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Phase III, multicentric, double blind, randomized study, controlled by Valeriana officinalis for evaluating the efficacy of association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. on mild and moderate anxiety. The treatment period will last 6 weeks and be followed by a post treatment visit.
Hamilton anxiety scale will be used to assess anxiety.
Passiflora incarnata L; Crataegus Oxyacantha L are plant-derived treatment widely used to treat anxiety disorders. This study will compare the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L for the treatment of mild and moderate anxiety. 150 participants will be randomly assigned to receive the association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. or Valeriana officinalis for 6 weeks. A post treatment visit will be done 2 weeks for safety evaluation.
Primary outcome: Hamilton anxiety (HAM-A) scale Secondary outcome: Insomnia quality index, Global clinical impression and patients global evaluation scales.
Side effects will be monitorized throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. |
|
| 2 | Active Comparator | Valeriana officinalis 50 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Passiflora ; Crataegus and Salix | Drug | 1 tablet PO twice a day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton anxiety scale | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia gravity index; global clinical impression; patients global evaluation | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria Elisabete A Moraes, MD | Federal University of Ceará | Principal Investigator |
| Antonio C Lopes, Phd | Federal University of Sao Paulo - UNIFESP / DPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade de Farmacologia Clínica - UNIFAC | Fortaleza | Ceará | 60430-270 | Brazil | ||
| SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C007145 | crataegus extract |
| C000713809 | willow bark extract |
| C000713890 | Valeriana extract |
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| Valeriana | Drug | 1 tablet PO twice a day |
|
|
| São Paulo |
| São Paulo |
| 04024-002 |
| Brazil |