Generalized Anxiety DisorderPhase 2NCT03463018
Echinacea Angustifolia (AnxioCalm) in Anxiety
A Phase 2 study testing Echinacea angustifolia in people with Generalized Anxiety Disorder, run by EuroPharma, Inc. at 1 site in Georgia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Echinacea angustifolia
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteGeorgia
- Study dates
- 6 Jun 2018to 15 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Generalized Anxiety Disorder
- Being tested
- Echinacea angustifolia, Placebo
- Keywords
- Echinacea, Subthreshold Anxiety
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echinacea angustifoliaDietary supplement
20 mg tablet of Echinacea angustifolia, standardized for echinacoside (not less than 3%) and alkamides (not less than 0.8%)
PlaceboDietary supplement
Placebo tablet containing matching excipients to the active intervention
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: Echinacea angustifolia |
| Placebo | Placebo comparator | Identical excipients as in the experimental arm, without the active ingredient Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2018
- Study start6 Jun 2018
- Primary completion3 Oct 2020
- Study completion15 Dec 2021
Why it stopped: Recruitment error; Inclusion criteria not met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- EuroPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Simon Khechinashvili University
- Responsible party
- Sponsor
- Investigators
- Marina Janelidze, PhD MD, Principal investigator, Simon Khechinashvili University Hospital, I.Chavchavadze 33, 0162, Tbilisi, Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03463018
- Sponsor's protocol ID
- EP-1003
- Other IDs
- EP-02-2017
- Status last verified
- Mar 2022
- First submitted
- 2 Mar 2018
- Last updated
- 24 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03463018
- Acronym / sponsor ID
- EP-1003
- Conditions
- Generalized Anxiety Disorder
- Keywords
- Echinacea, Subthreshold Anxiety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment error; Inclusion criteria not met
- Enrolment
- 100 participants (actual)
- Lead sponsor
- EuroPharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Simon Khechinashvili University
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 3 Oct 2020 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 13 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Echinacea angustifolia | Experimental | Dietary Supplement: Echinacea angustifolia20 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 | Dietary Supplement: PlaceboIdentical excipients as in the experimental arm, without the active ingredient |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echinacea angustifolia20 mg tablet of Echinacea angustifolia, standardized for echinacoside (not less than 3%) and alkamides (not less than 0.8%) | Dietary supplement | Echinacea angustifolia |
| PlaceboPlacebo tablet containing matching excipients to the active intervention | Dietary supplement | Placebo |
Primary outcome
Hamilton Anxiety Rating (HAM-A)
Time frame: 14 days
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)
Time frame: 14 days
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.
Results and safety
The study was stopped early (reason given: Recruitment error; Inclusion criteria not met). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marina Janelidze, PhD MD principal investigator
Simon Khechinashvili University Hospital, I.Chavchavadze 33, 0162, Tbilisi, Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Echinacea angustifolia in people with Generalized Anxiety Disorder, run by EuroPharma, Inc. at 1 site in Georgia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment error; Inclusion criteria not met). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating (HAM-A) (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2022.