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Association of Passiflora Incarnata L; Crataegus Oxyacantha L and Salix Alba L. on Mild and Moderate Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00794456
Recruitment Status : Completed
First Posted : November 20, 2008
Last Update Posted : July 8, 2014
Sponsor:
Information provided by (Responsible Party):
Marjan Industria e Comercio ltda

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anxiety Disorder Drug: Passiflora ; Crataegus and Salix Drug: Valeriana Phase 3

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
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
 Drug: Valeriana
1 tablet PO twice a day
Other Name: Valeriana officinalis 50 mg


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton anxiety scale [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Insomnia gravity index; global clinical impression; patients global evaluation [ Time Frame: 6 weeks ]

Eligibility Criteria
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Information from the National Library of Medicine

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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Brazil
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
Sponsors and Collaborators
Marjan Industria e Comercio ltda
Investigators
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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
More Information
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Responsible Party: Marjan Industria e Comercio ltda
ClinicalTrials.gov Identifier: NCT00794456    
Other Study ID Numbers: MJ 3002-08
First Posted: November 20, 2008    Key Record Dates
Last Update Posted: July 8, 2014
Last Verified: July 2014
Keywords provided by Marjan Industria e Comercio ltda:
Passiflora
Crataegus
Herbal
Valeriana
anxiety
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders