Gelsemium Sempervirens in Anticipatory Anxiety - Full Text View

Sponsors and Collaborators:	University Hospital, Grenoble BOIRON
Information provided by:	University Hospital, Grenoble
ClinicalTrials.gov Identifier:	NCT00914329

Purpose

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

Condition	Intervention	Phase
Anxiety	Drug: Gelsemium Sempervirens Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Study Versus Placebo Evaluating Effectiveness of Gelsemium Sempervirens (5CH et 15CH) on Provoked Anticipatory Anxiety, in Healthy Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

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) [ Time Frame: day 0 ] [ Designated as safety issue: No ]

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) [ 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 ]

Estimated Enrollment:	180
Study Start Date:	June 2009
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Gelsemium 5CH: Experimental Globules of Gelsemium sempervirens 5CH	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 15CH: Experimental Globules of Gelsemium Sempervirens 15CH	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.
Placebo: Placebo Comparator 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.

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

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00914329

Contacts

Contact: Jean-Luc CRACOWSKI, MD, PhD	0033476769260	jlcracowski@chu-grenoble.fr
Contact: Adeline PARIS, PharmD, PhD	003476767383	AParis@chu-grenoble.fr

Locations

France
Clinical Research Center
Grenoble, France, 38043

Sponsors and Collaborators

University Hospital, Grenoble

BOIRON

Investigators

Principal Investigator:

Jean-Luc CRACOWSKI, MD, PhD

CIC, CHU Grenoble

More Information

No publications provided

Responsible Party:	CHU de Grenoble ( Mr FrédérickMarie )
Study ID Numbers:	DCIC 08 20
Study First Received:	May 29, 2009
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00914329 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:

stress provoked
healthy volunteers
gelsemium
homeopathy

Study placed in the following topic categories:

Stress
Healthy

ClinicalTrials.gov processed this record on September 03, 2009