Therapeutic Effect of an Herbal Medicine on Anxiety

Status:

Unknown status

Sponsors

Millet Roux

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.

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?

Last Verified:	July/31/2010
First Submitted:	August/7/2010
Estimated Enrollment Submitted:	August/8/2010
First Posted:	August/9/2010
Last Update Submitted:	August/8/2010
Last Update Posted:	August/9/2010
Actual Study Start Date:	September/30/2010
Estimated Primary Completion Date:	November/30/2011
Estimated Study Completion Date:	June/30/2012

Condition or disease:Anxiety Disorders

Intervention/treatment:

Drug: Passiflora, Anxiety Disorders

Drug: Valeriane, Anxiety Disorder

Phase:Phase 3

Study design:

Study Type:	Interventional
Allocation:	Randomized
Primary Purpose:	Treatment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm group:

Arm	Intervention/treatment
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.

Eligibility Criteria:

Ages Eligible for Study:	18 Years to 18 Years
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Criteria:	Inclusion Criteria: - Clinical diagnosis of generalized anxiety disorder - HAM-A scale > 17 and <30 Exclusion Criteria: - HAM-A scale > 30 - Psychotherapy

Outcome:

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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Clinical Trial

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