NCT00097604

Brief Summary

The purpose of this study is to examine the way valerian, an herbal sleep agent, is absorbed and distributed in the body. This study will also compare the effects of valerian after 1 week versus after 2 weeks.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2004

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2004

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2006

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
Last Updated

July 29, 2010

Status Verified

December 1, 2009

Enrollment Period

1.6 years

First QC Date

November 24, 2004

Last Update Submit

July 28, 2010

Conditions

Sleep Initiation and Maintenance Disorders

Keywords

SleepAgedValerianComplementary TherapiesMedicine, Herbal

Outcome Measures

Primary Outcomes (1)

  • Sleep quality

Study Arms (2)

Valerian

EXPERIMENTAL

This study used a cross-over design with valerian compared to placebo. Group 1 received valerian first followed by placebo after washout and cross-over; group 2 received placebo first followed by placebo after wash-out and cross-over.

Dietary Supplement: Valerian root extract

Placebo

PLACEBO COMPARATOR

This study used a cross-over design with valerian compared to placebo. Group 1 received valerian first followed by placebo after washout and cross-over; group 2 received placebo first followed by placebo after wash-out and cross-over.

Dietary Supplement: Valerian root extract

Interventions

Valerian root extractDIETARY_SUPPLEMENT

Valerian root extract, 100 mg softgels, 3 softgels each night for 2 weeks, 30 minutes before bedtime

Also known as: Valerian
PlaceboValerian

Eligibility Criteria

Age55 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pittsburgh Sleep Quality Instrument score higher than 5
  • Insomnia Severity Index score less than 22
  • At least 5 years past menopause, for female participants

You may not qualify if:

  • Current use of prescribed or over-the-counter sleep medications
  • Plans to move from the area within 2 months of study entry
  • Significant signs and symptoms of sleep apnea; periodic leg movements in sleep (PLMS) associated with arousals; rapid eye movement (REM) behavior disorder; restless legs syndrome; advanced sleep phase syndrome; delayed sleep phase syndrome; or any other sleep disorder, including severe insomnia or a history of chronic insomnia, for which standard therapy would be the treatment of choice
  • Shift work within 6 months prior to study entry
  • Current unusual or highly unstable sleep schedule
  • Trans-meridian travel across more than three time zones within 4 weeks prior to study entry
  • Body mass index between 18 kg/m2 and 32 kg/m2
  • Significant and uncontrolled major illness or psychiatric disease
  • Cognitive impairment
  • Current life stress
  • Use of tobacco within 6 months prior to study entry
  • Excessive use of alcohol or caffeine
  • Currently taking hormone replacement therapy hypnotic or psychotropic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

  • Taibi DM, Vitiello MV, Barsness S, Elmer GW, Anderson GD, Landis CA. A randomized clinical trial of valerian fails to improve self-reported, polysomnographic, and actigraphic sleep in older women with insomnia. Sleep Med. 2009 Mar;10(3):319-28. doi: 10.1016/j.sleep.2008.02.001. Epub 2008 May 14.

    PMID: 18482867RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Valeriana extract

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Carol A. Landis, DNSc

    University of Washington, School of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 24, 2004

First Posted

November 25, 2004

Study Start

September 1, 2004

Primary Completion

April 1, 2006

Study Completion

April 1, 2008

Last Updated

July 29, 2010

Record last verified: 2009-12

Locations

US(1)