Echinacea Angustifolia (AnxioCalm) in Anxiety

NCT03463018 | Terminated Phase 2

• 2 other identifiers: EP-1003EP-02-2017
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Keywords

Echinacea, Subthreshold Anxiety

Outcome Measures

Primary Outcomes (2)

• Hamilton Anxiety Rating (HAM-A)

  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.

  14 days

• State-Trait Anxiety Inventory (STAI)

  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.

  14 days

Study Arms (2)

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

Dietary Supplement: Echinacea angustifolia

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Echinacea angustifolia DIETARY_SUPPLEMENT

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

Echinacea angustifolia

Placebo DIETARY_SUPPLEMENT

Placebo tablet containing matching excipients to the active intervention

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• EuroPharma, Inc.: lead
• Simon Khechinashvili University: collaborator

Study Sites (1)

Simon Skechinashvili University Hospital

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Echinacea extract

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Marina Janelidze, PhD MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: March 13, 2018
• Study Start: June 6, 2018
• Primary Completion: October 3, 2020
• Study Completion: December 15, 2021
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)