Phase 2 N=34 Randomized Quadruple-blind Treatment

Chamomile for Chronic Primary Insomnia

Primary Insomnia · Chronic Insomnia

Bottom Line

View on ClinicalTrials.gov: NCT01286324 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2013

Primary outcome: Primary: Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28. — 83.3; 77.5 percentage of time asleep — p=0.21

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Chamomile High Grade Extract (Dietary_supplement); Placebo Tablet (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Michigan
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.	83.3; 77.5	0.21
SECONDARY Change From Baseline of Chamomile on Daytime Functioning Measures: BDI	6.0; 3.2; 4.8; 2.4	0.60
SECONDARY Change From Baseline of Chamomile on Daytime Functioning Measures: STAI	33.2; 30.8; 33.6; 30.1; 37.5; 36.3	0.47
SECONDARY Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale	30.9; 32.1; 32.3; 27.9	0.11
SECONDARY Change From Baseline of Chamomile on Daytime Functioning Measures [ Time Frame: Baseline and Day 28 ]	—	—
SECONDARY Changes From Baseline in the Safety and Tolerability of Chamomile	10; 6	—

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.

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01286324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.