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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
150
1 tablet PO twice a day
1 tablet PO twice a day
Unidade de Farmacologia Clínica - UNIFAC
Fortaleza, Ceará, Brazil
SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo
São Paulo, São Paulo, Brazil
Hamilton anxiety scale
Time frame: 6 weeks
Insomnia gravity index; global clinical impression; patients global evaluation
Time frame: 6 weeks
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