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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marjan Industria e Comercio ltda
ClinicalTrials.gov Identifier:
NCT00794456
First received: November 19, 2008
Last updated: July 7, 2014
Last verified: July 2014
  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:


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 ]

Enrollment: 150
Study Start Date: September 2009
Study Completion Date: October 2013
Primary Completion Date: October 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794456

Locations
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
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: July 7, 2014
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 August 21, 2014