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Completed

NCT Number: NCT02981238

Phytotherapy Strategy for Sleep Disorders Related to Anxiety With a Combination of 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)

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Key information

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Pileje Network of general practitioners

Paris, 75000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Phytostandard® Eschscholtzia / Valerian

Dietary Supplement

Primary outcomes

  1. 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

Secondary outcomes

  1. Evolution of Hamilton Anxiety Scale (HAM-A)

    Time frame: day 0 and day 28

    This outcome is compared with HAM-A at day 0

  2. Percentage of Satisfaction

    Time frame: day 28

    using a likert scale of satisfaction

Sponsors and collaborators

Lead sponsor

PiLeJe

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 5, 2016
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.