Phase 3
Completed N=93
Long Term Chamomile Therapy for Anxiety
Source: ClinicalTrials.gov NCT01072344 ↗Enrolled (actual)
93
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Time to Relapse in Each Treatment Condition. — 11.4; 6.3 weeks
◆ Published Evidence
Highly cited
157citations · ~16 / year
Long-term chamomile (Matricaria chamomilla L.) treatment for generalized anxiety disorder: A randomized clinical trial.
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.
Linked Publications (3)
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Long-term chamomile (Matricaria chamomilla L.) treatment for generalized anxiety disorder: A randomized clinical trial.
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Specific expectancies are associated with symptomatic outcomes and side effect burden in a trial of chamomile extract for generalized anxiety disorder.
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An exploratory study of salivary cortisol changes during chamomile extract therapy of moderate to severe generalized anxiety disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Relapse in Each Treatment Condition. |
11.4; 6.3 | — |
| SECONDARY The Proportion of Subjects in Each Treatment Condition Who Relapse. |
7; 12 | — |
| SECONDARY Frequency, Severity, and Duration of Treatment-emergent Adverse Events. |
8; 9 | — |
| SECONDARY Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition. |
31; 33; 14; 11 | — |
| SECONDARY Frequency of Early Study Discontinuation in Each Treatment Condition. |
3; 4; 1; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women at least 18 years old (all races and ethnicity)
- DSM IV diagnosis of GAD as the primary anxiety disorder
- Baseline GAD-7 score ≥ 10
- Baseline CGI/S score at least 4
- Not taking anti-anxiety medication (e.g., Benzodiazepines, buspirone, antidepressants)
- Not taking antidepressant, mood stabilizer, or tranquilizer therapy for a prior DSM IV Axis I mood disorder that is in remission
- Able to understand and provide informed consent
- Able to participate in a 38-week study
Exclusion Criteria
- Patients < 18 years old
- Primary DSM IV Axis I anxiety disorder other than GAD (e.g., panic disorder with or without agoraphobia, phobia disorder, acute stress disorder, social anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, substance-induced anxiety disorder)
- Current DSM IV Axis I psychotic disorder
- Substance abuse or dependence within the prior 3 months
- Current DSM IV Axis I bipolar or major depressive disorder [Note: Patients with co-morbid depressive disorder NOS (e.g., minor depression, recurrent brief depressive disorder, or premenstrual dysphoric disorder (PMDD)] will not be excluded
- Unstable medical condition
- Allergy to chamomile
- Documented allergy to plants of the asteraceae family (e.g., ragweed, asters, chrysanthemum)
- Allergic to mugwort or birch pollen
- Concurrent anti-anxiety 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)
- Concurrent use of established antidepressant, mood stabilizer, or tranquilizer therapy for pre-existing affective disorder. [Note: Patients with a history of affective disorder (in remission) who are not currently taking antidepressant, mood stabilizer, or tranquilizer therapy are not excluded from the trial]
- Women of child-bearing potential not willing to use a medically proven form of contraception
- Positive pregnancy test
- Actively suicidal or suicide attempt within the preceding 12 months
Data sourced from ClinicalTrials.gov (NCT01072344) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.