AnxietyPhase 3ANXIHOMEVNCT00914329
Gelsemium Sempervirens in Anticipatory Anxiety
A Phase 3 study testing Gelsemium Sempervirens in people with Anxiety, run by University Hospital, Grenoble at 1 site in France.
Trial summary
To evaluate the effectiveness of Gelsemium sempervirens 5CH et 15CH on anticipatory provoked anxiety, in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Gelsemium Sempervirens
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2009to May 2010
- Phase
- Phase 3
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Man or woman,
- age between 18 et 40 ans,
- affiliated to a regime of social security or equivalent
Who cannot join
- Medical history of psychiatric disease relevant of psychoses,
- Medical history of hospitalisation in psychiatric environment,
- psychotropic substance of the class of antidepressants, antipsychotics and normothymics), in the year before inclusion,
- Taking, even punctual of psychotropics substances of the class of benzodiazepines and related, in the month before inclusion,
- Taking, even punctual of psychotropics substances of the class of anxiolytics non benzodiazepines, in the month before inclusion: meprobamate, hydroxyzine, buspirone, captodiamine, pregabalin, etifoxine,
- Taking, even punctual of substances of the class of the sedatives divers, in the month before inclusion: phytotherapy, homeopathy, sedatives with brome, mineral elements,
Show all 13Show fewer
- Taking, even punctual of substances of the class of antihistamine with hypnotic aim, in the month before inclusion,
- Taking, even punctual of propanolol in the month before inclusion
- Known Addiction,
- Handicap incompatible with the Stress Test : blindness, partially sighted, daltonism, dementia, language troubles,
- Pregnancy, parturient and nursing woman,
- Person private of freedom by judicial or administrative decision, person under measure of legal protection,
- allergy to one of the constituents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Study Versus Placebo Evaluating Effectiveness of Gelsemium Sempervirens (5CH et 15CH) on Provoked Anticipatory Anxiety, in Healthy Volunteers
To evaluate the effectiveness of Gelsemium sempervirens 5CH et 15CH on anticipatory provoked anxiety, in healthy volunteers.
Read the detailed description
State-anxiety can appear during banal events without objective harrowing factors. It is preponderant in particular situations as exams and competitive examination for example, and may be responsible of failures, notably at school. Particularly, a form of anxiety said anticipatory (largely named nerves) is focused on a coming performance. This anticipative anxiety, maximal before the beginning of the test, disappears during this test to let place to relief. Even if phenomenon of habituation exists, it can be responsible of social and professional failures.
Numerous therapeutics exists to fight against anxiety, non medicinal first but the resort to drugs are sometime necessary. The reference is the class of benzodiazepines. Many patients try non conventional medicines, like homeopathy.
Gelsemium sempervirens would be active on sensible et emotional persons, reducing anxiety in some situations. A large used of Gelsemium sempervirens is the case of a situation of provoked stress in particular exam. That is the reason why the drug is particularly intended to a population of young adults who don't want to use " traditional " tranquillizing. But this drug, largely used, has never showed his effectiveness on provoked anxiety, in biomedical research. That is why we proposed in this study to compare the effectiveness of Gelsemium sempervirens 5CH, Gelsemium sempervirens 15CH and placebo, in a situation of provoked anxiety in young adult healthy volunteers.
- Conditions
- Anxiety
- Being tested
- Gelsemium Sempervirens, Placebo
- Keywords
- stress provoked, healthy volunteers, gelsemium, homeopathy
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelsemium SempervirensDrug
5CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
Gelsemium SempervirensDrug
15CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
PlaceboDrug
placebo, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
| Study group | Role | What they receive |
|---|---|---|
| Gelsemium 5CH | Experimental | Globules of Gelsemium sempervirens 5CH Receives: Drug: Gelsemium Sempervirens |
| Gelsemium 15CH | Experimental | Globules of Gelsemium Sempervirens 15CH Receives: Drug: Gelsemium Sempervirens |
| Placebo | Placebo comparator | Globules of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level evaluated by the STAI-E, in absolute value and et difference with basal state, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo)
Measured: day 0
Secondary outcomes (5)
anxiety level measured by the visual analogic scale of anxiety, in absolute value and difference with the basal state, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo)
Measured: day -7, day -5 and day 0
anxiety level measured by the scale of anxiety state in competition (EEAC), in absolute value and difference with the basal state, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo)
Measured: day 0
Continue measure of arterial pressure, heart rate, respiratory rate, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo)
Measured: day 0
anxiety measured by STAI-T
Measured: day -7 and day -5
score of stress-test
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- BOIRON
- Investigators
- Jean-Luc CRACOWSKI, MD, PhD, Principal investigator, CIC, CHU Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00914329
- Sponsor's protocol ID
- DCIC 08 20
- Acronym
- ANXIHOMEV
- Status last verified
- Jun 2010
- First submitted
- 29 May 2009
- Last updated
- 3 Jun 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Binsard AM, Guillemain J, Platel A, Savini EC, Tetau M. Etude psychopharmacologique de dilution homéopathiques de Gelsemium et d'Ignatia. Ann Homeop Fr. 22: 35-50; 1980.
