Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-25 @ 4:57 AM
NCT ID:
NCT03463018
Eligibility Criteria:
Inclusion Criteria:
* Men and women 18 years of age (all races and ethnicity)
* Meet Diagnostic and Statistical Manual of Mental Disorders (DSM IV) any criteria for Generalized Anxiety Disorder (GAD from 5 to 9)
* mild to moderate symptom severity on the Beck Anxiety Inventory (BAI from 8 to 15)
* Hamilton Anxiety Rating Scale (HAM-A) score from 14 to 17
* Hospital Anxiety and Depression Scale (HADS-A) \[hospital anxiety and depression scale - anxiety subscale\] - 8-10
* Participants score 45-57 points of above on either the state or trait anxiety subscale of the State and Trait Anxiety Inventory of Speilberger (STAI)
* Able to understand and provide signed informed consent
* Able to participate in a 5-week study
Exclusion Criteria:
* Any diagnosed DSM-IV Axis II disorder
* Current DSM IV Axis I diagnosis of Major Depressive Disorder in the 6 month that precede the study. \[to exclude confounding psychiatric factors\]
* Danger of suicidality
* Treatment with Echinacea preparations in the 3 month that precede the study
* Psychotropic medication (especially anxiolytics) in the 3 month that precede the study
* Psychotherapy in the 3 month that precede the study
* Allergic reactions to plants of the Asteraceae family (Echinacea species, etc.)
* Treatment for AIDS or cancer
* Pregnant or lactating women
* Unstable medical condition (e.g., hypothyroidism, hypertension, myocardial infarction within 1 month, neoplastic condition)
* Alcohol or drug dependence within 3 months
* Allergy to Echinacea preparation
* Allergy to plants of the Asteraceae family (e.g., ragweed, asters, chrysanthemum)
* Allergy to mugwort, radioallergosorbent test (RAST), or birch tree pollen Concurrent tranquilizer, antidepressant or mood stabilizer therapy;
* Subjects receiving anti-anxiety medication (e.g., benzodiazepine, venlafaxine, buspirone, or SSRI)
* 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)
* Any other condition that precludes participation according to the judgement of the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03463018
Study Brief:
Protocol Section:
NCT03463018