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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.
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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passiflora, Anxiety Disorders | Experimental | 1 tablet Passiflora;Crataegus;Salix; PO;BID |
|
| Valeriane, Anxiety Disorder | Active Comparator | 1 tablet Valeriana officinalis, PO, BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passiflora | Drug | 01 tablet Passiflora p.o., b.i.d. |
|
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MARIA ELISABETE A MORAES, MD, PhD | Contact | 5585-32232903 | betemora@matrix.com.br |
| Name | Affiliation | Role |
|---|---|---|
| MARIA ELISABETE A MORAES, MD, PhD | CLINICAL PHARMACOLOGY UNIT - UNIFAC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit - Unifac | Fortaleza | Ceará | 60430-270 | Brazil |
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| Label | URL |
|---|---|
| ANXIETY DISORDERS | View source |
| Passion Flower | View source |
| Valeriana officinalis |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000713890 | Valeriana extract |
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| Valeriana officinalis | Drug | Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d. |
|
|
| 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 |