CompletedNCT01286324Updated Nov 7, 2017Results posted

Chamomile for Chronic Primary Insomnia

A Phase 2 interventional study of Chamomile High Grade Extract and Placebo Tablet in Primary Insomnia and Chronic Insomnia, sponsored by University of Michigan. Completed at 1 site in United States. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2017-11-07.

Sponsored by University of Michigan · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 34
Allocation: Randomized
Ages: 18 Years to 64 Years
Sex: All

Study 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.

Read the 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 studied

Primary Insomnia
Chronic Insomnia

Browse trials for

Sleep Initiation and Maintenance Disorders 1,856

Keywords

Matricaria
Chamomile
Herb
Insomnia

In context

Sleep Initiation and Maintenance Disorders

1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.

This study's enrollment of 34 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.

Browse Sleep Initiation and Maintenance Disorders studies →

Lead sponsor

University of Michigan is the lead sponsor of 1,475 studies on the registry; 196 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 128 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 64 Years
Sexes eligible: 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

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 34 participants (actual)

Study arms

Experimental
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
Dietary Supplement: Chamomile High Grade Extract
Placebo comparator
Placebo Tablet
Contained lactose
Drug: Placebo Tablet

Interventions

Dietary supplementChamomile High Grade Extract
three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days
DrugPlacebo Tablet

What researchers measure

Primary outcomes

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

Secondary outcomes

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.
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

Results

Posted Jul 30, 2013

Limitations and caveats

Used subjective sleep measures. We did not assess the characteristics of participants' sleep difficulties and these sleep issues may be important considering the age-range of individuals included in the study

Participant flow

Participant flow — Overall Study
Milestone	Placebo Tablet	Chamomile High Grade Extract
Started	17	17
Completed	17	17
Not completed	0	0

Outcome measures

PrimaryChange 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
Reported as:: Least squares mean · percentage of time asleep

Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.
percentage of time asleep	Placebo Tablet	Chamomile High Grade Extract
Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.	83.3 ± 7.7	77.5 ± 12.9

Statistical analysis

Placebo Tablet vs Chamomile High Grade Extract · t-test, 2 sided · p = 0.21 (Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure)

SecondaryChange 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
Reported as:: Mean · units on a scale

Change From Baseline of Chamomile on Daytime Functioning Measures: BDI
units on a scale	Placebo Tablet	Chamomile High Grade Extract
Pre-treatment	6.0 ± 6.0	3.2 ± 1.6
Post-treatment	4.8 ± 5.0	2.4 ± 2.4

Statistical analysis

Placebo Tablet vs Chamomile High Grade Extract · t-test, 2 sided · p = 0.60 (Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure)

SecondaryChange 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
Reported as:: Mean · units on a scale

Change From Baseline of Chamomile on Daytime Functioning Measures: STAI
units on a scale	Placebo Tablet	Chamomile High Grade Extract
Pre-Treatment State Subscale	33.2 ± 9.7	30.8 ± 8.0
Post-treatment State Subscale	33.6 ± 11.0	30.1 ± 6.8
Pre-Treatment Trait Subscale	37.5 ± 11.3	36.3 ± 10.1
Post-Treatment Trait Subscale	40.8 ± 15.5	35.5 ± 11.0

Statistical analysis

Placebo Tablet vs Chamomile High Grade Extract · t-test, 2 sided · p = 0.47 (Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure)
Placebo Tablet vs Chamomile High Grade Extract · t-test, 2 sided · p = 0.45 (Adjusted p-value based on a general linear model adjusted for group and the baseline of the measure)

SecondaryChange 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.

Time frame:: Baseline and 28 days
Reported as:: Mean · units on a scale

Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale
units on a scale	Placebo Tablet	Chamomile High Grade Extract
Pre-Treatment FSS score	30.9 ± 9.1	32.1 ± 10.6
Post-treatment FSS score	32.3 ± 10.0	27.9 ± 9.3

Statistical analysis

Placebo Tablet vs Chamomile High Grade Extract · t-test, 2 sided · p = 0.11 (P value is adjusted based on a general linear model adjusted for group and the baseline of the measure)

SecondaryChange 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

No measurements were reported for this outcome.

SecondaryChanges 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
Reported as:: Count of participants · Participants

Changes From Baseline in the Safety and Tolerability of Chamomile
Participants	Placebo Tablet	Chamomile High Grade Extract
Changes From Baseline in the Safety and Tolerability of Chamomile	10	6

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Placebo Tablet	—	0/17 (0%)	10/17 (58.8%)
Chamomile High Grade Extract	—	0/17 (0%)	6/17 (35.3%)

Most frequent other events

Most frequent other events
Event	Placebo Tablet	Chamomile High Grade Extract
GI SymptomsGastrointestinal disorders	4/17	2/17
InfectionsInfections and infestations	3/17	2/17
MusculoskeletalMusculoskeletal and connective tissue disorders	2/17	1/17
HeadachesGeneral disorders	1/17	1/17
DizzinessNervous system disorders	1/17	0/17

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Placebo Tablet	Chamomile High Grade Extract	Total
<=18 years	0	0	0
Between 18 and 65 years	17	17	34
>=65 years	0	0	0

Age, Continuous
Age, Continuous(years)	Placebo Tablet	Chamomile High Grade Extract	Total
Mean	40.8 ± 15.3	42.2 ± 13.5	41.4 ± 14.2

Sex: Female, Male
Sex: Female, Male(Participants)	Placebo Tablet	Chamomile High Grade Extract	Total
Female	13	12	25
Male	4	5	9

Region of Enrollment
Region of Enrollment(participants)	Placebo Tablet	Chamomile High Grade Extract	Total
United States	17	17	34

Study locations

1 site

University of Michigan Department of Family Medicine
Ann Arbor, Michigan 48105, United States

References and documents

Publications

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. PubMed 21939549 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01286324
Lead sponsor: University of Michigan
Responsible party: Suzanna Zick (Research Associate Professor, University of Michigan) — Principal investigator
First posted: Jan 31, 2011
Start date: Jul 2008
Primary completion: Dec 2010
Completion: Dec 2010
Results posted: Jul 30, 2013
Last update: Nov 7, 2017

Study contacts

Suzanna M Zick, ND, MPH

principal investigator · University of Michigan

J. Todd Arnedt, PhD

study director · University of Michigan

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Chamomile for Chronic Primary Insomnia

Study summary

Conditions studied

Browse trials for

Keywords

In context

Sleep Initiation and Maintenance Disorders

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria