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Echinacea Angustifolia (AnxioCalm) in Anxiety

Primary Purpose

Generalized Anxiety Disorder

Status
Terminated
Phase
Phase 2
Locations
Georgia
Study Type
Interventional
Intervention
Echinacea angustifolia
Placebo
Sponsored by
EuroPharma, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring Echinacea, Subthreshold Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Simon Skechinashvili University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Echinacea angustifolia

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
March 2, 2018
Last Updated
March 22, 2022
Sponsor
EuroPharma, Inc.
Collaborators
Simon Khechinashvili University
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1. Study Identification

Unique Protocol Identification Number
NCT03463018
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment error; Inclusion criteria not met
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
October 3, 2020 (Actual)
Study Completion Date
December 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EuroPharma, Inc.
Collaborators
Simon Khechinashvili University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
Echinacea, Subthreshold Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Echinacea angustifolia
Arm Type
Experimental
Arm Description
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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical excipients as in the experimental arm, without the active ingredient
Intervention Type
Dietary Supplement
Intervention Name(s)
Echinacea angustifolia
Intervention Description
20 mg tablet of Echinacea angustifolia, standardized for echinacoside (not less than 3%) and alkamides (not less than 0.8%)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet containing matching excipients to the active intervention
Primary Outcome Measure Information:
Title
Hamilton Anxiety Rating (HAM-A)
Description
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.
Time Frame
14 days
Title
State-Trait Anxiety Inventory (STAI)
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marina Janelidze, PhD MD
Organizational Affiliation
Simon Khechinashvili University Hospital, I.Chavchavadze 33, 0162, Tbilisi, Georgia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simon Skechinashvili University Hospital
City
Tbilisi
Country
Georgia

12. IPD Sharing Statement

Plan to Share IPD
No

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Echinacea Angustifolia (AnxioCalm) in Anxiety

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