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

Sleep Disorders Related to Anxiety Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02981238
• Other study ID #: PiL-Obs-SLEE-PI-015
• Status: Completed
• Start date: September 20, 2016
• Est. completion date: January 12, 2017

Study information

• Verified date: July 2018
• Source: Pileje
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: January 12, 2017
• Est. primary completion date: January 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 68 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Parasomnias
• Sleep Disorders Related to Anxiety
• Sleep Wake Disorders

Intervention

Dietary Supplement:
• Phytostandard® Eschscholtzia / Valerian

Locations

Country	Name	City	State
France	Pileje Network of general practitioners	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Pileje

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evolution of Hamilton Anxiety Scale (HAM-A)	This outcome is compared with HAM-A at day 0	day 0 and day 28
Secondary	Percentage of Satisfaction	using a likert scale of satisfaction	day 28