Clinical trial NCT00914329: Gelsemium Sempervirens in Anticipatory Anxiety
Official title: Randomized Controlled Study Versus Placebo Evaluating Effectiveness of Gelsemium Sempervirens (5CH et 15CH) on Provoked Anticipatory Anxiety, in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety
Keywords: stress provoked
healthy volunteers
gelsemium
homeopathy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: BOIRON
First posted: 2009-06-05
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Man or woman,
* age between 18 et 40 ans,
* affiliated to a regime of social security or equivalent

Exclusion Criteria:

* 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,
* 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

Primary outcomes:
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)
timeFrame: day 0
Secondary outcomes:
measure: 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)
timeFrame: day -7, day -5 and day 0
measure: 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)
timeFrame: day 0
measure: Continue measure of arterial pressure, heart rate, respiratory rate, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo)
timeFrame: day 0
measure: anxiety measured by STAI-T
timeFrame: day -7 and day -5
measure: score of stress-test
timeFrame: day 0
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinical Research Center
Study officials:
affiliation: CIC, CHU Grenoble
name: Jean-Luc CRACOWSKI, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Nasolotsiry E. Raveloson ; R. Rasoloherimampiononiaina ; A. Ramialiharisoa. Indication homéopathique en prémédication anesthésique. Correspondance homéoweb.