Chamomile Therapy for Generalized Anxiety

December 1, 2009 updated by: University of Pennsylvania

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-3309
        • Depression Research Unit, Universityof Pennsylvania School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Anxiolytic Therapy
Other: Placebo
1 to 5 capsules daily
Experimental: 1
Chamomile Extract
Dietary supplement: Chamomile Extract
220 mg - 1100 mg daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Score on Hamilton Anxiety Rating Scale
Time Frame: 8 Weeks
8 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Beck Anxiety Index Rating
Time Frame: 8 Weeks
8 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

National Center for Complementary and Integrative Health (NCCIH)
Office of Dietary Supplements (ODS)

Investigators

  • Principal Investigator: Jay D. Amsterdam, M.D., University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2005

Primary Completion (Actual)

January 1, 2008

Study Completion (Actual)

January 1, 2008

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 26, 2008

First Posted (Estimate)

March 28, 2008

Study Record Updates

Last Update Posted (Estimate)

December 2, 2009

Last Update Submitted That Met QC Criteria

December 1, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT001916 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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