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Chamomile Therapy for Generalized Anxiety

This study has been completed.
Sponsor:
Collaborators:
National Center for Complementary and Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00645983
First received: March 26, 2008
Last updated: December 1, 2009
Last verified: December 2009
History of Changes
  Purpose

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
Generalized Anxiety Disorder
 Dietary Supplement: Chamomile Extract
Other: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chamomile Therapy for Generalized Anxiety Disorder

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
Drug Information available for: Chamomile
U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Score on Hamilton Anxiety Rating Scale [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Anxiety Index Rating [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]

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
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00645983

Locations
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 Alternative Medicine (NCCAM)
Office of Dietary Supplements (ODS)
Investigators
Principal Investigator: Jay D. Amsterdam, M.D. University of Pennsylvania
  More Information

No publications provided by University of Pennsylvania

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jay D. Amsterdam, M.D., Professor, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00645983     History of Changes
Other Study ID Numbers: R21 AT001916, R21AT001916
Study First Received: March 26, 2008
Last Updated: December 1, 2009
Health Authority: United States: Federal Government

Keywords provided by University of Pennsylvania:
Chamomile
Anxiety
Complementary and Alternative Medicine

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013