Therapeutic Effect of an Herbal Medicine on Anxiety

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Sponsorii

Millet Roux

STUDIU CLINIC: NCT01178632

BioSeek: nct01178632

Cuvinte cheie

Abstract

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.

Descriere

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?

Datele

Ultima verificare:	07/31/2010
Primul depus:	08/07/2010
Inscriere estimată trimisă:	08/08/2010
Prima postare:	08/09/2010
Ultima actualizare trimisă:	08/08/2010
Ultima actualizare postată:	08/09/2010
Data actuală de începere a studiului:	09/30/2010
Data estimată de finalizare primară:	11/30/2011
Data estimată de finalizare a studiului:	06/30/2012

Stare sau boală

Anxiety Disorders

Intervenție / tratament

Drug: Passiflora, Anxiety Disorders

Drug: Valeriane, Anxiety Disorder

Fază

Fază 3

Grupuri de brațe

Braţ	Intervenție / tratament
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.

Criterii de eligibilitate

Vârste eligibile pentru studiu	18 Years La 18 Years
Sexe eligibile pentru studiu	All
Acceptă voluntari sănătoși	da
Criterii	Inclusion Criteria: - Clinical diagnosis of generalized anxiety disorder - HAM-A scale > 17 and <30 Exclusion Criteria: - HAM-A scale > 30 - Psychotherapy

Rezultat

Măsuri de rezultate primare

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.

Măsuri de rezultate secundare

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

Cuvinte cheie

passiflorine

salcie

anxietate

crataegus

crataegus rhipidophylla

salix alba

valeriana

valeriană

antifungic