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Sponsors and Collaborators: |
National Center for Complementary and Alternative Medicine (NCCAM) Office of Dietary Supplements (ODS) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | NCT00645983 |
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 | Intervention | Phase |
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Generalized Anxiety Disorder |
Dietary Supplement: Chamomile Extract Other: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Chamomile Therapy for Generalized Anxiety Disorder |
Enrollment: | 61 |
Study Start Date: | October 2005 |
Study Completion Date: | January 2008 |
Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Chamomile Extract
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Dietary Supplement: Chamomile Extract
220 mg - 1100 mg daily
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2: Placebo Comparator
Anxiolytic Therapy
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Other: Placebo
1 to 5 capsules daily
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
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)
United States, Pennsylvania | |
Depression Research Unit, Universityof Pennsylvania School of Medicine | |
Philadelphia, Pennsylvania, United States, 19104-3309 |
Principal Investigator: | Jay D. Amsterdam, M.D. | University of Pennsylvania |
Responsible Party: | University of Pennsylvania ( Jay D. Amsterdam, M.D., Professor ) |
Study ID Numbers: | R21 AT001916 |
Study First Received: | March 26, 2008 |
Last Updated: | March 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00645983 History of Changes |
Health Authority: | United States: Federal Government |
Chamomile Anxiety Complementary and Alternative Medicine |
Anxiety Disorders Chamomile Mental Disorders |
Pathologic Processes Disease Anxiety Disorders Mental Disorders |