Clinical trial NCT03463018: Echinacea Angustifolia (AnxioCalm) in Anxiety
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Keywords: Echinacea, Subthreshold Anxiety
Lead sponsor: EuroPharma, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Simon Khechinashvili University
First posted: 2018-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hamilton Anxiety Rating (HAM-A)
timeFrame: 14 days
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Simon Skechinashvili University Hospital
Study officials:
affiliation: Simon Khechinashvili University Hospital, I.Chavchavadze 33, 0162, Tbilisi, Georgia
name: Marina Janelidze, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: