Chamomile for Chronic Primary Insomnia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Suzanna Zick, University of Michigan
ClinicalTrials.gov Identifier:
NCT01286324
First received: January 24, 2011
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine if an herb called chamomile can help to treat insomnia (difficulty in going to sleep or getting enough sleep) by increasing the amount of time that you sleep and/or improving the quality of your sleep. The study will also be looking at the effect of chamomile on day time fatigue and functioning.


Condition Intervention Phase
Primary Insomnia
Chronic Insomnia
Dietary Supplement: Chamomile High Grade Extract
Drug: Placebo Tablet
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Grant to Examine the Feasibility, Efficacy and Tolerability of a Standardized Chamomile Extract in Treating Chronic Primary Insomnia

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28. [ Time Frame: baseline and day 28 ] [ Designated as safety issue: Yes ]

    Change from baseline of chamomile extract, three tablets (equivalent to 7.5 g of dried herb) p.o. twice times daily versus placebo on the following sleep measures at 28 days:

    • the change from baseline of daily self-report of sleep as assessed by a sleep diary that includes determination of: (i) sleep efficiency, which equals "The total sleep time divided by time-in-bed, multiplied by 100." This measure is our primary aim (SE); Secondary aims include - (ii) total sleep time (TST); (iii) sleep-onset latency (SOL); (iv) and sleep quality (SQ);
    • the change from baseline of global sleep and insomnia symptoms as determined by the (i) Pittsburg Sleep Quality Index (PSQI); and (ii) Insomnia Severity Index (ISI);


Secondary Outcome Measures:
  • To Determine the Change From Baseline of Chamomile on Daytime Functioning Measures [ Time Frame: baseline and day 28 ] [ Designated as safety issue: No ]

    Change from baseline of chamomile extract, three tablets p.o. twice times daily versus placebo on daytime functioning measures at 28 days:

    • the change from baseline of measures of depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II) and trait portrait of the State Trait Anxiety Index (STAI);
    • the change from baseline of fatigue as determined by the Fatigue Severity Scale of Sleep Disorders (FSS);
    • the change from baseline of global QOL (as determined by the 12 Item Short Form Health Survey Version 2 {SF-12 V2})

  • To Evaluate Any Changes From Baseline in the Safety and Tolerability of Chamomile [ Time Frame: once per week during study and day 28 ] [ Designated as safety issue: Yes ]
    To evaluate any changes from baseline in the safety and tolerability of Chamomile High Grade Extract, three tablets (equivalent to 7.5g of dried herb) p.o. twice times daily versus placebo.


Enrollment: 34
Study Start Date: July 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chamomile High Grade Extract
Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
Dietary Supplement: Chamomile High Grade Extract
three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days
Placebo Comparator: Placebo Tablet
Contained lactose
Drug: Placebo Tablet

Detailed Description:

Insomnia, defined as the inability to initiate or maintain sleep or lack of restorative sleep, is the most prevalent sleep complaint in primary care. Insomnia is associated with decreased quality of life, work limitations and increased healthcare utilization. Currently there is no treatment for chronic insomnia that is readily available, affordable, without significant side-effects and demonstrated to be safe for long term use. Consequently, treatments that would fill this gap are needed.

Chamomile (Matricaria recutita) has been used as a gentle sleep agent by herbalists for several hundred years. It has been studied in animals for its sedative potential and shows promise for treating insomnia. Currently, chamomile's sedative mechanisms of action are unknown, but are thought to be through the major inhibitory neurotransmitter in the central nervous system, γ - aminobutyric acid (GABA). However, no study has examined chamomile's efficacy and safety for treating insomnia.

The investigators propose a double-blind, placebo-controlled, randomized trial of chamomile in primary care patients with chronic insomnia. Thirty-four patients will be randomized to either Chamomile High Grade Extract, three 5 mg tablets standardized to 0.4% (-)-α-bisabolol twice daily or placebo and will be followed for 28 days for changes in a sleep diary (sleep efficiency, total sleep time, sleep-onset latency and sleep quality), insomnia severity and sleep disturbances. Secondary endpoints include assessing changes in day time functioning (measures of global quality of life, depression and anxiety) and monitoring for any signs of toxicity. The investigators will also determine the feasibility of conducting a larger trial with this agent.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women aged 18 to 64 years;
  • Must be able to give written informed consent;
  • Have a diagnosis of primary insomnia per DSM-IV criteria, reporting < 6.5 hours sleep and/or >30 minutes to fall asleep (SOL) and/or wake after sleep onset (WASO) > 30 minutes, three or more nights per week;
  • Present sleep complaint for at least 6 months;

Exclusion Criteria:

  • Women who are pregnant, lactating or less than six months post-partum. Due to the fact that an assessment of reproductive performance and teratology tests have not been conducted we are excluding pregnant and lactating women;
  • Patients with unstable medical conditions;
  • DSM-IV Axis I or personality disorder diagnosis with the exception of patients with treated and stable unipolar depression or generalized anxiety disorder (such that the PRIME-MD scores are within normal range for these disorders);
  • Difficulty in sleep initiation or maintenance associated with known medical diagnosis or conditions that may affect sleep, e.g., sleep apnea, restless leg syndrome, chronic pain;
  • Evidence of lack of reliability or noncompliance as defined by missing a pretreatment appointment more than twice;
  • Current diagnosis of substance abuse or dependence;
  • Known allergy to chamomile or members of the ragweed family;
  • Currently taking cyclosporine, warfarin or chronic sedative and anxiolytic medications;
  • Prior use of insomnia medications is not exclusionary, but patients must be off of these medications at the screening visit and through out the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01286324

Locations
United States, Michigan
University of Michigan Department of Family Medicine
Ann Arbor, Michigan, United States, 48105
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Suzanna M Zick, ND, MPH University of Michigan
Study Director: J. Todd Arnedt, PhD University of Michigan
  More Information

Publications:
Responsible Party: Suzanna Zick, Research Associate Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01286324     History of Changes
Other Study ID Numbers: 101,749
Study First Received: January 24, 2011
Results First Received: January 21, 2013
Last Updated: June 24, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
Matricaria
Chamomile
Herb
Insomnia

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Mental Disorders

ClinicalTrials.gov processed this record on July 09, 2014