Phytotherapy Strategy for Sleep Disorders Related to Anxiety With a Combination of Eschscholtzia and Valerian Extracts

July 13, 2018 updated by: PiLeJe

Descriptive Study of a Phytotherapy Strategy for Sleep Disorders Related to Anxiety With Phytostandard® Eschscholtzia and Valerian, a Dietary Supplement Based on Eschscholtzia and Valerian Extracts

The aim of the study is to evaluate the effect of a one-month supplementation with Phytostandard® Eschscholtzia and valerian on the Insomnia Severity Index (ISI), in insomniac so-called adjustment subjects (occasional or short-term insomnia)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

For this study, 40 patients are going to be included. They will have a supplementation of Phytostandard® Eschscholtzia and valerian, from 2 to 4 tablets per day during 28 days.

on the one hand, during the two visits (inclusion and follow-up), the investigator completes the Hamilton Anxiety Scale (HAM-A). During the inclusion visit, he completes with his patient the epworth scale.

on the other hand, patients complete ISI twice : just after the inclusion visit and just before the follow-up visit. He completes two sleep schedules, the first one during the first week of complement and the second one during the fourth.

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75000
        • Pileje Network of general practitioners

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 64 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients suffering from sleep disorders linked to anxiety

Description

Inclusion Criteria of patients:

  • Currently having sleep disorders related to an anxiety and / or having some in the last 3 months
  • Having an alteration of sleep on the previous month which results in a score strictly greater than 7 according to the index of Severity of Insomnia (ISI)
  • For which the investigator freely advises his patient a complement with Phytostandard® Eschscholtzia and Valerian
  • For which the patient freely agrees to complement itself after advice of his doctor with Phytostandard® Eschscholtzia and Valerian
  • Having been informed of the study and accepting the collection and processing of their data

Exclusion Criteria:

  • Suffering from an anxiety resulting in a HAM-A score (Hamilton Anxiety Rating Scale) greater than or equal to 30
  • With a score on Epworth's sleepiness scale strictly greater than 10 (suggestive of a major hypersomnia)
  • Presenting symptoms of sleep apnea syndrome
  • Presenting symptoms of a restless legs syndrome
  • Presenting a chronic pain syndrome requiring the daily intake of analgesic(s)
  • Under psychotropic treatment (neuroleptic, anxiolytic, antidepressant or hypnotic) or under treatment to alter the waking state (antihistamines, beta-blockers, some cough syrups, etc.)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
evolution of the Index of Severity of Insomnia (ISI)
Time Frame: day 0 and day 28
This outcome is compared with ISI at day 0 : we compared both the global score and each item scores
day 0 and day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evolution of Hamilton Anxiety Scale (HAM-A)
Time Frame: day 0 and day 28
This outcome is compared with HAM-A at day 0
day 0 and day 28
Percentage of Satisfaction
Time Frame: day 28
using a likert scale of satisfaction
day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PiLeJe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2016

Primary Completion (Actual)

January 12, 2017

Study Completion (Actual)

January 12, 2017

Study Registration Dates

First Submitted

November 22, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 5, 2016

Study Record Updates

Last Update Posted (Actual)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PiL-Obs-SLEE-PI-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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