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

NCT ID: NCT02981238

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 36 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-20
• Study Completion Date: 2017-01-12

Brief Summary

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)

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.

Conditions

Sleep Disorders Related to Anxiety

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Phytostandard® Eschscholtzia / Valerian

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PiLeJe

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Pileje Network of general practitioners

Paris, , France

Countries

France

Other Identifiers

PiL-Obs-SLEE-PI-015

Identifier Type: -

Identifier Source: org_study_id