Therapeutic Effect of an Herbal Medicine on Anxiety

Millet Roux

Status and phase: Unknown; Phase 3

Conditions: Anxiety Disorders

Treatments: Drug: Valeriana officinalis; Drug: Passiflora

Study type: Interventional

Funder types: Industry

Identifiers

NCT01178632

MR4009

Details and patient eligibility

About

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.

Full 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?

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of generalized anxiety disorder
• HAM-A scale > 17 and <30

Exclusion criteria

• HAM-A scale > 30
• Psychotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups

Passiflora, Anxiety Disorders

Experimental group

Description:

1 tablet Passiflora;Crataegus;Salix; PO;BID

Treatment:

Drug: Passiflora

Valeriane, Anxiety Disorder

Active Comparator group

Description:

1 tablet Valeriana officinalis, PO, BID

Treatment:

Drug: Valeriana officinalis