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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Sleep Disorders Related to Anxiety

Intervention / Treatment
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* Dietary Supplement: Phytostandard® Eschscholtzia / Valerian


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Phytostandard® Eschscholtzia / Valerian|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evolution of the Index of Severity of Insomnia (ISI) | 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) | This outcome is compared with HAM-A at day 0 | day 0 and day 28 | 
| Percentage of Satisfaction | using a likert scale of satisfaction | day 28 |