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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 : Completed
First Posted : March 13, 2018
Last Update Posted : July 3, 2019
Simon Khechinashvili University
Information provided by (Responsible Party):
EuroPharma, Inc.

Tracking Information
First Submitted Date  ICMJE March 2, 2018
First Posted Date  ICMJE March 13, 2018
Last Update Posted Date July 3, 2019
Actual Study Start Date  ICMJE June 6, 2018
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 9, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03463018 on Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Echinacea Angustifolia (AnxioCalm) in Anxiety
Official Title  ICMJE 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
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Dietary Supplement: Echinacea angustifolia
    20 mg tablet of Echinacea angustifolia, standardized for echinacoside (not less than 3%) and alkamides (not less than 0.8%)
  • Dietary Supplement: Placebo
    Placebo tablet containing matching excipients to the active intervention
Study Arms  ICMJE
  • 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
    Intervention: Dietary Supplement: Echinacea angustifolia
  • Placebo Comparator: Placebo
    Identical excipients as in the experimental arm, without the active ingredient
    Intervention: Dietary Supplement: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 9, 2018)
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 15, 2019
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Georgia
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT03463018
Other Study ID Numbers  ICMJE EP-1003
EP-02-2017 ( Other Identifier: Sponsor )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party EuroPharma, Inc.
Study Sponsor  ICMJE EuroPharma, Inc.
Collaborators  ICMJE Simon Khechinashvili University
Investigators  ICMJE
Principal Investigator: Marina Janelidze, PhD MD Simon Khechinashvili University Hospital, I.Chavchavadze 33, 0162, Tbilisi, Georgia
PRS Account EuroPharma, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP