Status:
COMPLETED
Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
Lead Sponsor:
Marjan Industria e Comercio ltda
Conditions:
Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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...
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 Oxyacant...
Eligibility Criteria
Inclusion
- generalized anxiety disorder
- HAM-A scale \< 17 and \> 30
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00794456
Start Date
September 1 2009
End Date
October 1 2013
Last Update
July 8 2014
Active Locations (2)
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1
Unidade de Farmacologia Clínica - UNIFAC
Fortaleza, Ceará, Brazil, 60430-270
2
SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo
São Paulo, São Paulo, Brazil, 04024-002