Last updated: March 22, 2022
Sponsor: EuroPharma, Inc.
Overall Status: Terminated
Phase
2
Condition
Mood Disorders
Panic Disorders
Anxiety Disorders
Treatment
N/AClinical Study ID
NCT03463018
EP-1003
EP-02-2017
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 forGeneralized 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 subscaleof 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
Exclusion Criteria:
- Any diagnosed DSM-IV Axis II disorder
- Current DSM IV Axis I diagnosis of Major Depressive Disorder in the 6 month thatprecede 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 infarctionwithin 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 Concurrenttranquilizer, 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 ofcontraception (e.g., condoms, oral contraceptives, etc)
- Any other condition that precludes participation according to the judgement of theinvestigator
Study Design
Total Participants: 100
Study Start date:
June 06, 2018
Estimated Completion Date:
December 15, 2021
Study Description
Connect with a study center
Simon Skechinashvili University Hospital
Tbilisi,
GeorgiaSite Not Available

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