A Pilot Grant to Examine the Feasibility, Efficacy and Tolerability of a Standardized Chamomile Extract in Treating Chronic Primary Insomnia
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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
Intervention: Chamomile High Grade Extract (Dietary Supplement)
Placebo Tablet
Contained lactose
Intervention: Placebo Tablet (Drug)
Outcomes
Primary Outcomes
Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.
Time Frame: baseline and 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).
Secondary Outcomes
- Change From Baseline of Chamomile on Daytime Functioning Measures: BDI(baseline and day 28)
- Change From Baseline of Chamomile on Daytime Functioning Measures: STAI(Baseline and 28 days)
- Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale(Baseline and 28 days)
- Change From Baseline of Chamomile on Daytime Functioning Measures [ Time Frame: Baseline and Day 28 ](Baseline and 28 days)
- Changes From Baseline in the Safety and Tolerability of Chamomile(once per week during study and day 28)
Investigators
Suzanna Zick
Research Associate Professor
University of Michigan