Trial | NCT03463018  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    100
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.
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 Started
Jun 06
2018
Primary Completion
Oct 03
2020
Study Completion
Dec 15
2021
Last Update
Mar 24
2022

Dietary Supplement Echinacea angustifolia

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

Dietary Supplement Placebo

Placebo tablet containing matching excipients to the active intervention

Echinacea angustifolia Experimental

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

Placebo Placebo Comparator

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

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
No Results Posted