Echinacea Angustifolia (AnxioCalm) in Anxiety | NCT03463018

NCT03463018

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
EP-02-2017	Other Identifier	Sponsor

Status Module

Name	Class
Simon Khechinashvili University	UNKNOWN

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

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

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders