Echinacea Angustifolia (AnxioCalm) in Anxiety

Sponsor

EuroPharma, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT03463018

Collaborator

Simon Khechinashvili University (Other)

100

Enrollment

Location

Arms

42.3

Actual Duration (Months)

2.4

Patients Per Site Per Month

Study Details

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

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 :

Jun 6, 2018

Actual Primary Completion Date :

Oct 3, 2020

Actual Study Completion Date :

Dec 15, 2021

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

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

Hamilton Anxiety Rating (HAM-A) [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) [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

EuroPharma, Inc.

ClinicalTrials.gov Identifier:

NCT03463018

Other Study ID Numbers:

EP-1003
EP-02-2017

First Posted:

Mar 13, 2018

Last Update Posted:

Mar 24, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by EuroPharma, Inc.

Echinacea, Subthreshold Anxiety

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Mar 24, 2022