Gelsemium Sempervirens in Anticipatory Anxiety

NCT00914329 | Completed Phase 3

• 1 other identifier: DCIC 08 20
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety

Keywords

stress provoked; healthy volunteers; gelsemium; homeopathy

Outcome Measures

Primary Outcomes (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

Secondary Outcomes (5)

• 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

• 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

• 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

• anxiety measured by STAI-T

  day -7 and day -5

• score of stress-test

  day 0

Study Arms (3)

Gelsemium 5CH

EXPERIMENTAL

Globules of Gelsemium sempervirens 5CH

Drug: Gelsemium Sempervirens

Gelsemium 15CH

EXPERIMENTAL

Globules of Gelsemium Sempervirens 15CH

Drug: Gelsemium Sempervirens

Placebo

PLACEBO COMPARATOR

Globules of placebo

Drug: Placebo

Interventions

Gelsemium Sempervirens DRUG

5CH, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.

Gelsemium 5CH

Placebo DRUG

placebo, one dose of globules morning and evening during 2 days plus one dose the morning of the day of the stress-test.

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Man or woman,
• age between 18 et 40 ans,
• affiliated to a regime of social security or equivalent

You may not qualify if:

• Medical history of psychiatric disease relevant of psychoses,
• Medical history of hospitalisation in psychiatric environment,
• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• BOIRON: collaborator

Study Sites (1)

Clinical Research Center

Grenoble, 38043, France

Location

Related 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.

  BACKGROUND

• Nasolotsiry E. Raveloson ; R. Rasoloherimampiononiaina ; A. Ramialiharisoa. Indication homéopathique en prémédication anesthésique. Correspondance homéoweb.

  BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Jean-Luc CRACOWSKI, MD, PhD

  CIC, CHU Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 29, 2009
• First Posted: June 5, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 3, 2010

Record last verified: 2010-06

Locations

FR (1)