Gelsemium Sempervirens in Anticipatory Anxiety (ANXIHOMEV)

This study has been completed.
Sponsor:
Collaborator:
BOIRON
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00914329
First received: May 29, 2009
Last updated: June 2, 2010
Last verified: June 2010

May 29, 2009
June 2, 2010
June 2009
April 2010   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00914329 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • anxiety measured by STAI-T [ Time Frame: day -7 and day -5 ] [ Designated as safety issue: No ]
  • score of stress-test [ Time Frame: day 0 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Gelsemium Sempervirens in Anticipatory Anxiety
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Anxiety
  • 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.
  • Drug: 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.
  • 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.
  • Experimental: Gelsemium 5CH
    Globules of Gelsemium sempervirens 5CH
    Intervention: Drug: Gelsemium Sempervirens
  • Experimental: Gelsemium 15CH
    Globules of Gelsemium Sempervirens 15CH
    Intervention: Drug: Gelsemium Sempervirens
  • Placebo Comparator: Placebo
    Globules of placebo
    Intervention: Drug: Placebo
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
May 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00914329
DCIC 08 20
No
Mr FrédérickMarie, CHU de Grenoble
University Hospital, Grenoble
BOIRON
Principal Investigator: Jean-Luc CRACOWSKI, MD, PhD CIC, CHU Grenoble
University Hospital, Grenoble
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP