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Chamomile Therapy for Generalized Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00645983
Recruitment Status : Completed
First Posted : March 28, 2008
Last Update Posted : December 2, 2009
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Information provided by:
University of Pennsylvania

Brief Summary:

This study will determine the effectiveness of chamomile extract for treating generalized anxiety disorder.

Study hypotheses: 1)Chamomile extract will have a superior anti-anxiety effect compared to placebo. 2)Chamomile will have a comparable safety profile to that of placebo.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Dietary Supplement: Chamomile Extract Other: Placebo Phase 4

Detailed Description:
We propose to investigate the anti-anxiety activity of Chamomile. Among the many uses of Chamomile, its use as an anti-anxiety herb is universal. Despite its widespread use and acceptance, there have been no studies evaluating the safety and anti-anxiety efficacy of Chamomile in human subjects. Given this lack of controlled clinical data, we propose a pilot study of Chamomile safety and efficacy in mild anxiety, and propose using the data as a basis for statistically powering a future R01 application. We will ask: Is Chamomile a safe and effective alternative treatment for Generalized Anxiety Disorder (GAD)? To do this, 60 patients with a diagnosis of mild to moderate GAD will receive double-blind treatment for 8 weeks with either (i) Chamomile extract, or (ii) placebo. We hypothesize that Chamomile will have a superior anti-anxiety efficacy compared to placebo, and a comparable safety profile to placebo.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chamomile Therapy for Generalized Anxiety Disorder
Study Start Date : October 2005
Actual Primary Completion Date : January 2008
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: 1
Chamomile Extract
Dietary Supplement: Chamomile Extract
220 mg - 1100 mg daily

Placebo Comparator: 2
Anxiolytic Therapy
Other: Placebo
1 to 5 capsules daily

Primary Outcome Measures :
  1. Score on Hamilton Anxiety Rating Scale [ Time Frame: 8 Weeks ]

Secondary Outcome Measures :
  1. Beck Anxiety Index Rating [ Time Frame: 8 Weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Men and women > 18 years of age (all races and ethnicity)

Meet DSM IV criteria for GAD

Mild to moderate symptom severity

HAM-A score > 8

Not receiving anti-anxiety medication (e.g., benzodiazepine, venlafaxine, buspirone, or SSRI)

Able to understand and provide signed informed consent

Able to participate in a 8-week study

Exclusion Criteria:

Patients < 18 years old

Current DSM IV Axis I diagnosis of Major Depressive Disorder, Bipolar Disorder, Panic Disorder (with or without agoraphobia), Specific Phobia Disorder, Obsessive-Compulsive Disorder, Posttraumatic Stress Disorder, Acute Stress Disorder, Substance-Induced Anxiety Disorder, Schizophrenia, Other psychotic disorders, Current alcohol or drug abuse, Alcohol or drug dependence within 3 months, [NB: Patients with co-morbid DSM IV Axis I Depressive Disorders NOS (e.g., minor depressive disorder, premenstrual dysphoric disorder, and recurrent brief depressive disorder will not be excluded)]

Unstable medical condition (e.g., hypothyroidism, hypertension, myocardial infarction within 1 month, neoplastic condition)

Allergy to Chamomile preparation

Allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum)

Allergy to mugwort, RAST, or birch tree pollen

Concurrent tranquilizer, antidepressant or mood stabilizer therapy

Concurrent use of over-the-counter anti-anxiety and/or antidepressant preparations (e.g., Chamomile, St. John's Wort, Kava kava)

Women of child-bearing potential not willing to employ a medically proven form of contraception (e.g., condoms, oral contraceptives, etc)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00645983

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United States, Pennsylvania
Depression Research Unit, Universityof Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104-3309
Sponsors and Collaborators
University of Pennsylvania
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
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Principal Investigator: Jay D. Amsterdam, M.D. University of Pennsylvania
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jay D. Amsterdam, M.D., Professor, University of Pennsylvania Identifier: NCT00645983    
Other Study ID Numbers: R21AT001916 ( U.S. NIH Grant/Contract )
R21AT001916 ( U.S. NIH Grant/Contract )
First Posted: March 28, 2008    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009
Keywords provided by University of Pennsylvania:
Complementary and Alternative Medicine
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders