Primary InsomniaPhase 2NCT01286324

Chamomile for Chronic Primary Insomnia

A Phase 2 study testing Chamomile High Grade Extract in people with Primary Insomnia and Chronic Insomnia, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Primary Insomnia, Chronic Insomnia
What is being tested?: Chamomile High Grade Extract
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 34 participants
Where: 1 siteUnited States
Study dates: Jul 2008to Dec 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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;

Who cannot join

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;

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

Official title: A Pilot Grant to Examine the Feasibility, Efficacy and Tolerability of a Standardized Chamomile Extract in Treating Chronic Primary Insomnia

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: Primary Insomnia, Chronic Insomnia
Being tested: Chamomile High Grade Extract, Placebo Tablet
Keywords: Matricaria, Chamomile, Herb, Insomnia
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Chamomile High Grade ExtractDietary supplement
three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days
Placebo TabletDrug

Study groups in NCT01286324
Study group	Role	What they receive
Chamomile High Grade Extract	Experimental	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 Receives: Dietary Supplement: Chamomile High Grade Extract
Placebo Tablet	Placebo comparator	Contained lactose Receives: Drug: Placebo Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: baseline and day 28

Secondary outcomes (5)

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.
Measured: 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
Measured: 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.
Measured: 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})
Measured: 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.
Measured: once per week during study and day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2008Dec 2010

First posted31 Jan 2011 (estimated)
Study startJul 2008
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Primary InsomniaStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01286324
Sponsor's protocol ID: 101,749
Status last verified: Oct 2017
First submitted: 24 Jan 2011
Last updated: 7 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Grant to Examine the Feasibility, Efficacy and Tolerability of a Standardized Chamomile Extract in Treating Chronic Primary Insomnia
ClinicalTrials.gov ID: NCT01286324
Acronym / sponsor ID: 101,749
Conditions: Primary Insomnia, Chronic Insomnia
Keywords: Matricaria, Chamomile, Herb, Insomnia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 34 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: Jul 2008
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 31 Jan 2011 (estimated)
Results: Posted 30 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Chamomile High Grade Extract	Experimental	Dietary Supplement: Chamomile High Grade ExtractEach 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
Placebo Tablet	Placebo comparator	Drug: Placebo TabletContained lactose

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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;

Key exclusion criteria (9 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Chamomile High Grade Extractthree tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days	Dietary supplement	Chamomile High Grade Extract
Placebo Tablet	Drug	Placebo Tablet

Primary outcome

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).

5 secondary outcomes

Change From Baseline of Chamomile on Daytime Functioning Measures: BDI
Time frame: baseline and day 28
Change From Baseline of Chamomile on Daytime Functioning Measures: STAI
Time frame: Baseline and 28 days
Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale
Time frame: Baseline and 28 days
Change From Baseline of Chamomile on Daytime Functioning Measures [ Time Frame: Baseline and Day 28 ]
Time frame: Baseline and 28 days
Changes From Baseline in the Safety and Tolerability of Chamomile
Time frame: once per week during study and day 28

Results and safety

Results posted to the registry on 30 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Tablet	17	17
Chamomile High Grade Extract	17	17

Primary outcome: Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.

Time frame: baseline and day 28. Least squares mean (Standard Deviation). Unit: percentage of time asleep

Measure	Placebo Tablet n = 17	Chamomile High Grade Extract n = 17
Value	83.3 (7.7)	77.5 (12.9)

Placebo Tablet vs Chamomile High Grade Extract: p = 0.21, t-test, 2 sided

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Tablet	0 of 17 (0%)	10 of 17 (58.8%)	Not reported
Chamomile High Grade Extract	0 of 17 (0%)	6 of 17 (35.3%)	Not reported

Limitations and caveats (from the sponsor): 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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21939549Zick 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Suzanna M Zick, ND, MPH principal investigator

University of Michigan

J. Todd Arnedt, PhD study director

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Chamomile High Grade Extract in people with Primary Insomnia and Chronic Insomnia, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28. (time frame: baseline and day 28). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01286324, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.