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

Completed

• Conditions: Sleep Disorders Related to Anxiety

• Registration Number: NCT02981238
• Lead Sponsor: PiLeJe

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.

Study Timeline

• Study Start: 2016-09-20
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-05
• Primary Completion: 2017-01-12
• Study Completion: 2017-01-12
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-13
• Last Update Posted: 2018-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
evolution of the Index of Severity of Insomnia (ISI)	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 Outcome Measures

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

Trial Locations

Locations (1)

Pileje Network of general practitioners; 🇫🇷 Paris, France