Therapeutic Effect of an Herbal Medicine on Anxiety

Study Overview
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Brief Summary
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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
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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?

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

Conditions
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Anxiety Disorders

Intervention / Treatment
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* Drug: Passiflora
* Drug: Valeriana officinalis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of generalized anxiety disorder HAM-A scale > 17 and <30 Exclusion Criteria: HAM-A scale > 30 Psychotherapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passiflora, Anxiety Disorders<br>1 tablet Passiflora;Crataegus;Salix; PO;BID | Drug: Passiflora<br>* 01 tablet Passiflora p.o., b.i.d.<br>* Other names: PASSIFLORINE;|
| Active Comparator: Valeriane, Anxiety Disorder<br>1 tablet Valeriana officinalis, PO, BID | Drug: Valeriana officinalis<br>* Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.<br>* Other names: VALERIANE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton anxiety scale score | 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. | Four weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia gravity index | 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. | Four weeks | 
| Clinical global impression rate scale and Patient global evaluation rate scale | 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. | Four weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Herbal, Phytotherapy, Passiflora, Valeriana, Anxiety