Clinical trial NCT01286324: Chamomile for Chronic Primary Insomnia
Official title: A Pilot Grant to Examine the Feasibility, Efficacy and Tolerability of a Standardized Chamomile Extract in Treating Chronic Primary Insomnia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Insomnia
Chronic Insomnia
Keywords: Matricaria
Chamomile
Herb
Insomnia
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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.

Primary outcomes:
measure: Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.
timeFrame: baseline and day 28
Secondary outcomes:
measure: Change From Baseline of Chamomile on Daytime Functioning Measures: BDI
timeFrame: baseline and day 28
measure: Change From Baseline of Chamomile on Daytime Functioning Measures: STAI
timeFrame: Baseline and 28 days
measure: Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale
timeFrame: Baseline and 28 days
measure: Change From Baseline of Chamomile on Daytime Functioning Measures [ Time Frame: Baseline and Day 28 ]
timeFrame: Baseline and 28 days
measure: Changes From Baseline in the Safety and Tolerability of Chamomile
timeFrame: once per week during study and day 28
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Department of Family Medicine
state: Michigan
Study officials:
affiliation: University of Michigan
name: Suzanna M Zick, ND, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: J. Todd Arnedt, PhD
role: STUDY_DIRECTOR
References:
citation: Zick SM, Wright BD, Sen A, Arnedt JT. Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study. BMC Complement Altern Med. 2011 Sep 22;11:78. doi: 10.1186/1472-6882-11-78.