Chamomile for Chronic Primary Insomnia

NCT ID: NCT01286324

Last Updated: 2017-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-12-31

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.

Conditions

Primary Insomnia; Chronic Insomnia

Keywords

Matricaria; Chamomile; Herb; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Chamomile High Grade Extract

Intervention Type: DIETARY_SUPPLEMENT

three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days

Placebo Tablet

Contained lactose

Group Type: PLACEBO_COMPARATOR

Placebo Tablet

Intervention Type: DRUG

Interventions

Chamomile High Grade Extract

three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days

Intervention Type: DIETARY_SUPPLEMENT

Placebo Tablet

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Suzanna Zick

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanna M Zick, ND, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

J. Todd Arnedt, PhD

Role: STUDY_DIRECTOR

University of Michigan

Locations

University of Michigan Department of Family Medicine

Ann Arbor, Michigan, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21939549 (View on PubMed)

Other Identifiers

101,749

Identifier Type: -

Identifier Source: org_study_id