Echinacea Angustifolia (AnxioCalm) in Anxiety

NCT ID: NCT03463018

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-06
• Study Completion Date: 2021-12-15

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Echinacea angustifolia

Intervention Type: DIETARY_SUPPLEMENT

20 mg tablet of Echinacea angustifolia, standardized for echinacoside (not less than 3%) and alkamides (not less than 0.8%)

Placebo

Identical excipients as in the experimental arm, without the active ingredient

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Placebo tablet containing matching excipients to the active intervention

Interventions

Echinacea angustifolia

20 mg tablet of Echinacea angustifolia, standardized for echinacoside (not less than 3%) and alkamides (not less than 0.8%)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Placebo tablet containing matching excipients to the active intervention

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Simon Khechinashvili University

UNKNOWN

Sponsor Role: collaborator

EuroPharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marina Janelidze, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Simon Khechinashvili University Hospital, I.Chavchavadze 33, 0162, Tbilisi, Georgia

Locations

Simon Skechinashvili University Hospital

Tbilisi, , Georgia

Countries

Georgia

Other Identifiers

EP-02-2017

Identifier Type: OTHER

Identifier Source: secondary_id

EP-1003

Identifier Type: -

Identifier Source: org_study_id