Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
Double Blind, Randomized Study, Controlled by Valeriana Officinalis, of Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Patients With Mild and Moderate Anxiety
1 other identifier
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2009
Typical duration for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2008
CompletedFirst Posted
Study publicly available on registry
November 20, 2008
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedJuly 8, 2014
July 1, 2014
4.1 years
November 19, 2008
July 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hamilton anxiety scale
6 weeks
Secondary Outcomes (1)
Insomnia gravity index; global clinical impression; patients global evaluation
6 weeks
Study Arms (2)
1
EXPERIMENTALAssociation of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.
2
ACTIVE COMPARATORValeriana officinalis 50 mg
Interventions
Eligibility Criteria
You may qualify if:
- generalized anxiety disorder
- HAM-A scale \< 17 and \> 30
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Unidade de Farmacologia Clínica - UNIFAC
Fortaleza, Ceará, 60430-270, Brazil
SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo
São Paulo, São Paulo, 04024-002, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
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
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2008
First Posted
November 20, 2008
Study Start
September 1, 2009
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
July 8, 2014
Record last verified: 2014-07