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Echinacea Angustifolia (AnxioCalm) in 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. Identifier: NCT03463018
Recruitment Status : Terminated (Recruitment error; Inclusion criteria not met)
First Posted : March 13, 2018
Last Update Posted : March 24, 2022
Simon Khechinashvili University
Information provided by (Responsible Party):
EuroPharma, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Dietary Supplement: Echinacea angustifolia Dietary Supplement: Placebo Phase 2

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: A Phase 2 Randomized, Double-Blind, Parallel-Group, Placebo Controlled Fixed-Dose Study of Echinacea Angustifoliae Root Extract (AnxioCalm) in Healthy Subjects With Subthreshold Symptoms of Anxiety
Actual Study Start Date : June 6, 2018
Actual Primary Completion Date : October 3, 2020
Actual Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
Drug Information available for: Echinacea

Arm Intervention/treatment
Experimental: Echinacea angustifolia
20 mg tablet of Echinacea angustifolia root extract standardized for a specific alkamide profile, two tablets twice daily (total daily dose of 80 mg) for two weeks
Dietary Supplement: Echinacea angustifolia
20 mg tablet of Echinacea angustifolia, standardized for echinacoside (not less than 3%) and alkamides (not less than 0.8%)

Placebo Comparator: Placebo
Identical excipients as in the experimental arm, without the active ingredient
Dietary Supplement: Placebo
Placebo tablet containing matching excipients to the active intervention

Primary Outcome Measures :
  1. Hamilton Anxiety Rating (HAM-A) [ Time Frame: 14 days ]
    The Hamilton Anxiety Rating Scale (HAM-A) is a physician rating scale consisting of 14 items measuring psychic and somatic anxiety. Each item is scored on a scale of 0 (none) to 4 (severe) where a total score of 14-17 = Mild Anxiety, 18-24 = Moderate Anxiety, 25-30 = Severe Anxiety. The primary outcome is the change over time in the baseline HAM-A score rating for AnxioCalm versus placebo.

  2. State-Trait Anxiety Inventory (STAI) [ Time Frame: 14 days ]
    The State-Trait Anxiety Inventory (Form Y, 6 item) is a six item patient rating scale consisting of anxiety present and anxiety absent items. Each item is rated from 1 (not at all) to 4 (very much). For scoring, positive items (calm, relaxed, content) are reverse scored [1=4, 2=3, 3=2, 4=1], the six scores are totaled, and multiplied by 20/6. A normal score is approximately 34-36.The primary outcome is the change over time in the baseline STAI score for AnxioCalm versus placebo.

Information from the National Library of Medicine

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03463018

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Simon Skechinashvili University Hospital
Tbilisi, Georgia
Sponsors and Collaborators
EuroPharma, Inc.
Simon Khechinashvili University
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Principal Investigator: Marina Janelidze, PhD MD Simon Khechinashvili University Hospital, I.Chavchavadze 33, 0162, Tbilisi, Georgia
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Responsible Party: EuroPharma, Inc. Identifier: NCT03463018    
Other Study ID Numbers: EP-1003
EP-02-2017 ( Other Identifier: Sponsor )
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 24, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by EuroPharma, Inc.:
Echinacea, Subthreshold Anxiety
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders