CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99 enrolled
Drug / intervention
Lemon balm +1 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05422599
NCT05422599N/ACompleted

A Randomised Double-blind Placebo-controlled Trial on Encapsulated Lemon Balm Efficacy and Tolerance on Sleep Quality Changes, and Mood and Wellbeing Effects Using Objective and Subjective Measures

University of Reading·interventional·Posted Jun 16, 2022·Updated Oct 13, 2023

In Brief

A clinical study evaluating Lemon balm and Placebo for Sleep Disturbance and Mood Disturbance. Completed, enrolled 99 participants across 1 site.

Detailed Summary

This study aims to investigate the effect of a 4-week dietary intervention of 300mg encapsulated aqueous lemon balm extract on measures of sleep quality, mood and well-being, alongside relevant biomarkers of circadian rhythms in healthy adults aged 18-40 years with mild sleep problems (PSQI entry of 5 and above). Three visits to the university alongside completing some home tests involving self-test stool, saliva and mood tests and wearing an wrist-secured actiwatch over 4-weeks whilst recording a daily sleep diary will be monitored to estimate sleep changes. Mood ratings, stool and saliva biomarkers will serve as a proxy to sleep improvement.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
CollaboratorsNaturex

Timeline

N/ACompletedFinished
2023202420252026
First PostedJun 16, 2022
Enrollment StartMay 5, 2022
Primary CompletionMay 23, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.0 years ago

Interventions

Lemon balmdietary

300mg Lemon balm and Maltoxdextrin capsules Other Name: Melissa Officinalis L.

Placebodietary

300mg Maltodextrin capsules