Therapeutic Effect of an Herbal Medicine on Anxiety

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Estat

Patrocinadors

Millet Roux

ASSAIG CLÍNIC: NCT01178632

BioSeek: nct01178632

Paraules clau

Resum

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.

Descripció

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?

Dates

Darrera verificació:	07/31/2010
Primer enviat:	08/07/2010
Inscripció estimada enviada:	08/08/2010
Publicat per primera vegada:	08/09/2010
Última actualització enviada:	08/08/2010
Publicació de l'última actualització:	08/09/2010
Data d'inici de l'estudi real:	09/30/2010
Data estimada de finalització primària:	11/30/2011
Data estimada de finalització de l’estudi:	06/30/2012

Condició o malaltia

Anxiety Disorders

Intervenció / tractament

Drug: Passiflora, Anxiety Disorders

Drug: Valeriane, Anxiety Disorder

Fase

Fase 3

Grups de braços

Braç	Intervenció / tractament
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.

Criteris d'elegibilitat

Edats elegibles per estudiar	18 Years Per a 18 Years
Sexes elegibles per estudiar	All
Accepta voluntaris saludables	Sí
Criteris	Inclusion Criteria: - Clinical diagnosis of generalized anxiety disorder - HAM-A scale > 17 and <30 Exclusion Criteria: - HAM-A scale > 30 - Psychotherapy

Resultat

Mesures de resultats primaris

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 de resultats secundaris

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

Paraules clau

passiflorine

salze

ansietat

crataegus

crataegus rhipidophylla

salze blanc

valeriana

valeriana vera

antifúngic