Gelsemium Sempervirens in Anticipatory Anxiety (ANXIHOMEV)
Primary Purpose
Anxiety
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Gelsemium Sempervirens
Gelsemium Sempervirens
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety focused on measuring stress provoked, healthy volunteers, gelsemium, homeopathy
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
Sites / Locations
- Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Gelsemium 5CH
Gelsemium 15CH
Placebo
Arm Description
Globules of Gelsemium sempervirens 5CH
Globules of Gelsemium Sempervirens 15CH
Globules of placebo
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
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)
Continue measure of arterial pressure, heart rate, respiratory rate, according to the treatment received by the volunteers (Gelsemium sempervirens 5CH, 15CH or placebo)
anxiety measured by STAI-T
score of stress-test
Full Information
NCT ID
NCT00914329
First Posted
May 29, 2009
Last Updated
June 2, 2010
Sponsor
University Hospital, Grenoble
Collaborators
BOIRON
1. Study Identification
Unique Protocol Identification Number
NCT00914329
Brief Title
Gelsemium Sempervirens in Anticipatory Anxiety
Acronym
ANXIHOMEV
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
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Grenoble
Collaborators
BOIRON
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety
Keywords
stress provoked, healthy volunteers, gelsemium, homeopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Gelsemium 5CH
Arm Type
Experimental
Arm Description
Globules of Gelsemium sempervirens 5CH
Arm Title
Gelsemium 15CH
Arm Type
Experimental
Arm Description
Globules of Gelsemium Sempervirens 15CH
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Globules of placebo
Intervention Type
Drug
Intervention Name(s)
Gelsemium Sempervirens
Intervention Description
5CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
Intervention Type
Drug
Intervention Name(s)
Gelsemium Sempervirens
Intervention Description
15CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
Title
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
Title
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
Title
anxiety measured by STAI-T
Time Frame
day -7 and day -5
Title
score of stress-test
Time Frame
day 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Luc CRACOWSKI, MD, PhD
Organizational Affiliation
CIC, CHU Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinical Research Center
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Citations:
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.
Results Reference
background
Citation
Nasolotsiry E. Raveloson ; R. Rasoloherimampiononiaina ; A. Ramialiharisoa. Indication homéopathique en prémédication anesthésique. Correspondance homéoweb.
Results Reference
background
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Gelsemium Sempervirens in Anticipatory Anxiety
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