Echinacea Angustifolia (AnxioCalm) in Anxiety

• ClinicalTrials.gov Identifier: NCT03463018
• Recruitment Status: Suspended
• First Posted: March 13, 2018
• Last Update Posted: December 4, 2019
• Sponsor: EuroPharma, Inc.
• Collaborator: Simon Khechinashvili University
• Information provided by (Responsible Party): EuroPharma, Inc.

Study Description

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.

Study Design

• 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
• Estimated Primary Completion Date: October 3, 2020
• Estimated Study Completion Date: December 15, 2020

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Georgia

Simon Skechinashvili University Hospital

Tbilisi, Georgia

Sponsors and Collaborators

EuroPharma, Inc.

Simon Khechinashvili University

Investigators

• Principal Investigator: Marina Janelidze, PhD MD; Simon Khechinashvili University Hospital, I.Chavchavadze 33, 0162, Tbilisi, Georgia

More Information

• Responsible Party: EuroPharma, Inc.
• ClinicalTrials.gov Identifier: NCT03463018
• Other Study ID Numbers: EP-1003; EP-02-2017 ( Other Identifier: Sponsor )
• First Posted: March 13, 2018
• Last Update Posted: December 4, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

Anxiety Disorders; Mental Disorders