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

NCT02981238 | Completed

• 1 other identifier: PiL-Obs-SLEE-PI-015
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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)

Conditions

Sleep Disorders Related to Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evolution of Hamilton Anxiety Scale (HAM-A)

  day 0 and day 28

• Percentage of Satisfaction

  day 28

Interventions

Phytostandard® Eschscholtzia / Valerian DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients suffering from sleep disorders linked to anxiety

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• PiLeJe: lead

Study Sites (1)

Pileje Network of general practitioners

Paris, 75000, France

Location

MeSH Terms

Interventions

Valeriana extract

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2016
• First Posted: December 5, 2016
• Study Start: September 20, 2016
• Primary Completion: January 12, 2017
• Study Completion: January 12, 2017
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

FR (1)