Status:
COMPLETED
Chamomile Therapy for Generalized Anxiety
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00645983
Start Date
October 1 2005
End Date
January 1 2008
Last Update
December 2 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Depression Research Unit, Universityof Pennsylvania School of Medicine
Philadelphia, Pennsylvania, United States, 19104-3309