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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
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by Marjan Industria e Comercio ltda:

Primary Outcome Measures:
  • Hamilton anxiety scale [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insomnia gravity index; global clinical impression; patients global evaluation [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2009
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794456

Locations
Brazil
Unidade de Farmacologia Clínica - UNIFAC Recruiting
Fortaleza, Ceará, Brazil, 60430-270
Contact: Jonaina C Oliveira     55-85-32232600     jonaina.gu@ig.com.br    
Principal Investigator: Maria Elizabete A Moraes, MD            
SPDM - Associação Paulista para o Desenvolvimento da Medicina - Hospital São Paulo Recruiting
Sao Paulo, Brazil, 04024-002
Contact: Fernanda M Gazoni, MD     55-11-9658-0467     fmgazoni@hotmail.com    
Principal Investigator: Antonio C Lopes, Phd            
Sponsors and Collaborators
Marjan Industria e Comercio ltda
Investigators
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

No publications provided

Responsible Party: Marjan Industria e Comercio ltda
ClinicalTrials.gov Identifier: NCT00794456     History of Changes
Other Study ID Numbers: MJ 3002-08
Study First Received: November 19, 2008
Last Updated: May 23, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Marjan Industria e Comercio ltda:
Passiflora
Crataegus
Herbal
Valeriana
anxiety

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 22, 2013