Echinacea Angustifolia (AnxioCalm) in Anxiety

Last updated: March 22, 2022
Sponsor: EuroPharma, Inc.
Overall Status: Terminated

Phase

2

Condition

Mood Disorders

Panic Disorders

Anxiety Disorders

Treatment

N/A

Clinical Study ID

NCT03463018
EP-1003
EP-02-2017
  • Ages > 18
  • All Genders

Study Summary

This study evaluates whether Echinacea angustifolia (AnxioCalm) is a safe and effective treatment for mild to moderate Generalized Anxiety Disorder (GAD) symptoms. Half the participants will receive Echinacea angustifolia and half will receive placebo.

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

Echinacea angustifolia root extract (AnxioCalm), standardized for the content of echinacoside and its alkamide profile, is intended to be used for 'amelioration of sub-threshold and mild anxiety which are risk factors in the development of Generalized Anxiety Disorder (GAD) and depression' in symptomatic people 'who are not eligible for anxiolytic medication.' Existing medical interventions, which require long periods of repeated administration, have significant safety concerns.

Connect with a study center

  • Simon Skechinashvili University Hospital

    Tbilisi,
    Georgia

    Site Not Available

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