Therapeutic Effect of an Herbal Medicine on Anxiety

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Statut

Les sponsors

Millet Roux

ESSAI CLINIQUE: NCT01178632

BioSeek: nct01178632

Mots clés

Abstrait

Phase III, double blind, randomized study, controlled by Valeriana officinalis L for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. in generalized anxiety disorder. The treatment period will last four weeks and be followed by a post treatment visit.

La description

The main objective of this study is to evaluate the clinical efficacy of the drug Passiflorine® (Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L) compared to Valeriana officinalis over a period of four weeks.

The improvement of anxiety disorders parameters (primary outcome) will be measured by the score of the Hamilton Anxiety Scale (HAM-A).

Does the administration of 2 tablets a day over a period of four weeks vs. Valeriana officinalis lead to an improvement in anxiety disorders?

Rendez-vous

Dernière vérification:	07/31/2010
Première soumission:	08/07/2010
Inscription estimée soumise:	08/08/2010
Première publication:	08/09/2010
Dernière mise à jour soumise:	08/08/2010
Dernière mise à jour publiée:	08/09/2010
Date de début réelle de l'étude:	09/30/2010
Date d'achèvement primaire estimée:	11/30/2011
Date estimée d'achèvement de l'étude:	06/30/2012

Condition ou maladie

Anxiety Disorders

Intervention / traitement

Drug: Passiflora, Anxiety Disorders

Drug: Valeriane, Anxiety Disorder

Phase

Phase 3

Groupes d'armes

Bras	Intervention / traitement
Experimental: Passiflora, Anxiety Disorders 1 tablet Passiflora;Crataegus;Salix; PO;BID	Drug: Passiflora, Anxiety Disorders 01 tablet Passiflora p.o., b.i.d.
Active Comparator: Valeriane, Anxiety Disorder 1 tablet Valeriana officinalis, PO, BID	Drug: Valeriane, Anxiety Disorder Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.

Critère d'éligibilité

Âges éligibles aux études	18 Years À 18 Years
Sexes éligibles à l'étude	All
Accepte les bénévoles en santé	Oui
Critères	Inclusion Criteria: - Clinical diagnosis of generalized anxiety disorder - HAM-A scale > 17 and <30 Exclusion Criteria: - HAM-A scale > 30 - Psychotherapy

Résultat

Mesures des résultats primaires

1. Hamilton anxiety scale score [Four weeks]

The primary outcome measure for effectiveness will be the score of the Hamilton Anxiety Scale (HAM-A). This scale will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.

Mesures des résultats secondaires

1. Insomnia gravity index [Four weeks]

The secondary outcome measure for effectiveness will be the score of the Insomnia gravity index. This questionnaire will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.

2. Clinical global impression rate scale and Patient global evaluation rate scale [Four weeks]

The other secondary outcome measure for effectiveness will be the clinical global impression rate scale and patient global evaluation rate scale. These scales will be applied in the pre-treatment (baseline), in the two visits of the treatment and in the final visit (post-treatment). Tests will be done within groups, or between different assessments and baseline values, and intergroup comparisons, i.e. between the two treatment groups at each time.

Therapeutic Effect of an Herbal Medicine on Anxiety

Mots clés

passiflorine

saule

anxiété

aubépine

crataegus rhipidophylla

salix alba

valeriana

valériane officinale

antimycosique