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| Name | Class |
|---|---|
| BOIRON | INDUSTRY |
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To evaluate the effectiveness of Gelsemium sempervirens 5CH et 15CH on anticipatory provoked anxiety, in healthy volunteers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gelsemium 5CH | Experimental | Globules of Gelsemium sempervirens 5CH |
|
| Gelsemium 15CH | Experimental | Globules of Gelsemium Sempervirens 15CH |
|
| Placebo | Placebo Comparator | Globules of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gelsemium Sempervirens | Drug | 5CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Luc CRACOWSKI, MD, PhD | CIC, CHU Grenoble | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center | Grenoble | 38043 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| Background | Nasolotsiry E. Raveloson ; R. Rasoloherimampiononiaina ; A. Ramialiharisoa. Indication homéopathique en prémédication anesthésique. Correspondance homéoweb. |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Gelsemium Sempervirens | Drug | 15CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test. |
|
| Placebo | Drug | placebo, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test. |
|
| 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) | day 0 |
| anxiety measured by STAI-T | day -7 and day -5 |
| score of stress-test | day 0 |