Chamomile for Chronic Primary Insomnia

NCT01286324 | Completed Phase 2 Results

• 1 other identifier: 101,749
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Insomnia; Chronic Insomnia

Keywords

Matricaria; Chamomile; Herb; Insomnia

Outcome Measures

Primary Outcomes (1)

• 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).

  baseline and day 28

Secondary Outcomes (5)

• 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

Study Arms (2)

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

Dietary Supplement: Chamomile High Grade Extract

Placebo Tablet

PLACEBO COMPARATOR

Contained lactose

Drug: Placebo Tablet

Interventions

Chamomile High Grade Extract DIETARY_SUPPLEMENT

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

Chamomile High Grade Extract

Placebo Tablet DRUG

Placebo Tablet

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Department of Family Medicine

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (1)

• 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.

  PMID: 21939549 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

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

Results Point of Contact

• Title: Suzanna M Zick
• Organization: University of Michigan

szick@umich.edu

734-998-9553

Study Officials

• Suzanna M Zick, ND, MPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

• J. Todd Arnedt, PhD

  University of Michigan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: January 24, 2011
• First Posted: January 31, 2011
• Study Start: July 1, 2008
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: November 7, 2017
• Results First Posted: July 30, 2013

Record last verified: 2017-10

Locations

US (1)