Evaluation of an Herbal Extract on Sleep Parameters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-10

Study Completion Date

2024-06-24

Brief Summary

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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.

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Detailed Description

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Conditions

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Sleep Onset Latency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study is a randomized, placebo-controlled, parallel intervention with two arms. The study is divided into three phases: the run-in period (14 days), the intervention period (14 days) and the follow-up period (14 days). Eligible participants will be randomized in a 1:1 ratio to receive either lemon balm extract or a placebo. Randomization will be stratified by ISI-value and age at baseline. Treatment assignments will be pre-planned according to a computer-generated randomization scheme prepared by a vendor.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

A copy of the randomization list will be provided to those packing the product kits. The randomization list is a document that consists of randomization numbers, which uniquely assign each study patient to one of the treatments. The sponsor and all staff directly involved in the trial will thus be blinded to the product allocated to the participants. The randomization number will be documented.

Study Groups

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Active product

The active product is a drink consisting of 600 mg of lemon balm extract, tea leaves, brown sugar and powdered flavoring agent that is mixed with lukewarm water. The volume per serving is 30 ml. The drink will be taken every night before sleep for a period of two weeks.

Group Type EXPERIMENTAL

Herbal extract drink

Intervention Type OTHER

30 ml drink containing 600 mg of lemon balm extract, tea leaves, brown sugar and flavoring agent, two weeks daily

Placebo

The placebo drink is maltodextrin mixed with water, and the same tea leaves, brown sugar and powdered flavoring agent as the test drink. The volume per serving is 30 ml. The drink will be taken every night before sleep for a period of two weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

30 ml placebo drink containing maltodextrin, tea leaves, brown sugar and flavoring agent, two weeks daily

Interventions

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Herbal extract drink

30 ml drink containing 600 mg of lemon balm extract, tea leaves, brown sugar and flavoring agent, two weeks daily

Intervention Type OTHER

Placebo

30 ml placebo drink containing maltodextrin, tea leaves, brown sugar and flavoring agent, two weeks daily

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female
* Age 35-60
* BMI 18-30 kg/m2
* Mild to moderate insomnia according to the ISI (Insomnia Severity Index) questionnaire (ISI-value 10-21)
* Matching results from the Oura ring and sleep diaries during the run-in period

Exclusion Criteria

* Metabolic disease (diabetes, cardiovascular disorders, hypo- or hyperthyroidism, etc)
* Severe psychiatric disorders
* Pregnancy, breastfeeding
* Restless legs or leg cramps that influence sleep and everyday life
* Conditions that prevent sleep through the symptoms that they produce (pain, nightly coughs, etc)
* Breathing problems (asthma, severe snoring, sleep apnea, etc)
* Medication that can influence sleep and/or wakefulness
* Consumption of herbal sedatives during the last month
* Having someone in the household that needs to be tended to during the night and pose a major risk to disturb the research participant's sleep to a large extent.
* Irregular work hours, including shift work at night
* Regularly sleeping more than 1 night per week away from home
* Tobacco or drug use
* Other factors that are deemed to influence participation negatively

Minimum Eligible Age

35 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes