Trials / Terminated
TerminatedNCT03463018
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
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- Sponsor
- EuroPharma, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-06-06
- Primary completion
- 2020-10-03
- Completion
- 2021-12-15
- First posted
- 2018-03-13
- Last updated
- 2022-03-24
Locations
1 site across 1 country: Georgia
Source: ClinicalTrials.gov record NCT03463018. Inclusion in this directory is not an endorsement.