Therapeutic Effect of an Herbal Medicine on Anxiety

Phase 3

• Conditions: Anxiety Disorders
• Interventions: Drug: Passiflora; Drug: Valeriana officinalis

• Registration Number: NCT01178632
• Lead Sponsor: Millet Roux

Brief Summary

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.

Detailed 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?

Study Timeline

• Status Verified: 2010-08
• Study First Submitted: 2010-08-08
• Study First Submitted QC: 2010-08-09
• Last Update Submitted: 2010-08-09
• Study First Posted: 2010-08-10
• Last Update Posted: 2010-08-10
• Study Start: 2010-10
• Primary Completion: 2011-12
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

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

Exclusion Criteria

• HAM-A scale > 30
• Psychotherapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Passiflora, Anxiety Disorders	Passiflora	1 tablet Passiflora;Crataegus;Salix; PO;BID
Valeriane, Anxiety Disorder	Valeriana officinalis	1 tablet Valeriana officinalis, PO, BID

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Clinical Pharmacology Unit - Unifac; 🇧🇷 Fortaleza, Ceara, Brazil