Phytotherapy Strategy for Sleep Disorders Related to Anxi... | NCT02981238

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

NCT02981238

Sponsor

PiLeJe

Status

Completed

Last Update Posted

Jul 17, 2018Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Sleep Disorders Related to Anxiety

Interventions

Phytostandard® Eschscholtzia / Valerian

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 20, 2016Actual

Primary Completion Date

Jan 12, 2017Actual

Completion Date

Jan 12, 2017Actual

First Submitted Date

Nov 22, 2016

First Submission Date that Met QC Criteria

Dec 2, 2016

First Posted Date

Dec 5, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2018

Last Update Posted Date

Jul 17, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Name	Type	Description	Arm Group Labels	Other Names
Phytostandard® Eschscholtzia / Valerian	Dietary Supplement

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

Patients suffering from sleep disorders linked to anxiety

Sampling Method

Probability Sample