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Effects of Melissa Extract on Sleep Characteristics

NCT05950932 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-07-18

No results posted yet for this study

Summary

The plant Melissa officinalis L. is commonly used to treat disorders related to anxiety and sleep quality. It contains several phytochemicals that give it antioxidant, anti-inflammatory, antispasmodic, antimicrobial, and neuroprotective properties. A study on subjects with mild to moderate anxiety and sleep disorders showed that an extract of Melissa officinalis reduced anxiety manifestations by 18%, improved symptoms associated with anxiety by 15%, and reduced insomnia by 42%. However, that study did not have a control group, so a randomized trial with a control group is needed. The objective of the study will be to evaluate the beneficial effects of a phytosome-formulated Melissa officinalis extract on sleep duration and different stages of sleep, which will be monitored using a wrist device. She will be provided with a wrist device that will be used for sleep monitoring. The trial will last for 45 days, in which she will be asked to take the phytosome-formulated Melissa supplement for two 14-day periods (2 tablets, 30 minutes before bedtime). There will be a 7-day break in the intake period between the two periods. At the beginning, middle, and end of the trial, you will be asked to answer some questionnaires.

Conditions

  • Sleep Disorder
  • Anxiety
  • Quality of Life

Interventions

DIETARY_SUPPLEMENT

Melissa phytosome

Melissa phytosome® is composed of dry extract of Berberis aristata root (550mg/cpr), complexed with phospholipids (soy lecithin), Pisum sativa proteins, and proanthocyanidin oligomers from Vitis vinifera. 2 tablets of 200 mg Melissa phytosome will be provided to participants, to be taken 30 minutes before bedtime for 14 days.

OTHER

Placebo

2 tablets with an equivalent form, color, flavor, and coating as the experimental product, to take 30 minutes before bedtime.

Sponsors & Collaborators

  • University of Pavia

    collaborator OTHER

  • University of Urbino "Carlo Bo"

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2024-03-31
Completion
2024-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT05950932 on ClinicalTrials.gov