Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety
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|ClinicalTrials.gov Identifier: NCT00794456|
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : July 8, 2014
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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.
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Disorder||Drug: Passiflora ; Crataegus and Salix Drug: Valeriana||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.
Drug: Passiflora ; Crataegus and Salix
1 tablet PO twice a day
Other Name: Pasalix
Active Comparator: 2
Valeriana officinalis 50 mg
1 tablet PO twice a day
Other Name: Valeriana officinalis 50 mg
- Hamilton anxiety scale [ Time Frame: 6 weeks ]
- Insomnia gravity index; global clinical impression; patients global evaluation [ Time Frame: 6 weeks ]
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- drug or alcohol dependence
- gastrointestinal ulcer history
- coagulation disorders
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794456
|Unidade de Farmacologia Clínica - UNIFAC|
|Fortaleza, Ceará, Brazil, 60430-270|
|SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo|
|Sao Paulo, Brazil, 04024-002|
|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|
|Responsible Party:||Marjan Industria e Comercio ltda|
|Other Study ID Numbers:||
|First Posted:||November 20, 2008 Key Record Dates|
|Last Update Posted:||July 8, 2014|
|Last Verified:||July 2014|