink containing 600 mg of lemon balm extract, tea leaves, brown sugar and flavoring agent, two weeks daily
OTHER	Placebo	30 ml placebo drink containing maltodextrin, tea leaves, brown sugar and flavoring agent, two weeks daily

Timeline

• Start date: 2023-09-10
• Primary completion: 2024-06-19
• Completion: 2024-06-24
• First posted: 2023-04-26
• Last updated: 2025-01-31

Locations

1 site across 1 country: Sweden