Gelsemium Sempervirens in Anticipatory Anxiety

Anxiety Clinical Trial

— ANXIHOMEV  

Official title:

Randomized Controlled Study Versus Placebo Evaluating Effectiveness of Gelsemium Sempervirens (5CH et 15CH) on Provoked Anticipatory Anxiety, in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00914329
• Other study ID #: DCIC 08 20
• Status: Completed
• Phase: Phase 3
• First received: May 29, 2009
• Last updated: June 2, 2010
• Start date: June 2009
• Est. completion date: May 2010

Study information

• Verified date: June 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders

Intervention

Drug:
• Gelsemium Sempervirens
5CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
• Gelsemium Sempervirens
15CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
• Placebo
placebo, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.

Locations

Country	Name	City	State
France	Clinical Research Center	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	BOIRON

Country where clinical trial is conducted

France, 

References & Publications (2)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	anxiety measured by STAI-T		day -7 and day -5	No
Secondary	score of stress-test		day 0	No