Pileje Network of general practitioners
Paris, 75000, France
NCT Number: NCT02981238
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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Notify Me18 year–68 year
All sexes
Observational
Paris, 75000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
of patients:
Exclusion criteria
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
Time frame: day 0 and day 28
This outcome is compared with HAM-A at day 0
Time frame: day 28
using a likert scale of satisfaction
PiLeJe
Industry
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
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