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

This study is currently recruiting participants.
Verified May 2012 by Marjan Industria e Comercio ltda
Sponsor:
Information provided by (Responsible Party):
Marjan Industria e Comercio ltda
ClinicalTrials.gov Identifier:
NCT00794456
First received: November 19, 2008
Last updated: May 23, 2012
Last verified: May 2012

November 19, 2008
May 23, 2012
September 2009
December 2012   (final data collection date for primary outcome measure)
Hamilton anxiety scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00794456 on ClinicalTrials.gov Archive Site
Insomnia gravity index; global clinical impression; patients global evaluation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Anxiety Disorder
  • Drug: Passiflora ; Crataegus and Salix
    1 tablet PO twice a day
    Other Name: Pasalix
  • Drug: Valeriana
    1 tablet PO twice a day
    Other Name: Valeriana officinalis 50 mg
  • Experimental: 1
    Association of Passiflora incarnata L; Crataegus Oxyacantha L and Salix alba L.
    Intervention: Drug: Passiflora ; Crataegus and Salix
  • Active Comparator: 2
    Valeriana officinalis 50 mg
    Intervention: Drug: Valeriana
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Not Provided
Brazil
 
NCT00794456
MJ 3002-08
Yes
Marjan Industria e Comercio ltda
Marjan Industria e Comercio ltda
Not Provided
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
Marjan Industria e Comercio ltda
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP