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Gelsemium Sempervirens in Anticipatory Anxiety

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala
Ingia / Ingia
Kiungo kimehifadhiwa kwenye clipboard
HaliImekamilika
Wadhamini
University Hospital, Grenoble
Washirika
BOIRON

Maneno muhimu

Kikemikali

To evaluate the effectiveness of Gelsemium sempervirens 5CH et 15CH on anticipatory provoked anxiety, in healthy volunteers.

Maelezo

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.

Tarehe

Imethibitishwa Mwisho: 05/31/2010
Iliyowasilishwa Kwanza: 05/28/2009
Uandikishaji uliokadiriwa Uliwasilishwa: 06/03/2009
Iliyotumwa Kwanza: 06/04/2009
Sasisho la Mwisho Liliwasilishwa: 06/01/2010
Sasisho la Mwisho Lilichapishwa: 06/02/2010
Tarehe halisi ya kuanza kwa masomo: 05/31/2009
Tarehe ya Kukamilisha Msingi iliyokadiriwa: 03/31/2010
Tarehe ya Kukamilisha Utafiti: 04/30/2010

Hali au ugonjwa

Anxiety

Uingiliaji / matibabu

Drug: Gelsemium 5CH

Drug: Gelsemium 15CH

Drug: Placebo

Awamu

Awamu 3

Vikundi vya Arm

MkonoUingiliaji / matibabu
Experimental: Gelsemium 5CH
Globules of Gelsemium sempervirens 5CH
Drug: Gelsemium 5CH
5CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
Experimental: Gelsemium 15CH
Globules of Gelsemium Sempervirens 15CH
Drug: Gelsemium 15CH
15CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
Placebo Comparator: Placebo
Globules of placebo
Drug: Placebo
placebo, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza 18 Years Kwa 18 Years
Jinsia Inastahiki KujifunzaAll
Hupokea Wajitolea wa AfyaNdio
Vigezo

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

Matokeo

Hatua za Matokeo ya Msingi

1. 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]

Hatua za Matokeo ya Sekondari

1. 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]

2. 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) [day 0]

3. 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]

4. anxiety measured by STAI-T [day -7 and day -5]

5. score of stress-test [day 0]

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