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| Sponsored by: |
Marjan Industria e Comercio ltda |
|---|---|
| Information provided by: | Marjan Industria e Comercio ltda |
| ClinicalTrials.gov Identifier: | NCT00794456 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Anxiety Disorder |
Drug: Passiflora ; Crataegus and Salix Drug: Valeriana |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
| 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 |
| Estimated Enrollment: | 150 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.
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Drug: Passiflora ; Crataegus and Salix
1 tablet PO twice a day
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2: Active Comparator
Valeriana officinalis
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Drug: Valeriana
1 tablet PO twice a day
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Brazil, Ceará | |
| Unidade de Farmacologia Clínica - UNIFAC | |
| Fortaleza, Ceará, Brazil, 60430-270 | |
| Principal Investigator: | Maria Elisabete A Moraes, MD | Federal University of Ceará |
More Information
| Responsible Party: | Marjan Industria e Comércio Ltda ( Janice Mascarenhas Marques ) |
| Study ID Numbers: | MJ 3002-08 |
| Study First Received: | November 19, 2008 |
| Last Updated: | November 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00794456 |
| Health Authority: | Brazil: National Health Surveillance Agency |
|
Passiflora Crataegus Herbal Valeriana anxiety |
|
Anxiety Disorders Mental Disorders |
