Long Term Chamomile Therapy for Anxiety
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01072344 |
Recruitment Status :
Completed
First Posted : February 22, 2010
Results First Posted : July 6, 2017
Last Update Posted : July 6, 2017
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Generalized Anxiety Disorder | Drug: Chamomile (Matricaria recutita) | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 180 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Long-Term Chamomile Therapy for Generalized Anxiety Disorder (GAD) |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |
Arm | Intervention/treatment |
---|---|
Experimental: Chamomile Extract
Pharmaceutical grade oral chamomile extract.
|
Drug: Chamomile (Matricaria recutita)
500 mg 3 times daily
Other Name: Chamomile |
Placebo Comparator: Placebo
Pharmaceutical grade lactose monohydrate.
|
Drug: Chamomile (Matricaria recutita)
500 mg 3 times daily
Other Name: Chamomile |
- Time to Relapse in Each Treatment Condition. [ Time Frame: 26 weeks ]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).
- The Proportion of Subjects in Each Treatment Condition Who Relapse. [ Time Frame: 26 weeks ]The proportion of subjects in each treatment condition who relapsed after randomization
- Frequency, Severity, and Duration of Treatment-emergent Adverse Events. [ Time Frame: 26 weeks ]We will report the frequency, severity, and duration of treatment-emergent adverse events by treatment arm.
- Frequency of Discontinuation Symptoms at the Start of Double-blind Therapy in Each Treatment Condition. [ Time Frame: 26 weeks ]Discontinuation emergent signs and symptoms checklist (DESS) is a patient-rated measure of the presence and severity of discontinuation symptoms occurring after medication discontinuation. %
- Frequency of Early Study Discontinuation in Each Treatment Condition. [ Time Frame: 26 weeks ]This is the # of subjects who discontinued the study during randomization phase due to other reasons.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01072344
United States, Pennsylvania | |
Depression Research Unit | |
Philadelphia, Pennsylvania, United States, 19104-3309 |
Principal Investigator: | Jun J Mao, MD | University of Pennsylvania |
Responsible Party: | University of Pennsylvania |
ClinicalTrials.gov Identifier: | NCT01072344 |
Other Study ID Numbers: |
AT005074 |
First Posted: | February 22, 2010 Key Record Dates |
Results First Posted: | July 6, 2017 |
Last Update Posted: | July 6, 2017 |
Last Verified: | June 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Anxiety Chamomile Herbal Remedy Complementary and Alternative Medicine |
Anxiety Disorders Mental Disorders |