Nasolotsiry E. Raveloson ; R. Rasoloherimampiononiaina ; A. Ramialiharisoa. Indication homéopathique en prémédication anesthésique. Correspondance homéoweb.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Versus Placebo Evaluating Effectiveness of Gelsemium Sempervirens (5CH et 15CH) on Provoked Anticipatory Anxiety, in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT00914329
- Acronym / sponsor ID
- ANXIHOMEV / DCIC 08 20
- Conditions
- Anxiety
- Keywords
- stress provoked, healthy volunteers, gelsemium, homeopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- BOIRON
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 5 Jun 2009 (estimated)
- 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.
To evaluate the effectiveness of Gelsemium sempervirens 5CH et 15CH on anticipatory provoked anxiety, in healthy volunteers.
Detailed description
State-anxiety can appear during banal events without objective harrowing factors. It is preponderant in particular situations as exams and competitive examination for example, and may be responsible of failures, notably at school. Particularly, a form of anxiety said anticipatory (largely named nerves) is focused on a coming performance. This anticipative anxiety, maximal before the beginning of the test, disappears during this test to let place to relief. Even if phenomenon of habituation exists, it can be responsible of social and professional failures.
Numerous therapeutics exists to fight against anxiety, non medicinal first but the resort to drugs are sometime necessary. The reference is the class of benzodiazepines. Many patients try non conventional medicines, like homeopathy.
Gelsemium sempervirens would be active on sensible et emotional persons, reducing anxiety in some situations. A large used of Gelsemium sempervirens is the case of a situation of provoked stress in particular exam. That is the reason why the drug is particularly intended to a population of young adults who don't want to use " traditional " tranquillizing. But this drug, largely used, has never showed his effectiveness on provoked anxiety, in biomedical research. That is why we proposed in this study to compare the effectiveness of Gelsemium sempervirens 5CH, Gelsemium sempervirens 15CH and placebo, in a situation of provoked anxiety in young adult healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Gelsemium 5CH | Experimental | Drug: Gelsemium SempervirensGlobules of Gelsemium sempervirens 5CH |
| Gelsemium 15CH | Experimental | Drug: Gelsemium SempervirensGlobules of Gelsemium Sempervirens 15CH |
| Placebo | Placebo comparator | Drug: PlaceboGlobules of placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Man or woman,
- age between 18 et 40 ans,
- affiliated to a regime of social security or equivalent
Key exclusion criteria (13 listed)
- Medical history of psychiatric disease relevant of psychoses,
- Medical history of hospitalisation in psychiatric environment,
- psychotropic substance of the class of antidepressants, antipsychotics and normothymics), in the year before inclusion,
- Taking, even punctual of psychotropics substances of the class of benzodiazepines and related, in the month before inclusion,
- Taking, even punctual of psychotropics substances of the class of anxiolytics non benzodiazepines, in the month before inclusion: meprobamate, hydroxyzine, buspirone, captodiamine, pregabalin, etifoxine,
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 |
|---|---|---|
| Gelsemium Sempervirens5CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test. | Drug | Gelsemium 5CH |
| Gelsemium Sempervirens15CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test. | Drug | Gelsemium 15CH |
| Placeboplacebo, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test. | Drug | Placebo |
Primary outcome
Anxiety level evaluated by the STAI-E, in absolute value and et difference with basal state, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo)
Time frame: day 0
5 secondary outcomes
anxiety level measured by the visual analogic scale of anxiety, in absolute value and difference with the basal state, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo)
Time frame: day -7, day -5 and day 0
anxiety level measured by the scale of anxiety state in competition (EEAC), in absolute value and difference with the basal state, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo)
Time frame: day 0
Continue measure of arterial pressure, heart rate, respiratory rate, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo)
Time frame: day 0
anxiety measured by STAI-T
Time frame: day -7 and day -5
score of stress-test
Time frame: day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2010.
- BackgroundBinsard AM, Guillemain J, Platel A, Savini EC, Tetau M. Etude psychopharmacologique de dilution homéopathiques de Gelsemium et d'Ignatia. Ann Homeop Fr. 22: 35-50; 1980.
- BackgroundNasolotsiry E. Raveloson ; R. Rasoloherimampiononiaina ; A. Ramialiharisoa. Indication homéopathique en prémédication anesthésique. Correspondance homéoweb.
Related trials for Anxiety
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruitingObservational study
Soap-and-Water Bed Bath Versus Disposable Wipe Bath in the Same ICU Patients
Critical Illness, Pain
Recruiting
Peer-Mentor Support for Vulnerable Patients With Atrial Fibrillation
Atrial Fibrillation
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Not yet recruiting
Feasibility of a Web-based Single-session Intervention Combined With Ecological Momentary Assessment and Intervention for Patients With Complex Posttraumatic Stress Disorder Awaiting Inpatient Treatment
PTSD - Post Traumatic Stress Disorder, Depression
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.
Jean-Luc CRACOWSKI, MD, PhD principal investigator
CIC, CHU Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gelsemium Sempervirens in people with Anxiety, run by University Hospital, Grenoble at 1 site in France.
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 3 inclusion and 13 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: finished, as of the sponsor's last update on 3 Jun 2010. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Anxiety level evaluated by the STAI-E, in absolute value and et difference with basal state, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo) (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00914329, which also lists 2 linked publications.
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 3 Jun 2010.