Trial record 2 of 2 for:    Chamomile | NCCAM

Chamomile Therapy for Generalized Anxiety

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00645983
First received: March 26, 2008
Last updated: December 1, 2009
Last verified: December 2009

March 26, 2008
December 1, 2009
October 2005
January 2008   (final data collection date for primary outcome measure)
Score on Hamilton Anxiety Rating Scale [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00645983 on ClinicalTrials.gov Archive Site
Beck Anxiety Index Rating [ Time Frame: 8 Weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Chamomile Therapy for Generalized Anxiety
Chamomile Therapy for Generalized Anxiety Disorder

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Generalized Anxiety Disorder
  • Dietary Supplement: Chamomile Extract
    220 mg - 1100 mg daily
  • Other: Placebo
    1 to 5 capsules daily
  • Experimental: 1
    Chamomile Extract
    Intervention: Dietary Supplement: Chamomile Extract
  • Placebo Comparator: 2
    Anxiolytic Therapy
    Intervention: Other: Placebo
Amsterdam JD, Li Y, Soeller I, Rockwell K, Mao JJ, Shults J. A randomized, double-blind, placebo-controlled trial of oral Matricaria recutita (chamomile) extract therapy for generalized anxiety disorder. J Clin Psychopharmacol. 2009 Aug;29(4):378-82.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
January 2008
January 2008   (final data collection date for primary outcome measure)

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)

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00645983
R21 AT001916, R21AT001916
Yes
Jay D. Amsterdam, M.D., Professor, University of Pennsylvania
University of Pennsylvania
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • Office of Dietary Supplements (ODS)
Principal Investigator: Jay D. Amsterdam, M.D. University of Pennsylvania
University of Pennsylvania
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP