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NCT01072344 · ClinicalTrials.gov registry record · Phase 3
Long Term Chamomile Therapy for Anxiety
A Phase 3 study of Generalized Anxiety Disorder, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 3
- Development phase
- 180
- Enrollment target
- 1
- Study location
NCT01072344: Completed Phase 3 study of Generalized Anxiety Disorder, sponsored by University of Pennsylvania.
NCT01072344 is a Phase 3 study of Generalized Anxiety Disorder that has completed, run by University of Pennsylvania. The registered enrollment target is 180 participants, below the 211-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (15% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01072344, a Phase 3 study of Generalized Anxiety Disorder, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 180 participants
- Enrollment target
- 1
- Study location
Study Summary
Prior research has shown that chamomile may be an effective, short-term anti-anxiety treatment. This study will examine the initial and long-term benefits of chamomile extract therapy for the prevention of recurrent anxiety disorder.
Primary Outcome
The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Relapse is dichotomously defined as an increase in CGI/S (a clinician-rated global measure of anxiety's severity) score from ≤ 3 (at study visit 6) to ≥ 4 (on two consecutive scheduled or unscheduled study visits ≥ 2 weeks apart) plus meeting DSM IV-TR criteria for GAD (minus the 6-month time criterion).
Conditions Studied
Interventions
- DRUG Chamomile (Matricaria recutita)
Study Locations (1)
Pennsylvania
- Depression Research Unit - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2010-02 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
What the finished NCT01072344 record still lists
NCT01072344 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 211-participant average among 48 other Generalized Anxiety Disorder trials with a reported enrollment target (15% lower).
The record links to 1 condition, with Generalized Anxiety Disorder appearing as the primary indexed condition, and to 1 intervention - of which Chamomile (Matricaria recutita) is the first listed.
NCT01072344 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01072344 about?
NCT01072344 is a clinical study titled "Long Term Chamomile Therapy for Anxiety". Prior research has shown that chamomile may be an effective, short-term anti-anxiety treatment. This study will examine the initial and long-term benefits of chamomile extract therapy for the prevention of recurrent anxiety disorder.
What is the current status of trial NCT01072344?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2010-02. Estimated completion is 2015-06.
What conditions does trial NCT01072344 study?
This clinical trial studies the following conditions: Generalized Anxiety Disorder.
What interventions are being tested in trial NCT01072344?
The interventions under investigation include: Chamomile (Matricaria recutita) (DRUG).
Who is sponsoring clinical trial NCT01072344?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01072344 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01072344's enrollment target sits among peer trials
180 19th of 48 higher than 28 of 48 other Generalized Anxiety Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Generalized Anxiety Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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