Therapeutic Effect of an Herbal Medicine on Anxiety

Solo los usuarios registrados pueden traducir artículos

Iniciar sesión Registrarse

El enlace se guarda en el portapapeles.

Estado

Patrocinadores

Millet Roux

ENSAYO CLÍNICO: NCT01178632

BioSeek: nct01178632

Palabras clave

Abstracto

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.

Descripción

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?

fechas

Verificado por última vez:	07/31/2010
Primero enviado:	08/07/2010
Inscripción estimada enviada:	08/08/2010
Publicado por primera vez:	08/09/2010
Última actualización enviada:	08/08/2010
Última actualización publicada:	08/09/2010
Fecha de inicio real del estudio:	09/30/2010
Fecha estimada de finalización primaria:	11/30/2011
Fecha estimada de finalización del estudio:	06/30/2012

Condición o enfermedad

Anxiety Disorders

Intervención / tratamiento

Drug: Passiflora, Anxiety Disorders

Drug: Valeriane, Anxiety Disorder

Fase

Fase 3

Grupos de brazos

Brazo	Intervención / tratamiento
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.

Criterio de elegibilidad

Edades elegibles para estudiar	18 Years A 18 Years
Sexos elegibles para estudiar	All
Acepta voluntarios saludables	si
Criterios	Inclusion Criteria: - Clinical diagnosis of generalized anxiety disorder - HAM-A scale > 17 and <30 Exclusion Criteria: - HAM-A scale > 30 - Psychotherapy

Salir

Medidas de resultado primarias

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.

Medidas de resultado secundarias

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

Palabras clave

passiflorine

salix

ansiedad

crataegus

crataegus rhipidophylla

salix alba

valeriana

valeriana officinalis

antifúngico