Echinacea Angustifolia (AnxioCalm) in Anxiety

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

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.

Study Overview

• Status: Terminated
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Dietary supplement: Echinacea angustifolia; Dietary supplement: 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: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia
    • Simon Skechinashvili University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hamilton Anxiety Rating (HAM-A)	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.	14 days
State-Trait Anxiety Inventory (STAI)	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.	14 days

Collaborators and Investigators

• Sponsor: EuroPharma, Inc.
• Collaborators: Simon Khechinashvili University
• Investigators: Principal Investigator: Marina Janelidze, PhD MD, Simon Khechinashvili University Hospital, I.Chavchavadze 33, 0162, Tbilisi, Georgia

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Actual): October 3, 2020
• Study Completion (Actual): December 15, 2021

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Echinacea, Subthreshold Anxiety
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: EP-1003; EP-02-2017 (Other Identifier: Sponsor)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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