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Evaluation of an Herbal Extract on Sleep Parameters

NCT05829902 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2025-01-31

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Aventure AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-09-10
Primary Completion
2024-06-19
Completion
2024-06-24

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05829902 on ClinicalTrials.gov