MedTrace Logo

Efficacy and Safety of Valerian Root Extract and Lavender Essential Oil Combination, Over 4 Weeks in Subjects With Sleep Complaints

NCT05194618 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2023-03-14

No results posted yet for this study

Summary

Several epidemiologic studies have clearly shown that sleep complaints are very common in the general population. It involves a predominant complaint of a nonrestorative sleep or dissatisfaction with sleep quality or duration and it is accompanied by difficulties in initiating sleep at bedtime, frequent or prolonged awakenings, or early-morning awakening with an inability to return to sleep.

Lavender oil as well as valerian officinalis are benefiting from a long traditional use in sleep and these products have moderate sedative effects compared to classical hypnotic compounds.

This study is proposed to assess the efficacy and the safety of this combination in subjects with slight to moderate sleep complaints.

Conditions

  • Sleep

Interventions

DIETARY_SUPPLEMENT

Valerian - lavender

1 tablet per day, half hour before bedtime, day 1 to day 28

DIETARY_SUPPLEMENT

Placebo

1 tablet per day, half hour before bedtime, day 1 to day 28

Sponsors & Collaborators

  • University of Bordeaux

    collaborator OTHER

  • University Hospital, Bordeaux

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-02
Primary Completion
2023-03-02
Completion
2023-03-02

Countries

  • France

Study Locations

More Related Trials

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 NCT05194618 on ClinicalTrials.gov