Chamomile Therapy for Generalized Anxiety Disorder
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Score on Hamilton Anxiety Rating Scale
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
Arms & Interventions
2
Anxiolytic Therapy
Intervention: Placebo (Other)
1
Chamomile Extract
Intervention: Chamomile Extract (Dietary Supplement)
Outcomes
Primary Outcomes
Score on Hamilton Anxiety Rating Scale
Time Frame: 8 Weeks
Secondary Outcomes
- Beck Anxiety Index Rating(8 Weeks)