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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00794456 |
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Date of registration:
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19/11/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
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Scientific title:
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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 |
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Date of first enrolment:
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September 2009 |
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Target sample size:
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150 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00794456 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Brazil
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Contacts
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Name:
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Maria Elisabete A Moraes, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Ceará |
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Name:
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Antonio C Lopes, Phd |
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Address:
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Telephone:
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Email:
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Affiliation:
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Federal University of Sao Paulo - UNIFESP / DPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- generalized anxiety disorder
- HAM-A scale < 17 and > 30
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Anxiety Disorder
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Intervention(s)
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Drug: Passiflora ; Crataegus and Salix
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Drug: Valeriana
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Primary Outcome(s)
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Hamilton anxiety scale
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Insomnia gravity index; global clinical impression; patients global evaluation
[Time Frame: 6 weeks]
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Secondary ID(s)
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MJ 3002-08
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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