NCT00645983

Chamomile Therapy for Generalized Anxiety

Chamomile Therapy for Generalized Anxiety Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Chamomile Extract	220 mg - 1100 mg daily
OTHER	Placebo	1 to 5 capsules daily

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2008-03-28
• Last updated: 2009-12-02

Locations

1 site across 1 country: United States