Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
- Conditions
- Anxiety Disorder
- Interventions
- Drug: Passiflora ; Crataegus and SalixDrug: Valeriana
- Registration Number
- NCT00794456
- Lead Sponsor
- Marjan Industria e Comercio ltda
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- generalized anxiety disorder
- HAM-A scale < 17 and > 30
- hypersensibility to any component
- patients with depression, schizophrenia ou suicidal ideas
- pregnant ou lactating
- heart, liver, lung or kidney important condition
- use of digitalis, AAS, anticoagulants agents, drugs with sedative or antidepressant action
- psychotherapy
- drug or alcohol dependence
- gastrointestinal ulcer history
- hyperthyroidism
- neoplasia
- coagulation disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Passiflora ; Crataegus and Salix Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L. 2 Valeriana Valeriana officinalis 50 mg
- Primary Outcome Measures
Name Time Method Hamilton anxiety scale 6 weeks
- Secondary Outcome Measures
Name Time Method Insomnia gravity index; global clinical impression; patients global evaluation 6 weeks
Trial Locations
- Locations (2)
Unidade de Farmacologia Clínica - UNIFAC
🇧🇷Fortaleza, Ceará, Brazil
SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo
🇧🇷Sao Paulo, Brazil
Unidade de Farmacologia Clínica - UNIFAC🇧🇷Fortaleza, Ceará, Brazil