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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
34
three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days
University of Michigan Department of Family Medicine
Ann Arbor, Michigan, United States
Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.
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).
Time frame: baseline and day 28
Change From Baseline of Chamomile on Daytime Functioning Measures: BDI
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), which is scored on a scale of 0 to 63 where a total score of 0-13 is considered minimal range (minimal depression), 14-19 is mild, 20-28 is moderate, and 29-63 is severe.
Time frame: baseline and day 28
Change From Baseline of Chamomile on Daytime Functioning Measures: STAI
Change From Baseline of Chamomile on Daytime Functioning Measures, depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II) and trait portrait of the State Trait Anxiety Index (STAI). STAI scores range for each subtest from 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale
Time frame: Baseline and 28 days
Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale
Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale (FSS) Range: 9 to 63. The 9-item scale measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders. The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.
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Time frame: Baseline and 28 days
Change From Baseline of Chamomile on Daytime Functioning Measures [ Time Frame: Baseline and Day 28 ]
the change from baseline of global QOL (as determined by the 12 Item Short Form Health Survey Version 2 {SF-12 V2})
Time frame: Baseline and 28 days
Changes From Baseline in the Safety and Tolerability of Chamomile
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 were measured by counting all participants who reported a serious or non-serious adverse event at the weekly check-ins that were established.
Time frame: once per week during study and day 28