Therapeutic Effect of an Herbal Medicine on Anxiety

NCT01178632 — Phase 3, Unknown, 136 participants, Millet Roux

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A Double-blind, Randomized, Controlled, Phase III Study of an Herbal Medicine Association for Generalized Anxiety Disorder

Registry	NCT01178632
Status	Unknown
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	136 (Estimated)
Sponsor	Millet Roux (Industry)
Conditions	Anxiety Disorders
Interventions	Passiflora, Valeriana officinalis (Drug)
Dates	start 2010-10-01, primary completion 2011-12-01 (estimated), completion 2012-07-01 (estimated), first posted 2010-08-10, last updated 2010-08-10
Locations	1 site in Brazil

-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.

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+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?

+Arms and interventions

Arm	Type	Interventions	Description
Passiflora, Anxiety Disorders	Experimental	Drug: Passiflora	1 tablet Passiflora;Crataegus;Salix; PO;BID
Valeriane, Anxiety Disorder	Active comparator	Drug: Valeriana officinalis	1 tablet Valeriana officinalis, PO, BID

Passiflora (Drug), also known as PASSIFLORINE: 01 tablet Passiflora p.o., b.i.d.
Valeriana officinalis (Drug), also known as VALERIANE: Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.

+Outcome measures

Primary outcomes

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 outcomes

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.

+Eligibility

Sex: All, ages: 18 Years to 65 Years

Inclusion Criteria:

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

Exclusion Criteria:

* HAM-A scale > 30
* Psychotherapy

+Locations (1)

Facility	City	Country	Status
Clinical Pharmacology Unit - Unifac	Fortaleza, Ceará	Brazil

+Investigators

MARIA ELISABETE A MORAES, MD, PhD, Study director, CLINICAL PHARMACOLOGY UNIT - UNIFAC